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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03810846
Enrollment
40
Registered
2019-01-22
Start date
2018-09-17
Completion date
2019-06-30
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Exercise, Physical Activity, Football, Walking Football, Type 2 Diabetes, Primary Health Care, Feasibility, Safety

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.

Interventions

BEHAVIORALWalking 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.

Sponsors

Federação Portuguesa de Futebol, Portugal
CollaboratorUNKNOWN
Administração Regional de Saúde do Norte, Portugal
CollaboratorOTHER
Fédération Internationale de Football Association
CollaboratorUNKNOWN
Universidade do Porto
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
50 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Exercise intensity - subjective internal loadThrough 3 monthsOMNI rating of perceived exertion scale during exercise (0 \[lowest\] to 10 \[highest\] points)
Exercise intensity - objective internal loadThrough 3 monthsHeart rate during exercise
Exercise intensity - external loadThrough 3 monthsDistance (km) assessed using GPS tracking during exercise
Acute glycemic effectChange between before and immediately after each exercise sessionAcute change in capillary blood glucose with exercise sessions
Acute systolic blood pressure effectChange between before and immediately after each exercise sessionAcute change in systolic blood pressure with exercise sessions
Rate of EnjoymentThrough 3 monthsSelf-reported exercise sessions' enjoyment on a likert scale (1 \[lowest\] to 5 \[highest\] points)
Acute diastolic blood pressure effectChange between before and immediately after each exercise sessionAcute change in diastolic blood pressure with exercise sessions
Incidence of fallsThrough 3 monthsNumber of falls during the exercise program
Incidence of foot injuriesThrough 3 monthsNumber of reported foot injuries during the exercise program
Incidence of musculoskeletal injuriesThrough 3 monthsNumber of reported musculoskeletal injuries during the exercise program

Secondary

MeasureTime frameDescription
Food patternChange from baseline to 3 months24h-food recall analysis
Cognitive stateChange from baseline to 3 monthsMontreal Cognitive Assessment score (0 \[lowest\] to 30 \[highest\] points)
Agility/balanceChange from baseline to 3 monthsTimed Up and Go Test
MedicationChange from baseline to 3 monthsNumber of medications
Health-related quality of lifeChange from baseline to 3 monthsEQ-5D-5L questionnaire score (0 \[lowest\] to 100 \[highest\] points)
Glycemic controlChange from baseline to 3 monthsGlycated hemoglobin (venous blood analysis)
Blood lipid profileChange from baseline to 3 monthsTotal cholesterol (venous blood analysis)
Clinical systolic blood pressureChange from baseline to 3 monthsResting systolic blood pressure
Clinical diastolic blood pressureChange from baseline to 3 monthsResting diastolic blood pressure
Body mass indexChange from baseline to 3 monthsBody mass index
Waist circumferenceChange from baseline to 3 monthsWaist circumference
Body fatChange from baseline to 3 monthsBody fat (bioelectrical impedance analysis)
Body lean massChange from baseline to 3 monthsBody lean mass (bioelectrical impedance analysis)
Habitual physical activityChange from baseline to 3 monthsGlobal Physical Activity Questionnaire

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026