Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Sep 2018
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2018
CompletedFirst Submitted
Initial submission to the registry
January 10, 2019
CompletedFirst Posted
Study publicly available on registry
January 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedAugust 22, 2019
August 1, 2019
5 months
January 10, 2019
August 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Exercise intensity - subjective internal load
OMNI rating of perceived exertion scale during exercise (0 \[lowest\] to 10 \[highest\] points)
Through 3 months
Exercise intensity - objective internal load
Heart rate during exercise
Through 3 months
Exercise intensity - external load
Distance (km) assessed using GPS tracking during exercise
Through 3 months
Acute glycemic effect
Acute change in capillary blood glucose with exercise sessions
Change between before and immediately after each exercise session
Acute systolic blood pressure effect
Acute change in systolic blood pressure with exercise sessions
Change between before and immediately after each exercise session
Acute diastolic blood pressure effect
Acute change in diastolic blood pressure with exercise sessions
Change between before and immediately after each exercise session
Incidence of falls
Number of falls during the exercise program
Through 3 months
Incidence of foot injuries
Number of reported foot injuries during the exercise program
Through 3 months
Incidence of musculoskeletal injuries
Number of reported musculoskeletal injuries during the exercise program
Through 3 months
Rate of Enjoyment
Self-reported exercise sessions' enjoyment on a likert scale (1 \[lowest\] to 5 \[highest\] points)
Through 3 months
Secondary Outcomes (14)
Glycemic control
Change from baseline to 3 months
Blood lipid profile
Change from baseline to 3 months
Clinical systolic blood pressure
Change from baseline to 3 months
Clinical diastolic blood pressure
Change from baseline to 3 months
Body mass index
Change from baseline to 3 months
- +9 more secondary outcomes
Study Arms (1)
Exercise
EXPERIMENTALWalking football exercise program
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- cardiological stress test with cardiac or hemodynamic problems
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Saúde Pública da Universidade do Porto
Porto, 4050-600, Portugal
Related Publications (5)
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.
BACKGROUNDBarbosa 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.
RESULTRago 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.
RESULTCosta 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.
RESULTBarbosa 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.
PMID: 32634461DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Romeu Mendes, MD, PhD
EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
January 10, 2019
First Posted
January 22, 2019
Study Start
September 17, 2018
Primary Completion
January 31, 2019
Study Completion
June 30, 2019
Last Updated
August 22, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share