Keywords
Exercise Therapy, Diabetes Mellitus, Type 2, Sports for Persons with Disabilities, Treatment Adherence and Compliance, Metabolism, Quality of Life, team handball training, team sports
Type 2 diabetes mellitus (T2DM) is recognized as a serious public health concern with a considerable impact on people suffering from the disease and the society. The benefit of physical activity in the prevention and treatment of T2DM are well documented, however, a considerable proportion of individuals with T2DM have an inactive and sedentary lifestyle. Although most people with T2DM are aware of the importance of exercise, many are not interested in joining traditional exercise options, and long-term adherence is poor for those who do. Thus, we aim to investigate the feasibility of recreational handball-based training (HBT) for people diagnosed with T2DM.
This single-arm feasibility trial included adults (over 30 years) with a clinical diagnosis of T2DM. They were invited to participate in a 12-week HBT consisting of two weekly 60-minute exercise sessions. The outcome was feasibility, determined by adherence, exercise intensity, adverse events, dropout rate, and metabolic parameters.
From September to December 2021, 10 people were included in the study. One participant dropped out because of illness and one participant dropped out due to suspected atrial fibrillation. Eight participants concluded the intervention and participated on average 86% (range 14–23) of the HBT sessions exercising with a mean heart rate of 73.4% (standard deviation (SD) 10.2) of individual maximum heart rate.
HBT for people diagnosed with T2DM was found feasible with a high attendance rate and clinically relevant exercise intensities. However, future randomized controlled trials about the effects of the handball intervention are needed.
This trial was registered in ClinicalTrials.gov (NCT05015946) on 23/08/2021.
Exercise Therapy, Diabetes Mellitus, Type 2, Sports for Persons with Disabilities, Treatment Adherence and Compliance, Metabolism, Quality of Life, team handball training, team sports
Type 2 diabetes mellitus (T2DM) is recognized as a public health concern, in 2021 it was estimated that 537 million adults are living with diabetes.1 T2DM is associated with severe complications such as retinopathy, nephropathy, neuropathy, and ultimately premature mortality primarily due to cardiovascular events,2 and 35% of people with T2DM experience complications even before the time of diagnosis.3 As a consequence, T2DM influence individuals’ functional capacity and quality of life.4
The benefit of physical activity and exercise in the prevention and control of T2DM and its complications are well documented,5,6 and is a cornerstone in the first-line treatment. However, a considerable proportion of people with T2DM are inactive and have a sedentary lifestyle and do not adhere to clinical recommendations.7,8 Although most people with T2DM recognize the importance of exercise, many are not interested in joining formal, structured exercise programs and long-term adherence is poor for those who do.9 Thus, a need for new exercise opportunities that can effectively improve diabetes health, while endorsing high levels of motivation to ensure long-term adherence is needed.
During the recent decades, there has been an increased interest in practicing adapted recreational team sports in the treatment and control of noncommunicable diseases.10 There are indications, that team sport is motivating for a sedentary population,11–13 and may promote internal motivation which is a strong predictor of fidelity and adherence.11 Most research in the field of recreational team sport has been conducted with a soccer-based intervention, however, recreational handball show similar demands to those described for recreational soccer.14,15 Former trials show15–20 that recreational team handball for untrained adult men and women is an intermittent high-intensity exercise mode in the range of those found to have a positive effect on aerobic, anaerobic and musculoskeletal fitness in adult individuals. Furthermore, the exercise intensity was unaffected by past experience with handball or other sports.19 A 16-week recreational team handball intervention for 67 postmenopausal women with no experience with the sport, found that handball produced moderate-to-vigorous aerobic intensities and two weekly 60 minutes handball sessions resulted in 10% improvements in cardiorespiratory performance.21 However, the feasibility of handball in a clinical population has yet to be investigated.
This trial was conducted according to the declaration of Helsinki and approved by the North Denmark Region Committee on Health Research Ethics (registration number N-20200006) on 17/06/2020. Participants provided written informed consent prior to baseline assessment.
This trial was registered in ClinicalTrials.gov identifier: NCT05015946. Registration date: 23/08/2021.
People older than 30 years with a clinical diagnosis of T2DM were eligible for inclusion. Potential participants who were prohibited by their general practitioner from participation in HBT were excluded. The local Diabetes Association in the municipality of Aalborg recruited study participants by advertising in their membership magazines.
The intervention was delivered in an indoor municipal sports arena and consisted of 12 weeks of recreational HBT with two 60 minutes sessions per week. Each session included 1) 20 minutes of standardized warm-up, 2) 20 minutes of handball specific exercises and 3) 20 minutes of small-sided matches. To avoid injuries, no hard tackles were allowed, and the handballs used were light and made of soft material. The intervention was facilitated by BHF, DA, TM and ERH as part of their physiotherapy bachelor project. The intervention is illustrated in Table 1.
Standard handball-based training session | |
---|---|
0–20 min | Standardized warm-up (comprising of running, strength training, coordination exercises, balance training, and flexibility exercises) based on the FIFA11+ concept,33 modified to handball and untrained individuals. |
21–40 min | Handball specific exercises (comprising running, jumping, throwing, and shooting on goals) |
41–60 min | Small-sided matches (mainly 4v4 or 5v5) with no permanent goalkeeper on a 20×13 meters court. |
Primary outcomes
The primary outcomes were feasibility of HBT, determined by adherence, adverse events, dropout rate, and the exercise intensity. Dropout was defined as individuals completing baseline tests but not the follow-up test. The exercise intensity was measured using heart rate (HR) monitors (Polar h10) at both sessions in week 2,7 and 12. Adverse events were recorded during the entire intervention period.
Further outcomes were change from baseline to 12 week on hemoglobin A1c (HbA1c) (HemoCue HbA1c 501), physical (PCSc) and mental health component (MCSc) measured with the Short Form 36 (SF36)22 and cardiovascular fitness measured with peak oxygen uptake (VO2peak) during an incremental cycling test following a standard protocol. A bike ergometer (Corival Lode, Groningen, The Netherlands) was used with a direct measurement of oxygen consumption by breath-by-breath on Jaeger Masterscreen CPX (Intramedic A/S, Lyngby, Denmark).
Secondary outcomes
Secondary outcome measures were change from baseline to 12 week on self-care behavior measured with Diabetes Intention, Attitude and Behavior Questionnaire (DIAB-Q)23 and physical activity levels measured with Physical Activity Scale 2 (PAS2),24 cholesterol (total, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglyceride (TG) (Accutrend Plus Cholesterol Meter), body composition (body mass index (BMI), body fat, lean body mass) (Tanita MC-180MA, Tokyo, Japan), visceral adipose tissue (hip/waist ratio) and resting blood pressure (Omron, M4-I).
After arriving at the test facility, the participants were informed about the procedure of the tests performed. Afterward, they were asked to rest for 10 min in a sitting position before applying the cuff on the left arm. Three measures were taken using an automatic blood pressure monitor and the lowest value of both diastolic and systolic blood pressure was used for calculations. HbA1c and cholesterol (total, LDL, TG, and HDL) were measured using a capillary blood sample. The fingertip was first disinfected. Then, blood was collected for both HbA1c and cholesterol. To measure waist circumference a standard measuring tape was placed between the lowest rib and the upper iliac crest after a normal exhalation. To find the hip circumference the measuring tape was placed at the widest part of the hip. A Tanita® digital scale with bioelectrical impedance was used to measure weight and body fat. The participants stepped barefooted onto the scale and were instructed to keep the handgrips slightly elevated from the torso. The VO2peak test was initiated with a 5-min warm-up period on 50 watts, followed by a 25-watt increase per minute until exhaustion. The test was considered a VO2max test if the respiratory exchange ratio (RER) value exceeded 1.10 and the O2-consumption reached a plateau. Otherwise, it was categorized as a VO2peak test.
Adherence was defined as the percentage of training sessions attended of the scheduled 24 sessions. Exercise intensities were merged into three timepoints by calculating the mean of the two weekly sessions in week 2, 7 and 12. Percent of heartrate maximum (HRmax) was calculated using an estimated maximum heart rate 25 Statistics on adherence and intensities were conducted in Microsoft Excel (version 2302, Office 365). Results in within-group changes from baseline to 12 weeks are presented as median with minimum/maximum and analyzed using the Wilcoxon-rank test in SPSS (IBM SPSS Statistics 27) (RRID:SCR_002865). Statistical significance was set at p<0.05.
In September 2021, 15 interested people with T2DM were recruited and screened for eligibility. Two were diagnosed with Type 1 diabetes, and one was under 30 years old and thereby not eligible for inclusion. Two decided not to participate due to time and transportation. In total, 10 participants were included. During the intervention, one participant dropped out due to illness not related to the intervention, and one participant stopped due to suspected atrial fibrillation detected in the baseline assessment. Eight participants contributed with follow-up data. A study flowchart is presented in Figure 1 and participants’ characteristics at baseline in Table 2.
The eight participants attended a mean of 20 (range 14–23) of 24 training sessions, corresponding to an attendance rate of 83%. Mean HR during HBT, based on six training sessions in weeks 2, 7 and 12, was 121.3 beats per minute (standard deviation (SD) 17) corresponding to 73.4% (SD 10.2) of individual maximal HR. Time spent with a HR over 70% was 61.1% (SD 30.1), and time spent in the intensity zones 70–80%, 80–90% and 90–100% was 31.9% (SD 18.5), 21.6% (SD16.1) and 7.6% (SD 10.6) of total training time, respectively. The mean % of maximal HR in the first 20 minutes (warm-up) was 65.5% (SD 6.5), the middle 20 minutes (handball specific) was 74.8% (SD 8.4) and the last 20 minutes (matches) was 79.4% (SD 10.2). Individual peak HR was 130 bpm (SD 4.7) corresponding to 89.6% of HRmax (SD 2.9) measured in week 12. Mean exercise intensities are displayed in Table 3 and individual exercise intensities with one-minute frequency for all participants is illustrated in Figure 2a–f.
Percent of individual maximal heart rate during training sessions | ||||
---|---|---|---|---|
0–20 minute | 21–40 minute | 41–60 minutes | 0–60 minute | |
Mean | 66 | 75 | 80 | 73 |
SD | 7 | 8 | 10 | 10 |
Percent of individual maximal heart rate during intervention period | |||
---|---|---|---|
Week 2 | Week 7 | Week 12 | |
Mean | 71 | 71 | 78 |
SD | 11 | 9 | 8 |
Percent in intensity zones | ||||
---|---|---|---|---|
>70% HRmax | 70–80% HRmax | 80–90% HRmax | 90–100% HRmax | |
Mean | 61 | 32 | 22 | 8 |
SD | 30 | 18 | 16 | 11 |
HRmax, heart rate maximum; ID, identification.
There was no statistical change from baseline to 12 weeks for HbA1c (p=0.14), VO2peak (p=0.4) or physical (p=0.11), and mental health (p=0.48). From baseline to follow-up there was a small increase in total cholesterol (p=0.09) mediated by an increase in LDL (p=0.02). There was a drop in body fat mass (p=0.04) and BMI (0.02) but no change in visceral fat (p=0.24). We found no change in systolic blood (p=0.54) pressure but a significant drop in diastolic (p=0.04) blood pressure. Lastly there were no changes in the participant’s physical activity levels (p=0.45) but higher levels of engagement in beneficial behaviors (p=0.03). All baseline to 12-week measures are displayed in Table 4.
No serious adverse events were detected. Two times a participant fell involuntarily during the training session but continued and finalized the sessions. One participant experienced a muscle strain and resumed handball training after a one-week rest period. There were no episodes with exercise induced hypoglycemia.
Recreational HBT was found feasible for people diagnosed with T2DM with high attendance rate and moderate to high exercise intensities. The HR recordings showed an average HR of 73% (SD 10.2) and almost 30% of the time with an HR above 80% of HRmax. These values are in line with those found in non-clinical inactive postmenopausal women playing recreational handball by Pereira et al.21 They reported a mean HRmax at 76% (SD 6), however duration above 80% of HRmax at 44% (SD 20) of the time which is higher than those found in the present study. This may be explained by the differences between the interventions, as they only measured exercise intensities during small-sided matches.21 The last part of the present intervention did produce the highest exercise intensities among the participants with a mean HR at almost 80% of HRmax and more than 45% (SD 37) of the time intensities above 80% of HRmax. Andersen et al.26 reported mean intensities at 82% of HRmax and almost 65% of total playing time with intensities above 80% of HRmax, among men diagnosed with T2DM playing small-sided football. The explanation for this may be that their participants were younger (mean 50.6, SD 7.1) compared to the present study and that they excluded people with co-morbidities and diabetic complaints that might reduce the potential of playing football with high intensities.26
The present study was not powered to detect significant changes in effects. However, there was a tendency towards improvement in most of the outcomes assessed. Previous studies investigating football in women and men with T2DM reported improvements of 10% after 12 and 24 weeks in VO2peak26,27 working at similar exercise intensities as in the present study. Similar results are found in studies investigating recreational handball in different populations16,21,28 suggesting that HBT for people with T2DM may be an effective way to improve cardiovascular function. The potential effect of recreational team sport in reducing HbA1c is under-investigated, however, exercise in general especially with higher intensities has been found to substantially decrease HbA1c levels in people with T2DM.29 Furthermore, team sport has been found effective to increase the quality of life and instinct motivation,30,31 which are important predictor of long-term adherence and fidelity.11
No serious adverse events occurred during the handball-based training which is in concordance with previous studies.17,20,21 Only one case of muscle injury happened and was managed conservatively. Few episodes with involuntary falls occurred, however, these falls did not cause any injury that prevented the participants from continuing the training. These falls may be a source of great concern and the presence of diabetes complications such as retinopathy and neuropathy may place people with T2DM at a greater risk of falling. Compared to non-clinical populations engaging in handball training, the present study did not report more cases of adverse events.17,20,21 This may be explained by the difference in the intervention as former study interventions only include small-sided matches, which only represented the last third part of present HBT. Furthermore, the present intervention included 20 minutes of warm-up comprising running, strength training, coordination exercises, balance training, and flexibility exercises followed by 20 minutes of handball skill training, which may reduce the risk of adverse events occurring during matches.
Some deviations from the registration in ClinicalTrials.gov were made. Since the current trial is a feasibility trial, we changed our primary outcomes reported in ClinicalTrials.gov to feasibility outcomes and listed all effectiveness outcomes as secondary outcomes. Furthermore, we planned an aerobic endurance test, however this test was not completed as it was too demanding according to the participants’ physical condition.
The recruitment rate was lower than expected and there was a possibility of selection bias, as the present study appealed to participants motivated for handball. Participants were asked to stay on their current medical prescription and change in medicine may affect some outcome of interest. When reporting exercise intensities in warm-up, handball-specific exercises, and small-sided matches the categorization may not represent the actual content of the training session due to the pragmatic delivery of the intervention. Consequently, some overlap between the three parts is expected to be present. All assessments were pre-defined and the assessment of clinically relevant outcomes was conducted using validated instruments.
For patients with T2DM, adherence and fidelity to prescribed exercise are highly important. In the present study we observed a high attendance rate (>80%) and clinically relevant training intensities. Additionally, it is notable that HBT can be played without prior experience with handball and can be played with a limited number of participants. Furthermore, small-sided matches were played at a 13×20 meters indoor court which allows three of these to fit on a regular handball court, and thereby the possibility of triple the number of participants. Thus, HBT may be attractive and easily accessible for people with T2DM. The present study’s feasibility findings and preliminary results indicate that future studies need to investigate the efficacy and effectiveness of HBT for people with T2DM in randomized controlled designs.
HBT was feasible for people with T2DM. The present study observed a high attendance rate of 83% and a mean training intensity of almost 75% of HRmax. More than 60% of the time participant trained with an intensity of 70-100% of HRmax. The highest training intensity was found during small-sided matches, with a mean at 80% of HRmax. Future randomized controlled trials are needed to determine the effect of HBT.
Martin Færch Andersen: Conceptualization, methodological inputs, project administration, intervention delivery, data collection, formal analysis, funding acquisition, writing the first draft, commenting in rounds of revision (lead), approved the final draft.
Allan Riis: conceptualization, methodological inputs, writing the first draft, commenting in rounds of revision, approved the final draft.
Henrik Foged Borup: Intervention delivery, methodological inputs, commenting in rounds of revision, approved the final version.
Astrid Dall: Intervention delivery, methodological inputs, commenting in rounds of revision, approved the final version.
Mie Torp: Intervention delivery, methodological inputs, commenting in rounds of revision, approved the final version.
Rikke Hareskov Elversøe: Intervention delivery, methodological inputs, commenting in rounds of revision, approved the final version.
Janus Laust Thomsen: Methodological inputs, oversighting test procedures, commenting in rounds of revision, approved the final version.
Peter Vestergaard: Methodological inputs, commenting in rounds of revisions, approved the final draft.
Anne-Mette Lücke Dissing: Conceptualization, Methodological inputs, Data collection (lead), Formal analysis, commenting in rounds of revisions, approved the final draft.
Open Science Framework: Data repository: Recreational handball-based training for people with type 2 diabetes. https://doi.org/10.17605/OSF.IO/VZ6G5. 32
This project contains the following underlying data:
• dataset_pub.xlsx (Sheet 1, attendance: Individual participant (ID) attendance in two weekly training sessions for twelve weeks. X marks when participants attended a training session. Sheet 2-7, exercise intensity: Individual participant (ID) exercise intensity at both training sessions in week 2,7 and 12. First row indicate time (minutes), first column indicates participant (ID), data is reported as percentage of individual heart rate maximum.)
Open Science Framework: CONSORT extension for pilot and feasibility trials for ‘Recreational handball-based training for people with type 2 diabetes: a feasibility trial’. https://doi.org/10.17605/OSF.IO/VZ6G5. 32
Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).
We thank Vibeke Brinkmann Løite for her methodological contributions when planning this study.
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Is the work clearly and accurately presented and does it cite the current literature?
Partly
Is the study design appropriate and is the work technically sound?
Yes
Are sufficient details of methods and analysis provided to allow replication by others?
Yes
If applicable, is the statistical analysis and its interpretation appropriate?
Yes
Are all the source data underlying the results available to ensure full reproducibility?
Yes
Are the conclusions drawn adequately supported by the results?
Yes
Competing Interests: No competing interests were disclosed.
Reviewer Expertise: Rehabilitation, Physiotherapy
Alongside their report, reviewers assign a status to the article:
Invited Reviewers | |
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Version 1 07 Nov 23 |
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