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Completed

NCT Number: NCT03810846

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

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.

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Key information

Age range

50 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Saúde Pública da Universidade do Porto

Porto, 4050-600, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Walking football exercise program

Behavioral

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.

Primary outcomes

  1. Exercise intensity - subjective internal load

    Time frame: Through 3 months

    OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)

  2. Exercise intensity - objective internal load

    Time frame: Through 3 months

    Heart rate during exercise

  3. Exercise intensity - external load

    Time frame: Through 3 months

    Distance (km) assessed using GPS tracking during exercise

  4. Acute glycemic effect

    Time frame: Change between before and immediately after each exercise session

    Acute change in capillary blood glucose with exercise sessions

  5. 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

  6. 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

  7. Incidence of falls

    Time frame: Through 3 months

    Number of falls during the exercise program

  8. Incidence of foot injuries

    Time frame: Through 3 months

    Number of reported foot injuries during the exercise program

  9. Incidence of musculoskeletal injuries

    Time frame: Through 3 months

    Number of reported musculoskeletal injuries during the exercise program

  10. Rate of Enjoyment

    Time frame: Through 3 months

    Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)

Secondary outcomes

  1. Glycemic control

    Time frame: Change from baseline to 3 months

    Glycated hemoglobin (venous blood analysis)

  2. Blood lipid profile

    Time frame: Change from baseline to 3 months

    Total cholesterol (venous blood analysis)

  3. Clinical systolic blood pressure

    Time frame: Change from baseline to 3 months

    Resting systolic blood pressure

  4. Clinical diastolic blood pressure

    Time frame: Change from baseline to 3 months

    Resting diastolic blood pressure

  5. Body mass index

    Time frame: Change from baseline to 3 months

    Body mass index

  6. Waist circumference

    Time frame: Change from baseline to 3 months

    Waist circumference

  7. Body fat

    Time frame: Change from baseline to 3 months

    Body fat (bioelectrical impedance analysis)

  8. Body lean mass

    Time frame: Change from baseline to 3 months

    Body lean mass (bioelectrical impedance analysis)

  9. Agility/balance

    Time frame: Change from baseline to 3 months

    Timed Up and Go Test

  10. Habitual physical activity

    Time frame: Change from baseline to 3 months

    Global Physical Activity Questionnaire

  11. Food pattern

    Time frame: Change from baseline to 3 months

    24h-food recall analysis

  12. Cognitive state

    Time frame: Change from baseline to 3 months

    Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)

  13. Health-related quality of life

    Time frame: Change from baseline to 3 months

    EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)

  14. Medication

    Time frame: Change from baseline to 3 months

    Number of medications

Sponsors and collaborators

Lead sponsor

Universidade do Porto

Other

Collaborators

  • Administração Regional de Saúde do Norte, Portugal
  • Fédération Internationale de Football Association
  • Portuguese Football Federation

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Aug 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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