Instituto de Saúde Pública da Universidade do Porto
Porto, 4050-600, Portugal
NCT Number: NCT03810846
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.
Looking for future studies?
Notify Me50 year–70 year
Male
Interventional
Not applicable
Porto, 4050-600, Portugal
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Through 3 months
OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
Time frame: Through 3 months
Heart rate during exercise
Time frame: Through 3 months
Distance (km) assessed using GPS tracking during exercise
Time frame: Change between before and immediately after each exercise session
Acute change in capillary blood glucose with exercise sessions
Time frame: Change between before and immediately after each exercise session
Acute change in systolic blood pressure with exercise sessions
Time frame: Change between before and immediately after each exercise session
Acute change in diastolic blood pressure with exercise sessions
Time frame: Through 3 months
Number of falls during the exercise program
Time frame: Through 3 months
Number of reported foot injuries during the exercise program
Time frame: Through 3 months
Number of reported musculoskeletal injuries during the exercise program
Time frame: Through 3 months
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
Time frame: Change from baseline to 3 months
Glycated hemoglobin (venous blood analysis)
Time frame: Change from baseline to 3 months
Total cholesterol (venous blood analysis)
Time frame: Change from baseline to 3 months
Resting systolic blood pressure
Time frame: Change from baseline to 3 months
Resting diastolic blood pressure
Time frame: Change from baseline to 3 months
Body mass index
Time frame: Change from baseline to 3 months
Waist circumference
Time frame: Change from baseline to 3 months
Body fat (bioelectrical impedance analysis)
Time frame: Change from baseline to 3 months
Body lean mass (bioelectrical impedance analysis)
Time frame: Change from baseline to 3 months
Timed Up and Go Test
Time frame: Change from baseline to 3 months
Global Physical Activity Questionnaire
Time frame: Change from baseline to 3 months
24h-food recall analysis
Time frame: Change from baseline to 3 months
Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
Time frame: Change from baseline to 3 months
EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
Time frame: Change from baseline to 3 months
Number of medications
Universidade do Porto
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05108987
Behavior, Diabetes Mellitus
New Brunswick, New Jersey, United States
View Trial DetailsNCT03133156
Behavior, Body Weight
Boston, Massachusetts, United States
View Trial DetailsNCT03709966
Behavior, Diabetes Mellitus
Québec, Quebec, Canada
View Trial DetailsNCT03534687
Alzheimer Disease 10, Behavior
Ann Arbor, Michigan, United States
View Trial Details