Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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Our main challenge is to develop a novel physical activity intervention to promote exercise participation sustainability and effective health benefits in type 2 diabetes (T2D) population with minimum health risks. The relevance of this study is supported by four cornerstones: 1) The Portuguese love football and there seems to be a major potential in the implementation of football practice as part of the prevention and treatment of noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies have assessed the feasibility and safety of a walking football exercise program for middle-age and older patients with T2D; 3) the proposed investigation relies on robust methodology; 4) this intervention can have further sustainability with the enrollment of football clubs and primary health care units.

Detailed Description
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This work will be a quasi-experimental study where we aim to test the feasibility and safety of walking football in patients with T2D. The recruitment of participants will be held in primary health care units by Family Medicine medical doctors. All participants will receive instructions to maintain daily-life routines (lifestyle-related physical activity and dietary pattern), and to continue with usual care (diabetes consultations on primary health care units and pharmacological regimen) along the studies duration. All participants will receive basic sports material (sports bag, T-shirt, and sports shoes). Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety (acute effects on capillary glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Cumulative short-term effects will also be analyzed along the three months through pre- and post-study evaluations. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.

Official Title
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Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: Walking football exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of type 2 diabetes for at least 12 months; glycated hemoglobin bellow 10 %; not having started insulin therapy in the previous six months; not having started therapy with sulfonylureas in the previous six months; major complications of diabetes screened and controlled (diabetic retinopathy, diabetic nephropathy and diabetic foot); no symptoms of coronary artery disease; no cardiovascular, respiratory and musculoskeletal contraindications to exercise; not under cancer treatment (radiotherapy or intravenous chemotherapy); without limitations in gait or balance; independent living in the community; not engaged in supervised exercise; non-smokers at least for 6 months. Exclusion Criteria: cardiological stress test with cardiac or hemodynamic problems

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Walking football exercise program | Behavioral: Walking football exercise program<br>* Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise intensity - subjective internal load | OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points) | Through 3 months | 
| Exercise intensity - objective internal load | Heart rate during exercise | Through 3 months | 
| Exercise intensity - external load | Distance (km) assessed using GPS tracking during exercise | Through 3 months | 
| Acute glycemic effect | Acute change in capillary blood glucose with exercise sessions | Change between before and immediately after each exercise session | 
| Acute systolic blood pressure effect | Acute change in systolic blood pressure with exercise sessions | Change between before and immediately after each exercise session | 
| Acute diastolic blood pressure effect | Acute change in diastolic blood pressure with exercise sessions | Change between before and immediately after each exercise session | 
| Incidence of falls | Number of falls during the exercise program | Through 3 months | 
| Incidence of foot injuries | Number of reported foot injuries during the exercise program | Through 3 months | 
| Incidence of musculoskeletal injuries | Number of reported musculoskeletal injuries during the exercise program | Through 3 months | 
| Rate of Enjoyment | Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points) | Through 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycemic control | Glycated hemoglobin (venous blood analysis) | Change from baseline to 3 months | 
| Blood lipid profile | Total cholesterol (venous blood analysis) | Change from baseline to 3 months | 
| Clinical systolic blood pressure | Resting systolic blood pressure | Change from baseline to 3 months | 
| Clinical diastolic blood pressure | Resting diastolic blood pressure | Change from baseline to 3 months | 
| Body mass index | Body mass index | Change from baseline to 3 months | 
| Waist circumference | Waist circumference | Change from baseline to 3 months | 
| Body fat | Body fat (bioelectrical impedance analysis) | Change from baseline to 3 months | 
| Body lean mass | Body lean mass (bioelectrical impedance analysis) | Change from baseline to 3 months | 
| Agility/balance | Timed Up and Go Test | Change from baseline to 3 months | 
| Habitual physical activity | Global Physical Activity Questionnaire | Change from baseline to 3 months | 
| Food pattern | 24h-food recall analysis | Change from baseline to 3 months | 
| Cognitive state | Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points) | Change from baseline to 3 months | 
| Health-related quality of life | EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points) | Change from baseline to 3 months | 
| Medication | Number of medications | Change from baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Physical Activity, Football, Walking Football, Type 2 Diabetes, Primary Health Care, Feasibility, Safety