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Study Protocol

Effectiveness of comprehensive cognitive and balance training strategies (CCBTS) on gait, balance, quality of life, and fall-related self-efficacy among institutionalized elderly in Udupi District: A mixed-method study protocol

[version 1; peer review: 2 approved with reservations]
PUBLISHED 26 Apr 2022
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This article is included in the Manipal Academy of Higher Education gateway.

Abstract

Background: The geriatric population is at high risk for gait and balance-related issues as they grow older. The gait and balance-related issues then causes them to be more vulnerable to a fall. Following a fall, the psychological impact could result in fear of falling and decreased quality of life (QoL) in later life. This mixed-method study protocol was developed to evaluate the effectiveness of cognitive and balance training on gait, balance, fall-related self-efficacy, and QoL among institutionalized older adults.
Methods: A sequential explanatory study has been designed with phase I as quantitative (QUAN) and phase II as qualitative (qual). A randomized controlled trial will be conducted to determine the effectiveness of combined cognitive and balance training among older adults. An in-depth interview will be conducted in phase II with thematic analysis to determine the phase II objectives. A nested sampling technique will be used, wherein the phase II participants will be selected from phase I. In phase I, the intervention arm will receive both cognitive and balance training whereas the control arm will receive only balance training. The phase II participants will be selected from the institutionalized older adults who show improved and not improved fall-related self-efficacy and QoL after comprehensive cognitive and balance training strategies (CCBTS) training. The outcome variables included in the phase I study are gait, balance, fall-related self-efficacy, and QoL.
Conclusions: Cognitive training and balance training as a stand-alone intervention has proved their impact among older people. The gait and balance issue could impact from the consequences of both cognitive decline and physical decline; hence the proposed research would highlight the need for combined intervention to enhance overall well-being among the geriatric population.
Registration: This study is registered with The Clinical Trials Registry - India (CTRI); CTRI reference ID: CTRI/2016/11/007449; registered on 08/11/2016.

Keywords

Circuit-based exercise, Gait, Postural balance, Quality of life, Aged, Fear, Randomized Controlled Trial, Qualitative research

Introduction

Over the past two decades the age structure of the world’s population has taken a momentous shift due to declining fertility and mortality (Private, Health, Conference, & Insurance, 2014). Globally, the portion of older population (aged 60 years and above) has increased from 9% in 1994 to 12% in 2013, which is expected to reach 21% by 2050 (UN, 2013).

The annual growth rate of the geriatric population will be almost triple the growth rate of the total global population. In absolute terms, the percentage of the geriatric population has almost doubled between 1994 and 2014. From 1994 to 2014, there has been a major increase in the number of older adults in Asian countries (225 million), accounting for almost two thirds (64%) of global growth (UN, 2014).

In India, an individual aged 60 years and older is known as a ‘geriatric population’ (Giri, 2011). The demographic summary portrays that, in the years 2000-2050, the total population in India will rise by 55%, while the population of senior citizens will increase by 36%. Census of India 2001 data showed that older adults made up 7.7% of the whole population, which increased to 8.14% in the 2011 census. The predictions for the older population in the succeeding four censuses are: 133.32 million (2021), 178.59 (2031), 236.01 million (2041) and 300.96 million (2051) (MOHFW, 2011). The geriatric population in India has gone up from 6.0% in 1991 to 8.0% in 2011, whereas in Karnataka the total percentage of older adults constitute 8.4% (Census of India, 2011).

Due to advancing age, older adults usually complain about forgetting names, dates and appointments. Another major effect of age-related change is cognitive decline and its impact on gait and balance (Doumas, Rapp, & Krampe, 2009; Segev-Jacubovski et al., 2011). Impairment in any of the executive functions like visuo-spatial perception, self-awareness, response inhibition, attention or dual tasking may affect one’s ability to walk efficiently and safely (Salthouse et al., 2003; Salthouse, 2005).

Among the Indian geriatric population, fall prevalence was about 14-53%. The factors contributing to the occurrence of fall are multifactorial and age is one of the factors (Krishnaswamy & Usha, 2006). World Health Organization (WHO) declared fall among older adults as a public health burden because of the highest number of injuries and death related to fall (Todd & Skelton, 2004).

The geriatric population usually limit their daily activities due to psychological consequences of fall, i.e., fear of falling. The incidence of fall among the geriatric population does not normally occur during their normal walk, whereas when they are doing a secondary task (talking while walking, concentrating on other things, changing an object, walking across a busy road etc.) along with walking, they are more prone to a fall incident (Silsupadol, 2008).

Fear of falling among older adults may also lead to reduced activity, enhanced decline in physical functioning, and general diminishment of quality of life (QoL). Furthermore, restricting mobility because of fear of falling may itself be a risk factor for falls. The strong and consistent association of fear of falling with reduced QoL is an important public health issue (Kato et al., 2008).

A systematic review done in the USA (Kueider, Parisi, Gross, & Rebok, 2012) on computerized cognitive training with older adults, shows that compared to traditional cognitive training programmes, computer assisted cognitive training programmes have numerous benefits like customized training based on individual ability and can be used as a recreational modality among institutionalized older adults. There is an usual misconception about older adults that they won’t enjoy learning how to use new technology. Regardless of many older individuals reporting anxieties about using new technology at the commencement of training, after training most described great levels of understanding (Lee, Chen, & Hewitt, 2011).

A study conducted (Smith-Ray et al., 2015) in Chicago, with an objective to evaluate the effectiveness of a cognitive enhancement training intervention on gait and balance among cognitively intact older adults revealed that there was a significant improvement in Berg Balance Scale (BBS) score (F (1, 31) = 4.709, p = .038), gait speed (F (1, 29) = 6.57, p = .016) and mean distracted gait speed (I; μ = –0.86, C; μ = –0.39) in the intervention arm compared to the control arm.

A study was done by Verghese, Mahoney, Ambrose, Wang, and Holtzer (2010) in New York to evaluate the effectiveness of cognitive training on gait among sedentary older adults. It concluded that compared to baseline, gait velocity during usual walking (68.2 ± 20.0 vs 76.5 ± 17.9 cm/s, p = .05) and talking while walking (36.7 ± 13.5 vs 56.7 ± 20.4 cm/s, p = .002) improved a lot after the cognitive remediation.

An investigation was conducted by Theill, Schumacher, Adelsberger, Martin, and Jäncke (2013) in Switzerland to find the combined effect of physical and cognitive training among older people. The study results show that the concurrent training of cognitive and physical capabilities facilitated to progress cognitive and motor-cognitive dual task performance. Between the groups there was a significant difference in gait velocity reduction (F (1.58) = 3.165, p = .05, R2 = .098) but not in increase of step-to-step variability, offering better potential on activities of daily living among older adults.

A systematic review was conducted at Manipal, Karnataka (Dsouza, Rajashekar, Dsouza, & Kumar, 2014) to identify fall prevention strategies for older adults. They reviewed a total of 18 research articles. They report that the common strategies adopted to prevent fall among the geriatric population are nutritional interventions, visual and depth perception, balance training, balance and mobility training, ankle exercises, balance training under dual task conditions with graded sensory context, yoga, and Ayurveda.

Research gap

Many research studies were done to improve motor strength as well as gait and balance among older adults. At the same time new research is being done to improve the gait and balance through cognitive training as well. But the geriatric population are an age group where both physical and cognitive decline occurs and we need to address it together, not as stand-alone issues. So, this research is interested in evaluating the combined efficacy of cognitive and physical training in improving gait, balance, fall-related self-efficacy and QoL among institutionalized older adults, as no such studies have been done so far among the Indian geriatric population.

Need and significance of the study

The literature search and the researcher’s experience in dealing with older adults revealed that, older individuals are prone to have gait and balance disturbance due to aging. As age increases there will be physical as well as cognitive decline, which results in impairment in gait and balance, thus increasing the risk of fall among them. Fear of falling is the major hindering factor contributing to the lack of confidence in doing daily activities among older adults, which in turn leads to poor QoL.

Therefore, the researchers felt the need to conduct a study to evaluate the effect of comprehensive balance and mobility training strategies among institutionalized older adults to improve gait, balance, fall-related self-efficacy and QoL. The proposed research study will help older adults to build confidence to manage their activities of daily living.

The objectives of the study are to:

  • determine the effectiveness of comprehensive cognitive and balance training strategies (CCBTS) in terms of improvement in:

    • gait

    • balance

    • fall-related self-efficacy

    • QoL

  • describe the experiences of institutionalized older adults undergoing CCBTS with regard to change in (improved and not improved) QoL and fall-related self-efficacy.

Methods

Research approach

Based on the nature of the problem being studied, and the purpose and objectives of the study, a mixed method approach was found to be feasible to evaluate the effectiveness of CCBTS in improving gait, balance, fall-related self-efficacy and QoL among institutionalized older adults. This study protocol is reported in line with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines (Assariparambil et al., 2022b).

Research design

From the different research designs under the mixed method paradigm, explanatory sequential design (Creswell & Clark, 2018) quantitative (QUAN) → qualitative (qual), is found suitable for the present study as the researcher was interested to find reason or in-depth information (in the qual second phase) from the positive-performing exemplars and outlier results of the quantitative (randomized controlled trial (RCT)) first phase.

Phase I: QUAN phase

For the first phase of the mixed methods explanatory sequential study, an RCT is found to be appropriate, as the study focuses on evaluating the effectiveness of CCBTS in terms of improvement in gait, balance, fall-related self-efficacy and QoL among institutionalized older adults. Phase I of the study has two arms, i.e., intervention and control arm. Subjects in the intervention arm will receive both cognitive and physical training as the treatment along with routine care and the control arm subjects will receive physical training alone along with routine care (Machin & Fayers, 2010) (Jadad, 1998). Participants will be informed that trial enrolment is purely on a voluntary basis, and they can quit or discontinue the trial at any time. Once participants are allocated to the study arms, they will not be allowed to change the arm. If any participants would like to withdraw from the study, they can do so by informing the trial coordinator/researcher. As the intervention is done under the supervision of the researcher, it would enhance the intervention.

Randomization procedures

Type of randomization: To reduce the chance of encountering selection bias and to ensure balance in participants’ allocation within the subgroups, a restricted randomization scheme, Stratified Block Randomization will be adopted.

Stratification: Age wise strata is considered for the study. A total of three strata will be included based on the participant’s age; 60-65 years: Strata I, 66-70 years: Strata II, and 71-75 years: Strata III.

Sequence generation: The random allocation sequence will be generated adopting the principles of probability by using an online randomizer software, Research Randomizer (Research Randomizer, RRID:SCR_008563), and with the help of a statistician.

Allocation concealment: Allocation of the participants to the groups will be concealed until the end by employing Sequentially Numbered, Opaque, Sealed Envelopes (SNOSEs). SNOSEs will be prepared by an external person, who is not directly involved in this project. The prepared SNOSEs will be kept with the research supervisor for the central allocation. Upon completion of the screening assessment, the research supervisor will be contacted to get the allocation status of those who meet the eligibility criteria and provide consent based on the strata in which the participant belongs to.

Blinding: The outcome assessors will be unaware of the allocation status, and they will do the post-test assessment at the 5th and 10th week of intervention. Inter-rater reliability of the outcome assessors needs to be established before the outcome assessment.

Manipulation/intervention

The manipulation/intervention in this study i.e., CCBTS refers to a combination of cognitive and balance training program given to the institutionalized older adults with a purpose of enhancing their gait, balance, fall-related self-efficacy and QoL. It includes:

Cognitive training: In this study three computer based cognitive training games will be used to target the cognitive domains like visuospatial working memory, speed of processing, inhibition and attention. It is a researcher supervised training, it includes Double Decision, divided attention and target tracker developed by Posit Science, Brain HQ.

Balance training: In this study balance training refers to researcher-supervised exercises intended to improve muscle strength and balance among institutionalized older adults. This training is adopted from the National Health Service (NHS) training for older adults, it includes exercises like sit to stand, mini squat, calf raise, sideways walking, and one leg stands.

The experimental arm will receive a combination of both cognitive and balance training along with routine care as the researcher intends to determine the combined effect of both cognitive and balance training in improving the functional status of institutionalized older adults. Cognitive exercises will be practiced by the participants along with the researcher using laptops in a face-to-face, one-to-one interaction. The balance training will be done after the cognitive exercises.

Phase II: qual phase

To accomplish the objective of the second phase of this mixed method study, a qualitative approach will be adopted. The aim of the qual strand is to understand in depth experiences of institutionalized older adults in undergoing CCBTS intervention program in view of its impact over fall-related self-efficacy and QoL. In-depth interviews will be conducted among institutionalized older adults to determine who shows improvement and who does not show any improvement in fall-related self-efficacy and QoL in the intervention group. A thematic analysis (TA) method of the qualitative design will be adopted for the present study. TA (Braun et al., 2019; Braun & Clarke, 2006, 2019; Clarke & Braun, 2017) is a qualitative method aimed at understanding the pattern or themes within qualitative data collected from the participants. Table 1 represents the schematic representation of the study design.

Table 1. Table showing a representation of the study design.

Quantitative
RandomizationArmsPretest measurements
After allocation
Intervention
X
Post-test measurements
Follow up
5th week
(Post-test one: out of 15 days of training, those who completed minimum of 13 days will be considered i.e., 780 mts)
10th week
(Post-test two: out of 30 days of training, those who completed minimum of 26 days will be considered i.e., 1600 mts)
RIntervention armO0
Gait
Balance
Fall related self-efficacy
Quality of life (QoL)
Intervention arm
Comprehensive Cognitive and Balance Training Strategies (CCBTS)
1.Cognitive training (10 weeks)
2.Balance training (10 weeks)
(Same day one after another)
O1
Gait
Balance
Fall related self-efficacy
QoL
O2
Gait
Balance
Fall related self-efficacy
QoL
RControl armO0
Gait
Balance
Fall related self-efficacy
QoL
Control arm
Balance training (10 weeks)
O1
Gait
Balance
Fall related self-efficacy
QoL
O2
Gait
Balance
Fall related self-efficacy
QoL

Research setting

Institutions for older adults in Udupi District. As per the ministry of social justice and empowerment, Government of India directives, all care homes across the country have to be registered with their respective district administration. The list of care homes will be obtained from district senior citizen welfare department under the district administration.

Population

Institutionalized older adults of Udupi District will be the target population.

Sample and sampling technique

The sampling technique will be based on the advanced typology of mixed methods sampling design by Onwuegbuzie (2007), a nested sampling technique will be adopted for this study.

Phase I: QUAN: A purposive sampling technique will be used to recruit potential trial participants initially. Institutionalized older adults who meet the sample inclusion criteria will be recruited. Later those participants will be randomly assigned in to experimental or control arm.

Phase II: qual: A criterion sampling under the purposeful sampling technique (Patton, 2005) is found to be most appropriate for the qual strand of this mixed method study. The criteria used in this study is from the phase I intervention arm, institutionalized older adults who show improved and not improved fall-related self-efficacy and QoL after CCBTS training.

Sampling criteria

Phase I: QUAN

Inclusion criteria

  • Aged 60-75 years

  • Those who are able to read or write English or Kannada

  • Score of ≥ 26 on the Montreal Cognitive Assessment (MoCA)

  • Score of ≤ 8 on the Short-form Geriatric Depression Scale

  • Muscle strength of ≥ 4 for the lower limb as per the Medical Research Council London

Exclusion criteria

  • Presence of balance or walking impairment

  • Those who completed a balance training program within the previous year

  • Visual acuity of < 20/80

  • On psychotropic medications

  • Score ≤ 74 on Modified Barthel Index (MBI)

  • Diagnosed with chronic health conditions (symptomatic cardiac condition, post stroke, parkinsonism, cancer patients on active treatment, diagnosed vestibular disorders)

Phase II: qual

Inclusion criteria

Institutionalized older adults from the phase I intervention arm, those who show improved (reduction in Falls Efficacy Scale (FES) score ≥ 20 and increase in QoL score ≥ 15 from baseline) and not improved (reduction in FES score ≤ 10 and increase in QoL score ≤ 10 from baseline) fall-related self-efficacy and QoL after CCBTS training.

Sample size: (QUAN)

Sample size is calculated by using the following formula

n=2Z1α2+Z1β2σ2d2

Z1-α/2 –1.96 at α 0.05 level of significance

Z1-β – 0.84 for power of 80%

σ-Standard deviation of the observation = 1.3 based on previous study (Nitz & Choy, 2004)

d – Clinically significant difference =0.8 for TUG Scale

Attrition rate = 30%

Calculated sample size is 60 in each group (three strata, block size: eight, total blocks: five)

Sample size: (qual)

For the qualitative approach, data will be collected after the 10-week intervention, from the intervention arm, each stratum (i.e., from those who improved and did not improve QoL and fall-related self-efficacy) until data saturation occurs.

The trial participants are the residents of the care homes and they are performing the intervention under the direct supervision of the researcher. Repeated contact and frequent follow-ups will be made, hence drop outs can be minimized. To promote the retention of participants, frequent reinforcements will be given, and they will be encouraged to continue with the exercise and cognitive training.

Data collection instruments

Instruments used for screening the participants:

Phase I: QUAN

Tool 1: Sociodemographic proforma

This tool (Assariparambil et al., 2022a) is developed by the researcher to collect sociodemographic data from the institutionalized older adults. The proforma consists of 20 items such as age, sex, religion, educational status, marital status, previous occupation, number of children, and residential area of family.

Tool 2: Basic health check-up

The basic health check-up tool (Assariparambil et al., 2022a) comprises of 13 items to determine general well-being of the institutionalized older adults. The items included are height (in cm), weight (in kg), body mass index (BMI) (kg/m2), Heart rate (HR), Respiratory rate (RR), and Blood pressure (BP).

Tool 3: Modified Barthel Index (MBI)

MBI is a tool derived from Barthel Index (Mahoney & Barthel, 1965) instrument that aims to measure an individual’s ability to perform activities of daily living and mobility. A score ≤ 74 in MBI is an exclusion criterion of this trial.

Tool 4: Short-form geriatric depression scale

The short-form geriatric depression scale (Sheikh & Yesavage, 1986) is a self-rating scale that consists of 15 dichotomous items used to assess symptoms of depression among the older population. Individuals with a score ≥ 8 will not be included in this trial.

Tool 5: Montreal Cognitive Assessment (MoCA)

The MoCA is an instrument used to screen cognitive abilities of an individual to determine mild cognitive impairment. The total score that can be obtained is 30 and scores ≥ 26 are considered as normal thus institutionalized older adults with scores ≥ 26 will be included in this study.

Tool 6: Muscle strength examination

Muscle strength examination of the participants will be assessed based on the Manual Muscle Test (MMT), a standardized test that is used to assess muscle strength and function (Jellinger, 2001). As per the MRC muscle strength assessment, any institutionalized older adults with ≥ 4 score will be enrolled in the trial.

Instruments used for outcome assessment

  • i. Balance

Tool 1: The Berg Balance Scale (BBS)

BBS (Berg et al., 1989) is a 14 item instrument used to assess the balance and fall risk among individuals.

Tool 2: Timed Up and Go Test (TUG)

The TUG (Podsiadlo & Richardson, 1991) is a standardized test used to determine the mobility, balance, walking ability and risk for fall among older adults.

Tool 3: Functional Reach Test (FRT)

FRT (Berg et al., 1992) is used to determine the patient’s stability in balance and functional mobility.

Tool 4: Lateral Reach Test (LRT)

LRT (Brauer et al., 1999) is used to determine the medio-lateral postural stability of older adults to identify balance ability as a predictor of risk for fall.

  • ii. Gait

Tool 1: 10-meter walk test (10 mWT): Gait Speed

To identify the functional mobility and gait of an older individual, a 10 mWT (Bohannon et al., 1996) is found to be effective and will be adopted for the study.

Gait speed and distracted gait speeds: during walking 10 meter at a usual or comfortable pace as well as engage in a secondary visuospatial task while they walk at a usual or comfortable pace.

  • iii. Fall-related self-efficacy

Tool 1: Tinetti FES

Tinetti FES (Tinetti et al., 1990), is a standardized instrument used to determine the level of fear about fall among older adults.

  • iv. QoL

Tool 1: WHOQOL-OLD tool

A standardized instrument developed by WHO to assess the QoL among older adults (Power et al., 2005).

Phase II: Interview guide

The in-depth interview (IDI) guide for the qual strand of the study will be prepared by the researcher and finalized after validation by experts. The main lead question is to describe the experience of older adults in undergoing CCBTS in improving or not improving fall-related self-efficacy and QoL.

Ethical considerations

As the present study involves human participants, the researcher ensures that it will follow all the ethical principles laid down by the World Medical Association (WMA) as the Declaration of Helsinki (World Medical Association, 2013). Hence, the researcher will ensure that there is no breach of rights of participants during the conduct of the study.

Approval: The study was approved by Kasturba Medical College and Kasturba Hospital, Manipal ethics committee on March 2016 (IEC 130/2016).

Administrative permissions: Permissions to conduct the study will be obtained from the Head of the institutions, and the administrators of the care home who will permit to conduct the study.

Trial registration: This study is registered with The Clinical Trials Registry - India (CTRI);CTRI reference ID: CTRI/2016/11/007449; registered on 08/11/2016.Complete study information will be given to the participants through the ‘Participants Information Sheet’ and written informed consent will be obtained from the participants who are willing to participate in the study. The data monitoring committee from the IEC will monitor the adverse events, protocol deviations, and trial conduct.

Plan for data analysis

Phase I QUAN data will be analysed using SPSS version 15 (SPSS, RRID:SCR_002865) after entering the coded data into the software. Only the research team will have access to the stored data in the password protected personal computer of the researcher. Descriptive statistics will be used for analysing sample characteristics. Inferential statistics like Chi Square, and repeated measures of ANOVA will be used to measure the outcome variables within and between the groups. Intention to treat analysis and per protocol analysis will be computed as per the data availability and missing data. Phase II qual data will be analysed using TA with NVivo 12 software (NVivo, RRID:SCR_014802) using the institutional subscription.

Dissemination

The research team has planned to disseminate the findings of the study through various national and international geriatric domain specific scientific conference presentations. Team has also planned to publish two scientific papers from the study findings in peer-reviewed, indexed, international journals and institutional repository. The significant study findings will also be discussed with various stakeholders, NGOs and institutional administrators to enhance QoL at care homes.

Study status

Ongoing study is closed for participant recruitment and follow-up is going on with the study participants (both experimental and control arm). Second phase qualitative strand data collection is ongoing.

Discussion

Population aging is a demographic phenomenon faced by many countries across the globe at a different pace. India is one of the fastest aging regions both in low- and middle-income countries (LMICs) and in the world. However, the impact of an aging population is more or less the same across all regions (Rechel et al., 2009). The health trend among the older population is very unique, as in, some regions there is a declining trend in severe disabilities whereas in some other regions there is an increasing trend (Oliver et al., 2014). The pace with which age-related changes appear among the older population is also not the same among older people. While dealing with older adults it is essential to understand the common age-related normal changes among them. Out of all age-related changes among the older population, cognitive and physical decline have a major impact among older individuals (Harada et al., 2013). During the process of normal aging, cognitive abilities such as processing speed, attention, visuospatial abilities, executive functioning, conceptual reasoning, and memory decline gradually over time. However, the changes are not homogenous among older adults (Deary et al., 2009). This normal cognitive aging or age-related decline in cognitive abilities will eventually make older adults at high risk for impaired dual tasking and subsequently putting them at risk for fall and fall-related injuries (Hedden & Gabrieli, 2004). Thus, every attempt was made to enhance the cognitive abilities of older adults by engaging them in cognitive retraining so as to build their cognitive reserve. One way this will help them to be cognitively active and the other way it should aim at preventing the consequences of cognitive decline, balance, and gait issues among them (Salthouse, 2012; Salthouse, 2010). The present study protocol is also addressing the major concern of the geriatric population, the cognitive decline. In this study the researcher intends to identify the effect of cognitive training in gait speed, balance, fall-related self-efficacy and to enhance QoL among older adults.

Age-related decline in physical activity is another important contributing factor towards the issue pertaining to mobility and balance among the aging population. Due to a decrease in muscle mass and strength, the geriatric population experiences nearly 40-60% decline in their physical activity (Gregory et al., 2013). Hence, there is an increased likelihood of issues related to impaired physical activity such as balance issues, gait abnormalities, and fall-related injuries among older adults (Gopinath et al., 2018; Notthoff et al., 2017; Taylor, 2014; Virlando Suryadinata et al., 2020). Studies have even proved that if anyone is physically active, their momentum of cognitive decline would be very slow when compared with ones who are physically inactive. It is also proven that if a person is physically and cognitively active it will have a positive impact on their physical, emotional, and social well-being, hence aiding to a better QoL (Gill et al., 2013). With the present study, the researcher is addressing another important aspect of older adults, the physical decline by employing the muscle strength and balance training through various exercises for the institutionalized older adults.

Accordingly, the main focus of research studies in the field of geriatric medicine and gerontological nursing is to overcome the undesirable impacts of age-related changes and to enhance the overall wellbeing among the geriatric population (Gardette et al., 2007). A systematic review was conducted by Cadore et al., (2013) to determine the impact of various exercises on fall risk, gait, and balance issues among older adults. The review includes various exercise regimens like multi-component exercise program, resistance, endurance and balance training exercises. Results of the review summarised that, out of 10 trials seven found less fall-incidence, out of 11 trails six of them revealed a better gait stability, and seven out of 10 trials showed an enhancement in balance among older adults. The review concluded that the physical training by means of multicomponent exercise regimen is found to be effective in improving physical abilities among the older population. A systematic review of RCTs conducted by de Labra et al., (2015) on exercise interventions among older adults recommended that for improving the executive functionality of older people, physical training with targeted cognitive training would be better as it has got greater impact than physical and cognitive training alone. Out of multiple studies carried out among older adults to improve gait and balance as well as to prevent fall, the majority of them are either with physical exercise interventions executed separately and it often is not combined with cognitive training. Rather than an isolated implementation of cognitive or physical training, a combination of both is assumed be significantly beneficial in improving the walking and cognitive functionality among older people. Therefore, the researchers are interested in evaluating the combined effect of cognitive and balance training among older people in terms of gait, balance, and fall-related self-efficacy, which are all very common age-related issues among the geriatric population, and eventually to enhance their QoL.

Conclusions

Being the second most populous region in the world, ‘population aging’ the demographic phenomenon is more prominent in India and the issues and concerns related to the older population are also increasing over time. Amongst all the normal age-related changes among older people, cognitive decline and physical dependence are the most common and significant concern in the field of geriatrics. However, it would be better to treat both cognitive decline and physical strength as one component rather than treating it separately, as they complement each other and then there would be a better positive result. If the combination of physical and cognitive training is found to be effective in improving the gait, balance, and QoL among older individuals, it could be proposed to be implemented in all care homes by sensitizing various stake holders for effective implementation of such training program among older adults.

Data availability

Underlying data

No data are associated with this article.

Extended data

Figshare: PERSONAL PROFILE.docx (tool to collect sample characteristics and demographic profile). https://doi.org/10.6084/m9.figshare.19494506 (Assariparambil et al., 2022a).

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Reporting guidelines

Figshare: SPIRIT checklist for ‘Effectiveness of comprehensive cognitive and balance training strategies (CCBTS) on gait, balance, quality of life, and fall-related self-efficacy among institutionalized elderly in Udupi District: A mixed-method study protocol’. https://doi.org/10.6084/m9.figshare.19497503 (Assariparambil et al., 2022b).

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Competing interests

No competing interests were disclosed.

Grant information

The author(s) declared that no grants were involved in supporting this work.

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Assariparambil AR, Noronha JA and George A. Effectiveness of comprehensive cognitive and balance training strategies (CCBTS) on gait, balance, quality of life, and fall-related self-efficacy among institutionalized elderly in Udupi District: A mixed-method study protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:460 (https://doi.org/10.12688/f1000research.110462.1)
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Ragab K. Elnaggar, Cairo University, Giza, Giza Governorate, Egypt;  Prince Sattam bin Abdulaziz University, Al Kharj, Riyadh Province, Saudi Arabia 
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HOW TO CITE THIS REPORT
Elnaggar RK. Reviewer Report For: Effectiveness of comprehensive cognitive and balance training strategies (CCBTS) on gait, balance, quality of life, and fall-related self-efficacy among institutionalized elderly in Udupi District: A mixed-method study protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:460 (https://doi.org/10.5256/f1000research.122073.r179174)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 20 Feb 2023
Bart Visser, Centre of Expertise Urban Vitality, Faculty of Health, Amsterdam University of Applied Sciences, Amsterdam, The Netherlands 
Approved with Reservations
VIEWS 12
The paper describes a protocol for a mixed-method study. The quantitative part focus on the additional value of cognitive training to balance training and is set-up as randomised clinical trial (RCT). The qualitative part has a focus on the experiences ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Visser B. Reviewer Report For: Effectiveness of comprehensive cognitive and balance training strategies (CCBTS) on gait, balance, quality of life, and fall-related self-efficacy among institutionalized elderly in Udupi District: A mixed-method study protocol [version 1; peer review: 2 approved with reservations]. F1000Research 2022, 11:460 (https://doi.org/10.5256/f1000research.122073.r161518)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 26 Apr 2022
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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