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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Walking football exercise program

• Registration Number: NCT03810846
• Lead Sponsor: Universidade do Porto

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-09-17
• Study First Submitted: 2019-01-10
• Study First Submitted QC: 2019-01-16
• Study First Posted: 2019-01-22
• Primary Completion: 2019-01-31
• Study Completion: 2019-06-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-20
• Last Update Posted: 2019-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Exercise	Walking football exercise program	Walking football exercise program

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Saúde Pública da Universidade do Porto; 🇵🇹 Porto, Portugal