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

NCT ID: NCT03810846

Last Updated: 2019-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-06-30

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Exercise

Walking football exercise program

Group Type EXPERIMENTAL

Walking football exercise program

Intervention Type 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.

Interventions

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Walking 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Federação Portuguesa de Futebol, Portugal

UNKNOWN

Sponsor Role collaborator

Administração Regional de Saúde do Norte, Portugal

OTHER

Sponsor Role collaborator

Fédération Internationale de Football Association

UNKNOWN

Sponsor Role collaborator

Universidade do Porto

OTHER

Sponsor Role lead

Responsible Party

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Romeu Mendes

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Romeu Mendes, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

EPIUnit - Instituto de Saúde Pública, Universidade do Porto

Locations

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Instituto de Saúde Pública da Universidade do Porto

Porto, , Portugal

Site Status

Countries

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Portugal

References

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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.

Reference Type BACKGROUND

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type RESULT

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.

Reference Type DERIVED
PMID: 32634461 (View on PubMed)

Other Identifiers

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ISPUP-RMFIFA2018

Identifier Type: -

Identifier Source: org_study_id

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