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Systematic Review

Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation: A Systematic Review

[version 1; peer review: 2 not approved]
Vanamala Lakshmi Vasavi
https://orcid.org/0000-0002-8331-0121
1, Janhavi Khandekar
https://orcid.org/0000-0001-9224-5694
1, Vijay Pratap Singh
https://orcid.org/0000-0003-0642-7155
1, Stephen Rajan Samuel
https://orcid.org/0000-0002-5636-2620
1, Molly Cynthia D’souza1
Vanamala Lakshmi Vasavi
https://orcid.org/0000-0002-8331-0121
1, Janhavi Khandekar
https://orcid.org/0000-0001-9224-5694
1, [...] Vijay Pratap Singh
https://orcid.org/0000-0003-0642-7155
1, Stephen Rajan Samuel
https://orcid.org/0000-0002-5636-2620
1, Molly Cynthia D’souza1
PUBLISHED 22 Apr 2022
Author details Author details
OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Manipal Academy of Higher Education gateway.

Abstract

Background: Physical Inactivity (PI) and sedentary behaviour are the most important and modifiable risk factors to prevent cardiovascular diseases (CVD). Cardiac rehabilitation (CR) is a multidisciplinary program for patients who have undergone cardiac surgeries. Through CR, monitoring physical activity (PA) is possible and may reduce the rate of rehospitalization. The pedometer is a device that is useful to track the step count of the person day to day. It helps in self-monitoring of PA. The purpose of this review was to summarise the evidence about the effect of pedometer-based exercise program in phase 1 and phase 2 CR.
Methods: Databases such as MEDLINE, Cochrane, Scopus, Embase, and Web of Science were searched. This search is limited to randomized controlled trials (RCTs), human trials, a 10-year period, and English language journals. Based on inclusion criteria of pedometer-based exercise programs in phase 1 (inpatient phase) and phase 2 (outpatient phase) of CR and exclusion criteria of studies using pedometer in maintenance phase CR. The primary outcome of the study is step count, while secondary is PA (in terms of time), heart rate, sedentary behaviour, and quality of life. This study quality was assessed by the Downs and Black’s checklist.
Results: The study includes 6 RCTs based on the inclusion and exclusion criteria. Most studies show a considerable increase in step count associated with increased patient PA. Few studies have explained a significant increase of PA in the study group and maintained for longer terms. More research is needed to determine the impact of cardiovascular risk factors.

Keywords

Cardiac rehabilitation, pedometer, physical activity, step count, fitness tracker, inpatient phase cardiac rehabilitation, outpatient phase cardiac rehabilitation

Corresponding author: Vijay Pratap Singh
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2022 Vasavi VL et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Vasavi VL, Khandekar J, Singh VP et al. Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation: A Systematic Review [version 1; peer review: 2 not approved]. F1000Research 2022, 11:451 (https://doi.org/10.12688/f1000research.109941.1) First published: 22 Apr 2022, 11:451 (https://doi.org/10.12688/f1000research.109941.1) Latest published: 22 Apr 2022, 11:451 (https://doi.org/10.12688/f1000research.109941.1)

Introduction

Cardiovascular diseases (CVD) are a group of diseases that involve the heart and the blood vessels. Coronary heart diseases, peripheral heart diseases, congenital heart diseases come under this group of CVDs. For the past 20 years, heart disease has been the leading cause of death worldwide. The number of deaths from heart disease climbed from approximately 2 million in 2000 to almost 9 million in 2019 (World Health Organisation [WHO] reveals leading causes of death and disability worldwide). Various risk factors which cause CVD are smoking, blood pressure, lipid level, diet, diabetes mellitus, physical activity (PA), and psychosocial characteristics (Balady et al. 2007).

Sedentary behaviour and Physical inactivity (PI) are two of the most modifiable risk factors for CVD worldwide (Young et al. 2016). PI has been linked to systemic pathophysiology, linked to the development of metabolic and cardiovascular disorders, osteoporosis, and some malignancies. Beginning a physically active lifestyle decreases the probability of developing these conditions and fatality (Fletcher et al. 2018).

PA is defined as any bodily movement produced by skeletal muscles that result in energy expenditure (Caspersen et al. 1985). A systematic review and meta-analysis (Dibben et al. 2018) focusing on PA and cardiac rehabilitation (CR) has concluded there is an increase of PA level through CR in patients with coronary heart disease. CR is an effective treatment for a wide range of heart disease patients. Cardiopulmonary fitness, psychological variables, and quality of life are improved, and morbidity and death are reduced (McMahon et al. 2017).

CVD is a leading cause of morbidity and mortality worldwide (Roth et al. 2017). Secondary prevention, such as provided through CR, is essential to recovery since cardiac patients are at high risk of recurring episodes and have a decreased quality of life (Mehra et al. 2020). CR is a multidisciplinary and multiphasic approach.

CR plays a significant role in preventing CVDs and helps recover the patients who have undergone cardiac surgeries. It consists of essential elements such as risk factor modification, exercise training, dietary suggestions, psychosocial counselling, and patient education. A customizable follow-up approach and simple access to a specialised team are also included in CR (European Association of Cardiovascular Prevention and Rehabilitation Committee for Science Guidelines 2010). The European Society of Cardiology (ESC) (Van de Werf et al. 2008), American Heart Association (AHA), and American College of Cardiology (ACC) (Antman et al. 2008) all recommend CR programmes in the management of patients with coronary artery disease (CAD) and chronic heart failure (CHF).

The patients' weekly amounts and intensities of physical activity frequently fell short of the prescribed limits, owing to a lack of physical activity on non-CR days (Ayabe et al. 2004). A systematic review has provided evidence of improved PA significantly associated with pedometer among out-patient adults (Bravata et al. 2007).

According to the AHA/ACC guidelines for secondary prevention of CVDs, a recommended PA ranges from minimum of thirty minutes for five days a week up to a maximum limit of sixty minutes for seven days per week. It includes moderate intensity workouts such as aerobic exercises; while resistance training is encouraged. Patients who come under high risk are suggested to perform these under medical supervision (Smith et al. 2006).

A pedometer is a form of activity tracker that helps people keep track of how many steps they take each day. It motivates the user by giving them instantaneous feedback on how many steps they have taken regularly. The self-monitoring of the PA via pedometers over an extended period impacts the outcome by increasing the PA levels (Ayabe et al. 2010). A pedometer-based intervention was linked to increased PA, improved psychological health, and improved cardiorespiratory fitness (Butler et al. 2009).

People can use a pedometer to assist them in boosting their PA level (Kaminsky et al. 2013). The use of pedometer determines step count for PA in CR. The PA results were significantly influenced by adherence to the step goal (Schneider et al. 2006).

Many researchers have previously conducted various systematic reviews, such as pedometer adherence to PA in the CHD population (Bravata et al. 2007) and also a few on maintenance phase of CR (Hannan et al. 2019). Furthermore, no systematic review has been conducted on studying pedometer use in inpatient and outpatient phases of CR.

In this systematic review, we aim to study the randomised control trails (RCTs) that are done phase 1 and phase 2 CR using a pedometer-based exercise program. The primary outcome measure of this study is pedometer-based step count. While the secondary outcomes are PA, sedentary behaviour, heart rate, and quality of life.

Methods

Inclusion criteria

This systematic review includes full-text articles limited to RCTs, human trials and published in English language journals. Studies that use a pedometer as part of the intervention in either the inpatient or outpatient phase of CR were included.

Exclusion criteria

Single group studies, non- RCTs, quasi-experimental studies, case series and studies, cross-sectional studies, and qualitative studies are also excluded. The studies which use pedometer-based mobile applications are excluded because according to the analyses, when compared to the pedometer, all the mobile applications had an unsatisfactory error percentage (Orr et al. 2015).

Literature search and study selection

The protocol of this systematic review was registered in Open Science Framework (OSF) with the registration DOI: 10.17605/OSF.IO/73WX4. MEDLINE (RRID:SCR_002185; URL: http://www.nlm.nih.gov/bsd/pmresources.html), Cochrane (RRID:SCR_013000; URL: http://www.cochrane.org/reviews/clibintro.html), Scopus (Elsevier, RRID:SCR_013811; URL: http://www.elsevier.com), Embase (RRID:SCR_001650; URL: http://www.elsevier.com/online-tools/embase), and Web of Science (Clarivate Analytics, RRID:SCR_017657; URL: https://clarivate.com) are the databases used to screen the articles. A search strategy was established for each database using keywords along with the MeSH terms and Boolean operators such as “AND” & “OR”. A search was performed to identify the articles using various keywords such as, for CR – cardiovascular rehabilitation, heart rehabilitation, coronary rehabilitation; for pedometer – activity tracker, fitness tracker, accelerometer, PA tracker, personal tracker; step count; for PA – aerobic exercises, aerobic training and physical exercise. This search was narrowed to the years 2011–2021 to include more relevant and recent research. This review aimed at performing a meta-analysis for synthesizing high-quality evidence.

The searches were performed by using the search strategy mentioned above and it retrieved the total number of 989 articles. With the help of a reference managing tool Zotero (version: 5.0.96.2; RRID:SCR_013784; URL: https://www.zotero.org), the duplicates of 292 articles were removed. The articles which did not fit the inclusion criteria are excluded during the title and abstract screening. Two authors screened the full-text articles, and a total of 6 articles were finalised for the review. The PRISMA flow chart of the review is presented in Figure 1.

7dc4c022-bba8-4921-bcd4-c4fb98982963_figure1.gif

Figure 1. PRISMA flow chart.

Study quality

The process of assessing the study quality of the included studies was done by two authors independently using the Downs and black’s checklist (Downs and Black, 1998) (https://www.researchgate.net/figure/Downs-and-Black-Checklist-for-Quality-Assessment_fig2_269766057). This checklist provides a 27-list questionnaire that determines the quality of the studies. It assesses the studies by reporting characteristics, external validity, internal validity-bias, internal validity-confounding, and power. The studies had been rated according to the questionnaire values and divided into excellent (26–28), good (20–25), fair (15–19), and poor (less than or equal to14) upon a total of 28.

Data extraction

Finalised articles were reviewed, and the primary author extracted relevant data. Data such as title, author, year of publication, total sample size, division of samples into intervention group and control group, and primary and secondary outcome measures were taken. The data tables of each article were screened for mean-standard deviation, confidence interval, and median – interquartile range.

We extracted secondary outcome data such as PA, heart rate, sedentary behavior, and quality of life. This data was from pre-intervention (baseline) and post-intervention time points. The percentage of completed samples, inclusion criteria, given intervention, frequency of sessions, dropout, and adverse events were extracted from all finalised articles. A second author checked this data while a third author resolved discrepancies. For additional data of the included studies, two authors were contacted and provided with the information (Midence et al. 2016; Thorup Msn et al. 2016).

Results

Study quality

All the included studies were RCTs. All the articles were eligible for the methodological quality assessment using the Downs and Black’s checklist. One study fell into the category of poor, given the insufficient information regarding blinding, allocation concealment, and follow-up details of patients (Thorup Msn et al. 2016). All the other studies were considered of good quality scoring in a range of 20–25 (Houle et al. 2011; Sangster et al. 2015; Midence et al. 2016; ter Hoeve et al. 2018; Gama Lordello et al. 2020). Randomisation was done in all the studies, where most of the studies mentioned the type of randomisation, blinding and allocation concealment. The adverse events were mentioned only in one study (Gama Lordello et al. 2020). The checklist of above study quality is presented in Table 1.

Table 1. Quality assessment using Downs and Blacks checklist.

Article author name and year:ter Hoeve et al. 2018Houle et al. 2011Midence et al. 2016Gama Lordello et al. 2020Sangster et al. 2015Thorup et al. 2016
Reporting
1. Is the hypothesis/aim/objective of the study clearly described?yesyesyesyesyesyes
2. Are the main outcomes to be measured clearly described in the introduction or methods section? If the main outcomes are first mentioned in the results section, the question should be answered no.yesyesyesyesyesyes
3. Are the characteristics of the patients included in the study clearly described? In cohort studies and trials, inclusion and/or exclusion criteria should be given. In case-control studies, a case-definition and the source for controls should be given.yesyesyesyesyesyes
4. Are the interventions of interest clearly described? Treatments and placebo (where relevant) that are to be compared should be clearly described.yesyesnoyesyesyes
5. Are the distributions of principal confounders in each group of subjects to be compared clearly described? A list of principal confounders is provided.nononononono
6. Are the main findings of the study clearly described? Simple outcome data (including denominators and numerators) should be reported for all major findings so that the reader can check the major analyses for conclusions. (This question does not cover statistical tests which are considered below).yesyesyesyesyesyes
7. Does the study provide estimates of the random variability in the data for the main outcomes? In non-normally distributed data, the inter-quartile range of results should be reported. In normally distributed data the standard error, standard deviation or confidence interals should be reported. If the distribution of the data is not described, it must be assumed that the estimates used were appropriate and the question should be answered yes.yesyesyesyesyesyes
8. Have all important adverse events that may be a consequence of the intervention been reported? This should be answered yes if the study demonstrates that there was a comprehensive attempt to measure adverse events. (A list of possible adverse events is provided).nononoyesnono
9. Have the characteristics of patients lost to follow-up been described? This should be answered yes where there were no losses to follow-up or where losses to follow-up were so small that findings would be unaffected by their incclusion. This should be answered no where a study does not report the number of patients lost to follow-up.yesyesyesyesyesyes
10. Have actual probability values been reported (e.g. 0.035 rather than <0.05) for the main outcomes except where the probability values are <0.001?yesyesyesyesyesyes
External validity. Are the following criteria attempt to address the representativeness of the findings of the study and whether they may be generalised to the population from which the subjects were derived.
11. were the subjects asked to participate in the study representative of the entire population from which they were recruited? The study must identify the source population for patients and describe how the patients were selected. Patients would be representative if they comprised the entire population, an unselected sample of consecutive patients, or a random sample. Random sampling is only feasible where a list of all the members of the relevant population exists. Where a study does not report the proportion of the source population from which the patients are derived, the question should be answered as unable to determine.yesyesyesyesyesyes
12. Were those subjects who were prepared to participate representative of the entire population from which they were recruited? The proportion of those asked who agreed should be stated. Validation that the sample was representative would include demonstrating that the distribution of the main confounding factors was same in the sample and the source population.yesyesyesyesyesyes
13. Were the staff, places, and facilities where the patients were treated, representative of the treatment the majority of the patients receive? For the question to be answered yes, the study should demonstrate that the intervention was representative of that in use in the source population. The question should be answered no if, for example, the intervention was undertaken in a specialist care center unrepresentative of the hospitals most of the source population would attend.yesyesyesyesyesyes
Internal validity- Bias
14. Was an attempt made to blind the study subjects to the intervention they have received? For studies where the subjects would have no way of knowing which intervention they received, this should be answered yes.yesnoyesyesnounable to determine
15. Was an attempt made to blind those measuring the main outcomes of the intervention?nounable to determineyesyesnounable to determine
16. If any of the results of the study were based on "Data dredging", was this made clear? Any analyses that had not been planned at the outset of the study should be clearly indicated. If no retrospective unplanned subgroup analyses were reported, then answer is yes.unable to determineunable to determineunable to determineunable to determineunable to determineunable to determine
17. In trials and cohort studies, do the analyses adjust for different lengths of follow-up of patients, or in case-control studies, is the time period between the intervention and outcome the same for cases and controls? Where follow-up was the same for all study patients the answer should yes. If different lengths of follow-up were adjusted for by, for example, survival analysis the answer should be yes. Studies where differences in follow-up are ignored should be answered no.yesyesyesyesyesyes
18. Were the statistical tests used to assess the main outcomes appropriate? The statistical techniques used must be appropriate to the data. For example nonparametric methods should be used for small sample sizes. Where little statistical analysis has been undertaken but where there is no evidence of bias, the question should be answered yes. If the distribution of the data (normal or not) is not described it must be assumed that the estimates used were appropriate and the question should be answered yes.yesyesyesyesyesyes
19. Was compliance with the intervention/s reliable? Where there was non compliance with the allocated treatment or where there was contamination of one group, the question should be answered no. For studies where the effect of any misclassification was likely to bias any association to the null, the question should be answered yes.yesyesyesyesyesyes
20. Were the main outcome measures used accurate (valid and reliable)? For studies where the outcome measures are clearly described, the question should be answered yes. For studies which refer to other work or that demonstrates the outcome measures are accurate, the question should be answered as yes.yesyesyesyesyesyes
Internal validity- Confounding (Selection Bias)
21. Were the patients in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited from the same population? For example, patients for all comparison groups should be selected from the same hospital. The question should be answered unable to determine for cohort and case control studies where there is no information concerning the source of patients included in the study.yesyesyesyesyesyes
22. Were study subjects in different intervention groups (trials and cohort studies) or were the cases and controls (case-control studies) recruited over the same period of time? For a study which does not specify the time period over which patients were recruited, the question should be answered as unable to determine.yesyesyesyesyesyes
23. Were study subjects randomised to intervention groups? Studies which state that subjects were randomized should be answered yes except where method of randomisation would not ensure random allocation. For example alternate allocation would score no because it is predictable.yesyesyesyesyesyes
24. Was the randomised intervention assignment concealed from both patients and health care staff until recruitment was complete and irrevocable? All non-randomised studies should be answered no. If assignment was concealed from patients but not from staff, it should be answered no.yesnoyesyesunable to determineunable to determine
25. Was there adequate adjustment for confounding in the analyses from which the main findings were drawn? This question should be answered no for trials if: the main conclusions of the study were based on analyses of treatment rather than intention to treat; the distribution of known confounders in the different treatment groups was not described; or the distribution of known confounders differed between the treatment groups but was not taken into account in the analyses. In nonrandomized studies if the effect of the main confounders was not investigated or confounding was demonstrated but no adjustment was made in the final analyses the question should be answered as no.nononononono
26. Were losses of patients to follow-up taken into account? If the numbers of patients lost to follow-up are not reported, the question should be answered as unable to determine. If the proportion lost to follow-up was too small to affect the main findings, the question should be answered yes.nononoyesyesno
Power
27. Did the study have sufficient power to detect a clinically important effect where the probability value for a difference being due to chance is less than 5%? Sample sizes have been calculated to detect a difference of x% and y%.yesyesunable to determineyesyesunable to determine
Total score:20/2820/2821/2825/2821/2819/28

Data extraction

Out of the 6 RCTs, three studies were three arm trails. Three articles mentioned primary outcome data which was step count in the format of Mean and standard deviation (Houle et al. 2011; ter Hoeve et al. 2018; Midence et al. 2016) (n=3, 50%), while one article had mentioned the data in the format of the median and interquartile range (Gama Lordello et al. 2020) (n=1, 16.67%). This step count data is presented in Table 2. Some articles did not mention step count values (Sangster et al. 2015), and few did not take the step count of the control group in account (Thorup Msn et al. 2016). Among all the studies, three studies performed pedometer-based cardiac telerehabilitation (n=3, 50%). Two studies considered cardiovascular risk factors (n=2, 33.33%). There was only one study which was of inpatient phase CR. The details of the interventions and outcome measures are summarised in Table 3.

Table 2. Step count data.

S.noAuthorSample sizePre intervention (study group)Post intervention (study group)Pre intervention (control group)Post intervention (control group)
Step countStep countStep countStep count
1ter Hoeve et al. 2018731CR+F: Mean ± SD: 6.9 ± 2.2(number of steps per min of wear time)CR+F: Mean ± SD: 8 ± 2.8(number of steps per min of wear time)CR: Mean ± SD: 7.3 ± 2.9(number of steps per min of wear time)CR: Mean ± SD: 7.5 ± 2.9(number of steps per min of wear time)
CR+T: Mean ± SD: 6.9 ± 2.6(number of steps per min of wear time)CR+T: Mean ± SD: 7.5 ± 2.8(number of steps per min of wear time)
2Houle et al. 201165Mean ± SD: 5845 ± 3246Mean ± SD: 9850 ± 3282Mean ± SD: 6037 ± 3055Mean ± SD: 7970 ± 3433
3Gama Lordello et al. 2020234Median (IQR)- 306(182-466)Median (IQR)- 302(198-464)Median (IQR)- 1126(869-1436)Median (IQR)- 972(766-1349)
4Midence et al. 2016169Mixed Sex: Mean ± SD: 5771.71 ± 2799.3Mixed Sex: Mean ± SD: 5872.72 ± 2797.4Home-Based: Mean ± SD: 6074.48 ± 3480.38Home-Based: Mean ± SD: 7802.61 ± 5792.55
Women only: Mean ± SD: 5390.76 ± 2675.18Women only: Mean ± SD: 6290.44 ± 3055.43

Table 3. Intervention description and the outcome measures.

Sr no.Author/yearSite of researchParticipantsPhase of CRIntervention DescriptionFrequency of sessionsTotal intervention time (in minutes)Outcome measures
1ter Hoeve et al. 2018NetherlandsAcute coronary sundrome diagnosis, age > 18 years, and proficiency in Dutch.Phase 2 CRCR+F: Standard CR + Evidence based behavioural change techniques - information about health behaviour, self-monitoring, goal setting, feedback, barrier identification, relapse prevention. Pedometer, booklet with assignments. Exercise program - aerobics. Counselling session - lifestyle management; CR+T: Standard CR + Telephone calls - motivational interviewing, define personal goals, psychosocial problems discussion, lifestyle management; CR: Standard CR - Gymnastic exercises, running/brisk walking, sports activities and relaxation exercisesCR+F: First 3 months - 3 face to face active life style counselling sessions of 75 mins each & Standard CR. Next 9 months - 3 sessions of exercise - 60 mins followed by face to face behavioural counselling for 60 mins; CR+T: First 3months - Standard CR. Next 9 months - 5 telephonic after care behavioural sessions; C: first 3 months - standard CR - 2 sessions per week- 75 minsCR - 1800 mins; CR+F- 2160mins; CR+T - 1800 mins; Total = 5760 mins.Step count, Physical activity, sedentary behaviour
2Houle et al. 2011CanadaPatients under 80 years old hospitalized for an acute coronary syndrome (unstable angina, non-ST elevation or ST elevation myocardial infarction)Phase 2 CRStudy group - Pedometer, diary and information regarding physical activity has given to patients. Exercise goal - walking at moderate intensity according to borg scale, target of per day increment in physical activity by 3000 steps. One phone call and 5 face to face consultations. Self-efficacy expectation- verbal persuasion, physiological states, vicarious experience, performance accomplishments; Control group - Received usual care.Study group - 5 face to face consultations - 60mins; Control group - not mentioned300 minsStep count, cardiovascular risk factors, change in self efficacy expectation
3Midence et al. 2016CanadaFemale patients, low risk cardiac patients, can speak/read English, eligible for home based CR, clearance given by physician.Phase 2 CRMixed sex CR: On site CR; Women only CR: On site CR + Education sessions; Home based CR: Exercises at home and received calls at various intervalsMixed sex CR: 1-2 sessions per week of 60 mins, for 4-6months; Women only CR: 1-2 sessions per week of 60 mins, for 4-6months; Home Based CR: 150 mins per week target for 4-6 monthsmixed sex CR - 2880mins, Women only - 2880 mins, home based CR - 3600 minsStep count, diet habit survey, physical activity, social activity, quality of life
4Gama Lordello et al. 2020BrazilAge - ⩾18 years, patients who had been undergone cardiac surgery, either elective myocardial revascularization or valve surgery by median sternotomy with extracorporeal circulationPhase 1 CRstudy group - In ICU: Cycle ergometer: Arm exercises - 60 degree, leg exercises - 30 degree lowering of head end; In Wards - breathing exercises, stretching, progressive physical activity according to individual capacity followed by ICU exercises; Control group - active lower limb and upper limb exercise, open kinematic chain, flexion - extension of shoulder, diagonal movements - cross body, straight leg raises, hip and knee flexion extension, ankle pumps; In Wards - breathing exercises, stretching, progressive physical activity according to individual capacity followed by ICU exercisesStudy group - ICU: 10 mins session twice a day till patient discharged from ICU; Wards: twice a day session; Control group - ICU: 10 mins session twice a day till patient discharged from ICU; Wards: twice a day sessionunable to determineStep count, cardiovascular risk factors
5Sangster et al. 2015SydneyPatients referred to outpatient CR, English speaking, patients who are capable of moderate physical activityPhase 2 CRHealthy weight group: Lifestyle calendar, pedometer, behavioural and goal setting sessions, telephone call sessions on weight, nutrition, physical activity and weight loss; Physical activity group: Pedometer, step recording calendar, telephone session for behavioural and goal setting sessions along with physical activityHealthy weight group: Dosage has given according to BMI range - >25kg/m2-60-90mins of high-volume physical activity for 6 days in a week, 18.5-24.9 kg/m2-30min sessions 5 days a week for 8 months + 4 telephone call sessions + two booster calls; Physical activity group: 30 mins of physical activity for 6 days a week + 2 telephone call sessions + 2 booster callsHealthy weight group: 17280, Physical activity: 5760BMI, Physical activity
6Thorup et al. 2016DenmarkPatients hospitalized with acute coronary syndrome (ACS), heart failure (ejection fraction <40%), coronary artery bypass graft (CABG), or valve replacement/mitral valve repair, Danish speaking.Phase 2 CRStudy group - Step counter, scale, sphygmomanometer, and a tablet consisting of personalised health program. Call centre: follow up, self-monitoring and step count. Health care centre: individual and group sessions, follow up, group consultations, self-monitoring, and step count. Hospital: Individual and group sessions, consultation, follow up, self-monitoring and step count; Control group - Traditional cardiac rehabilitationStudy groups - Call centre: time based on individual needs. Health care centre: time based on individuals needs and 2 sessions per week for 12 weeks. Hospital: time based on individuals needs and 2 sessions per week for 12 weeks; Control group - not mentionedunable to determineStep count, physical activity

Results of individual studies

Owing to the variability among the included studies in terms of methodology and outcome measures presented, the results of the individual studies have been summarised and provided narratively since it was not possible to pool the data in a meta-analysis approach.

Improvement in step count: Significant increase in step count has been shown in three studies, while one study could not show a statistical significance in the step count. ter Hoeve et al. (2018) reported an overall significant increase of step count in the intervention group (p=0.010) with a pedometer and face-to-face counselling sessions compared to the tele-rehabilitation group and control group (p=0.307). In the Gama Lordello et al. (2020) study, the total number of steps taken in the study group were 2183 (1729–2772) and in the control group were 2006 (1517–2657). However, there was an increase in steps taken in the study group, although the difference was not statistically significant (p=0.167).

Improvement in PA: Out of six studies, four studies observed the patients' PA levels in adherence to the pedometer. Though there was an increase in both the study and control group, only a few studies noted a significant increase of PA in the study group that was maintained for longer terms (Sangster et al. 2015; ter Hoeve et al. 2018). Sangster et al. (2015), saw an improvement of PA from p=0.23 to p=0.15, while ter Hoeve et al. (2018), observed the difference between the PA levels by p=0.165 (CR+F [cardiac rehabilitation along with face-to-face counselling) vs. CR] and p = 0.331 [CR+T (cardiac rehabilitation along with telerehabilitation) vs. CR].

Improvement in cardiovascular risk factors: Houle et al. (2011), and Gama Lordello et al. (2020), considered cardiorespiratory fitness and observed the pre- and post-intervention differences in both the study and control groups. Based on heart rate, both the studies showed a significant statistical effect. The study by Houle et al. (2011) described the lipid profile, fasting blood glucose, waist circumference, blood pressure, and smoking. Of which, waist circumference was shown to have a statistically significant effect, while smoking was seen to have a less significant role. Midence et al. (2016) also observed that the factors such as heart rate and smoking had no significant difference.

Improvement in sedentary behaviour and psycho-social factors: One study observed the sedentary behaviour in their participants but no changes were seen in the results from baseline to the post-intervention sessions (ter Hoeve et al. 2018). Psycho-social factors are explained in three out of six studies in the form of either social support, quality of life, self-reported reasons for decreased walking, and self-efficacy expectation. Increased quality of life (QoL) has been seen in the study of Midence et al. (2016) while social support showed no significant changes in the same study. Reasons reported by the patients for decreased walking were noted in the study by Gama Lordello et al. (2020).

Discussion

The significant finding of this review is a substantial increase in PA noted as step count on pedometer adherence in patients undergoing phase 1 and 2 CR. The possible reasons that cause an increase in the step count results stated by the studies were- the instantaneous input on step activity leading to conscious awareness of walking action (Thorup Msn et al. 2016); objective feedback by the pedometer itself along with the follow-up counselling sessions (ter Hoeve et al. 2018).

A pedometer is a helpful device that helps track the person’s PA while performing the exercise. It enhances adherence by giving visual feedback of the achieved PA target and acts as an incentive for the upcoming goals (Bravata et al. 2007). Patients were motivated to meet their step objectives because they expected health advantages and had become aware of walking as a beneficial activity (Thorup et al. 2016). This may be considered as extrinsic motivation from an self-determination theory (SDT) viewpoint since the incentive is not the act itself (walking), but the expected outcomes of the act (health benefits), however the motivation appears to be integrated (Deci and Ryan 2000).

In this review, a study that have used pedometer-based interventions suggested exercises like gymnastic exercises, running/brisk walking, sports activities, and relaxation exercises (ter Hoeve et al. 2018). According to the Borg scale, the researchers have set an exercise goal of increasing patients’ walking activity by 3000 steps daily of moderate-intensity (Houle et al. 2011). Along with this pedometer, the patients maintained a step count diary to record their regular PA or to note the daily step count achieved.

Only one study has performed an inpatient phase CR. In this study, the intervention group was given a cycle ergometer for arm and leg exercises. In contrast, the control group were recommended regular exercises such as activity for lower and upper limbs, open kinematic chain, flexion-extension of the shoulder, diagonal movements - cross body, straight leg raises, hip and knee flexion-extension, ankle pumps in the intensive care unit (ICU). As the patients were shifted out of ICU, additional exercises such as breathing exercises, stretching, progressive PA according to individual capacity followed by ICU exercises were given in both the groups (Gama Lordello et al. 2020).

Few studies followed up via telephonic sessions for the aftercare program (Houle et al. 2011; Sangster et al. 2015; Thorup Msn et al. 2016; ter Hoeve et al. 2018). While lifestyle management counselling was also given by two out of six studies (Sangster et al. 2015; ter Hoeve et al. 2018). The telephonic sessions may have proved to be encouraging in terms of constant monitoring on the patient’s PA and their results.

This systematic review comprises the information of various forms of pedometer-based interventions. Unfortunately, a meta-analysis could not be done as the data obtained was heterogeneous. In terms of research design and statistical analysis, the four studies chosen for the meta-analysis were diverse in their approach. Two of the four studies were three-group studies, with one having two intervention groups and one control group (ter Hoeve et al. 2018), and the other having three separate intervention groups (Midence et al. 2016). The outcome variables in the other two trials were mean-standard deviation and median-interquartile range, respectively (Houle et al. 2011; Gama Lordello et al. 2020). This review included all RCTs and tried to provide high-level evidence to support objective of the study. Adding on, five out of six studies included in this study have a low risk of bias and one with a moderate risk of bias.

Limitations

This systematic review has included all possible evidence obtained on the pedometer and CR. The exclusion of certain mobile application-based pedometers may have created a window of bias in this review. Furthermore, a meta-analysis was not possible as less evidence was available in the RCT study design. Limited reporting of statistical analysis and relevant data tables could have reduced the chances of a meta-analysis (Sangster et al. 2015; Thorup Msn et al. 2016; Su and Yu 2019).

Future directions

More research should be done to compare the effects of using a pedometer in both control and intervention groups. As the heart rate was not examined in many trials, potentially widening the information gap, this analysis indicates that future RCTs might be developed using heart rate as one of the key outcome measures. According to one study, step rates of 130, 140, and 150 steps per minute are equivalent to the exercise intensity required to improve cardiorespiratory fitness levels (65%–75%) heart rate maximal (Lubans et al. 2009).

Conclusion

According to the findings of this systematic review, using a pedometer in the early phases of CR may encourage PA and help patients adhere to their exercise regimen. This may aid in preventing CVD and the re-hospitalization of patients.

Data availability

Underlying data

Open Science Framework: “Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation.” https://doi.org/10.17605/OSF.IO/8TPJ5

This project contains the following underlying data:

Data file 1- Table 1: Quality assessment using Downs and Blacks checklist

Data file 2- Table 2: Step count data

Data file 3- Table 3: Intervention description and the outcome measures

Data file 4- Figure 1 – PRISMA flow chart

Data file 5- PRISMA checklist

Data file 6 – Systematic review protocol

Extended data

Open Science Framework: “Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation.” https://doi.org/10.17605/OSF.IO/8TPJ5

This project contains the following extended data:

Data file 1- Supplementary table 1

Data file 2- Supplementary table 2

Reporting guidelines

Open Science Framework: PRISMA Checklist for article “Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation”, https://doi.org/10.17605/OSF.IO/8TPJ5.

Data are available under the terms of the Creative Commons Zero “No rights reserved” data waiver (CC0 1.0 Public domain dedication).

Author contributions

Vanamala Lakshmi Vasavi- Conceptualization, Methodology, Writing – Original Draft Preparation, Writing – Review & Editing.

Janhavi Khandekar- Methodology, Writing – Original Draft Preparation, Writing – Review & Editing.

Dr. Vijay Pratap Singh- Conceptualization, Methodology, Writing – Original Draft Preparation.

Dr. Stephen Rajan Samuel- Conceptualization, Writing – Review & Editing,

Molly Cynthia D’souza- Supervision, Writing – Review & Editing.

Supplementary table 1- Keywords used: Strategy builder

Supplementary table 2- Synonyms and keywords

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Vasavi VL, Khandekar J, Singh VP et al. Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation: A Systematic Review [version 1; peer review: 2 not approved]. F1000Research 2022, 11:451 (https://doi.org/10.12688/f1000research.109941.1)
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Reviewer Report 16 Nov 2023
Shweta Gore, Physical Therapy, MGH Institute of Health Professions, Boston, MA, USA 
Not Approved
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https://doi.org/10.5256/f1000research.121502.r139602
The premise of this study adds little value to the scientific body of evidence. Pedometers have been previously studied in systematic reviews and have shown to significantly underestimate activity. The validity of pedometers has been questioned in several studies. 
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Gore S. Reviewer Report For: Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation: A Systematic Review [version 1; peer review: 2 not approved]. F1000Research 2022, 11:451 (https://doi.org/10.5256/f1000research.121502.r139602)
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Eiichi Watanabe, Fujita Health University, Nagoya, Japan 
Not Approved
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https://doi.org/10.5256/f1000research.121502.r182739
Lakshmi Vasavi and colleagues conducted a systematic review of randomized controlled studies to examine the effects of a pedometer-based exercise program. Six studies were included based on predetermined exclusion criteria.

Major comment:
While the methodology is ... Continue reading
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Watanabe E. Reviewer Report For: Effectiveness of pedometer-based exercise program in phase 1 and phase 2 cardiac rehabilitation: A Systematic Review [version 1; peer review: 2 not approved]. F1000Research 2022, 11:451 (https://doi.org/10.5256/f1000research.121502.r182739)
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  1. Eiichi Watanabe, Fujita Health University, Nagoya, Japan
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