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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 31, 2019

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Exercise
    • Walking football exercise program

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 50 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universidade do Porto
  • Collaborator
    • Federação Portuguesa de Futebol, Portugal
  • Provider of Information About this Clinical Study
    • Principal Investigator: Romeu Mendes, Researcher – Universidade do Porto
  • Overall Official(s)
    • Romeu Mendes, MD, PhD, Principal Investigator, EPIUnit – Instituto de Saúde Pública, Universidade do Porto

References

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.

Citations Reporting on Results

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. Book of Abstracts of the 24th Annual Congress of the European College of Sport Science. Prague: ECSS; 2019. p. 120-1.

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: University of Southern University; 2019. p. 41.

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 – Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 39.

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