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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: Walking football exercise program

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4050-600
    • Instituto de Saúde Pública da Universidade do Porto

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Exercise; Walking football exercise program

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic control	Glycated hemoglobin (venous blood analysis)	Change from baseline to 3 months
Blood lipid profile	Total cholesterol (venous blood analysis)	Change from baseline to 3 months
Clinical systolic blood pressure	Resting systolic blood pressure	Change from baseline to 3 months
Clinical diastolic blood pressure	Resting diastolic blood pressure	Change from baseline to 3 months
Body mass index	Body mass index	Change from baseline to 3 months
Waist circumference	Waist circumference	Change from baseline to 3 months
Body fat	Body fat (bioelectrical impedance analysis)	Change from baseline to 3 months
Body lean mass	Body lean mass (bioelectrical impedance analysis)	Change from baseline to 3 months
Agility/balance	Timed Up and Go Test	Change from baseline to 3 months
Habitual physical activity	Global Physical Activity Questionnaire	Change from baseline to 3 months
Food pattern	24h-food recall analysis	Change from baseline to 3 months
Cognitive state	Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)	Change from baseline to 3 months
Health-related quality of life	EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)	Change from baseline to 3 months
Medication	Number of medications	Change from baseline to 3 months

Collaborators and Investigators

• Sponsor: Universidade do Porto
• Collaborators: Federation Internationale de Football Association; Administração Regional de Saúde do Norte, Portugal; Federação Portuguesa de Futebol, Portugal
• Investigators: Principal Investigator: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2018
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Physical Activity; Exercise; Feasibility; Primary Health Care; Type 2 Diabetes; Football; Walking Football
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: ISPUP-RMFIFA2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No