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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810846
• Other study ID #: ISPUP-RMFIFA2018
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2019
• Source: Universidade do Porto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Walking football exercise program
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.

Locations

Country	Name	City	State
Portugal	Instituto de Saúde Pública da Universidade do Porto	Porto

Sponsors (4)

Lead Sponsor	Collaborator
Universidade do Porto	Administração Regional de Saúde do Norte, Portugal, Federação Portuguesa de Futebol, Portugal, Fédération Internationale de Football Association

Country where clinical trial is conducted

Portugal, 

References & Publications (4)

Barbosa A, Brito J, Costa J, Ramos E, Firmino-Machado J, Seabra A, Figueiredo P, Sá MJ, Lunet N, Mendes R. SWEET-FOOTBALL: Development of an evidence-based walking football program for middle-aged and older patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 32.

Barbosa A, Brito J, Sá MJ, Puga F, Firmino-Machado J, Seabra A, Figueiredo P, Ramos E, Lunet N, Mendes R. Adherence and enjoyment of a walking-football program for patients with type 2 diabetes: SWEET-FOOTBALL Project. In: Bunc V, Tsolakidis E, editors. B

Costa J, Brito J, Barbosa A, Figueiredo P, Seabra A, Sá MJ, Firmino-Machado J, Ramos E, Mendes R. Nocturnal cardiac autonomic activity in patients with type 2 diabetes engaged in a walking football programme. Football is Medicine Conference 2019 - Program

Rago V, Brito J, Costa J, Barbosa A, Figueiredo P, Seabra A, Travassos B, Mendes R. Activity profile during walking football training sessions in patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: Univer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise intensity - subjective internal load	OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)	Through 3 months
Primary	Exercise intensity - objective internal load	Heart rate during exercise	Through 3 months
Primary	Exercise intensity - external load	Distance (km) assessed using GPS tracking during exercise	Through 3 months
Primary	Acute glycemic effect	Acute change in capillary blood glucose with exercise sessions	Change between before and immediately after each exercise session
Primary	Acute systolic blood pressure effect	Acute change in systolic blood pressure with exercise sessions	Change between before and immediately after each exercise session
Primary	Acute diastolic blood pressure effect	Acute change in diastolic blood pressure with exercise sessions	Change between before and immediately after each exercise session
Primary	Incidence of falls	Number of falls during the exercise program	Through 3 months
Primary	Incidence of foot injuries	Number of reported foot injuries during the exercise program	Through 3 months
Primary	Incidence of musculoskeletal injuries	Number of reported musculoskeletal injuries during the exercise program	Through 3 months
Primary	Rate of Enjoyment	Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)	Through 3 months
Secondary	Glycemic control	Glycated hemoglobin (venous blood analysis)	Change from baseline to 3 months
Secondary	Blood lipid profile	Total cholesterol (venous blood analysis)	Change from baseline to 3 months
Secondary	Clinical systolic blood pressure	Resting systolic blood pressure	Change from baseline to 3 months
Secondary	Clinical diastolic blood pressure	Resting diastolic blood pressure	Change from baseline to 3 months
Secondary	Body mass index	Body mass index	Change from baseline to 3 months
Secondary	Waist circumference	Waist circumference	Change from baseline to 3 months
Secondary	Body fat	Body fat (bioelectrical impedance analysis)	Change from baseline to 3 months
Secondary	Body lean mass	Body lean mass (bioelectrical impedance analysis)	Change from baseline to 3 months
Secondary	Agility/balance	Timed Up and Go Test	Change from baseline to 3 months
Secondary	Habitual physical activity	Global Physical Activity Questionnaire	Change from baseline to 3 months
Secondary	Food pattern	24h-food recall analysis	Change from baseline to 3 months
Secondary	Cognitive state	Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)	Change from baseline to 3 months
Secondary	Health-related quality of life	EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)	Change from baseline to 3 months
Secondary	Medication	Number of medications	Change from baseline to 3 months