Clinical trial NCT03810846: Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
Official title: Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Exercise
Physical Activity
Football
Walking Football
Type 2 Diabetes
Primary Health Care
Feasibility
Safety
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Federação Portuguesa de Futebol, Portugal
name: Administração Regional de Saúde do Norte, Portugal
name: Fédération Internationale de Football Association
First posted: 2019-01-22
Enrollment: 40
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exercise intensity - subjective internal load
timeFrame: Through 3 months
measure: Exercise intensity - objective internal load
timeFrame: Through 3 months
measure: Exercise intensity - external load
timeFrame: Through 3 months
measure: Acute glycemic effect
timeFrame: Change between before and immediately after each exercise session
measure: Acute systolic blood pressure effect
timeFrame: Change between before and immediately after each exercise session
measure: Acute diastolic blood pressure effect
timeFrame: Change between before and immediately after each exercise session
measure: Incidence of falls
timeFrame: Through 3 months
measure: Incidence of foot injuries
timeFrame: Through 3 months
measure: Incidence of musculoskeletal injuries
timeFrame: Through 3 months
measure: Rate of Enjoyment
timeFrame: Through 3 months
Secondary outcomes:
measure: Glycemic control
timeFrame: Change from baseline to 3 months
measure: Blood lipid profile
timeFrame: Change from baseline to 3 months
measure: Clinical systolic blood pressure
timeFrame: Change from baseline to 3 months
measure: Clinical diastolic blood pressure
timeFrame: Change from baseline to 3 months
measure: Body mass index
timeFrame: Change from baseline to 3 months
measure: Waist circumference
timeFrame: Change from baseline to 3 months
measure: Body fat
timeFrame: Change from baseline to 3 months
measure: Body lean mass
timeFrame: Change from baseline to 3 months
measure: Agility/balance
timeFrame: Change from baseline to 3 months
measure: Habitual physical activity
timeFrame: Change from baseline to 3 months
measure: Food pattern
timeFrame: Change from baseline to 3 months
measure: Cognitive state
timeFrame: Change from baseline to 3 months
measure: Health-related quality of life
timeFrame: Change from baseline to 3 months
measure: Medication
timeFrame: Change from baseline to 3 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Instituto de Saúde Pública da Universidade do Porto
Study officials:
affiliation: EPIUnit - Instituto de Saúde Pública, Universidade do Porto
name: Romeu Mendes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Barbosa A, Brito J, Costa J, Figueiredo P, Seabra A, Mendes R. Feasibility and safety of a walking football program in middle-aged and older men with type 2 diabetes. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):786-791. doi: 10.1016/j.pcad.2020.06.014. Epub 2020 Jul 4.