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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Walking football exercise program
Sponsored by
Universidade do Porto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Exercise, Physical Activity, Football, Walking Football, Type 2 Diabetes, Primary Health Care, Feasibility, Safety

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Instituto de Saúde Pública da Universidade do Porto

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise

Arm Description

Walking football exercise program

Outcomes

Primary Outcome Measures

Exercise intensity - subjective internal load
OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
Exercise intensity - objective internal load
Heart rate during exercise
Exercise intensity - external load
Distance (km) assessed using GPS tracking during exercise
Acute glycemic effect
Acute change in capillary blood glucose with exercise sessions
Acute systolic blood pressure effect
Acute change in systolic blood pressure with exercise sessions
Acute diastolic blood pressure effect
Acute change in diastolic blood pressure with exercise sessions
Incidence of falls
Number of falls during the exercise program
Incidence of foot injuries
Number of reported foot injuries during the exercise program
Incidence of musculoskeletal injuries
Number of reported musculoskeletal injuries during the exercise program
Rate of Enjoyment
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2019
Last Updated
August 20, 2019
Sponsor
Universidade do Porto
Collaborators
Federação Portuguesa de Futebol, Portugal, Administração Regional de Saúde do Norte, Portugal, Fédération Internationale de Football Association
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1. Study Identification

Unique Protocol Identification Number
NCT03810846
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade do Porto
Collaborators
Federação Portuguesa de Futebol, Portugal, Administração Regional de Saúde do Norte, Portugal, Fédération Internationale de Football Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Exercise, Physical Activity, Football, Walking Football, Type 2 Diabetes, Primary Health Care, Feasibility, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
Walking football exercise program
Intervention Type
Behavioral
Intervention Name(s)
Walking football exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Exercise intensity - subjective internal load
Description
OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
Time Frame
Through 3 months
Title
Exercise intensity - objective internal load
Description
Heart rate during exercise
Time Frame
Through 3 months
Title
Exercise intensity - external load
Description
Distance (km) assessed using GPS tracking during exercise
Time Frame
Through 3 months
Title
Acute glycemic effect
Description
Acute change in capillary blood glucose with exercise sessions
Time Frame
Change between before and immediately after each exercise session
Title
Acute systolic blood pressure effect
Description
Acute change in systolic blood pressure with exercise sessions
Time Frame
Change between before and immediately after each exercise session
Title
Acute diastolic blood pressure effect
Description
Acute change in diastolic blood pressure with exercise sessions
Time Frame
Change between before and immediately after each exercise session
Title
Incidence of falls
Description
Number of falls during the exercise program
Time Frame
Through 3 months
Title
Incidence of foot injuries
Description
Number of reported foot injuries during the exercise program
Time Frame
Through 3 months
Title
Incidence of musculoskeletal injuries
Description
Number of reported musculoskeletal injuries during the exercise program
Time Frame
Through 3 months
Title
Rate of Enjoyment
Description
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
Time Frame
Through 3 months
Secondary Outcome Measure Information:
Title
Glycemic control
Description
Glycated hemoglobin (venous blood analysis)
Time Frame
Change from baseline to 3 months
Title
Blood lipid profile
Description
Total cholesterol (venous blood analysis)
Time Frame
Change from baseline to 3 months
Title
Clinical systolic blood pressure
Description
Resting systolic blood pressure
Time Frame
Change from baseline to 3 months
Title
Clinical diastolic blood pressure
Description
Resting diastolic blood pressure
Time Frame
Change from baseline to 3 months
Title
Body mass index
Description
Body mass index
Time Frame
Change from baseline to 3 months
Title
Waist circumference
Description
Waist circumference
Time Frame
Change from baseline to 3 months
Title
Body fat
Description
Body fat (bioelectrical impedance analysis)
Time Frame
Change from baseline to 3 months
Title
Body lean mass
Description
Body lean mass (bioelectrical impedance analysis)
Time Frame
Change from baseline to 3 months
Title
Agility/balance
Description
Timed Up and Go Test
Time Frame
Change from baseline to 3 months
Title
Habitual physical activity
Description
Global Physical Activity Questionnaire
Time Frame
Change from baseline to 3 months
Title
Food pattern
Description
24h-food recall analysis
Time Frame
Change from baseline to 3 months
Title
Cognitive state
Description
Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
Time Frame
Change from baseline to 3 months
Title
Health-related quality of life
Description
EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
Time Frame
Change from baseline to 3 months
Title
Medication
Description
Number of medications
Time Frame
Change from baseline to 3 months

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Romeu Mendes, MD, PhD
Organizational Affiliation
EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto de Saúde Pública da Universidade do Porto
City
Porto
ZIP/Postal Code
4050-600
Country
Portugal

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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.
Results Reference
background
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.
Results Reference
result
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.
Results Reference
result
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.
Results Reference
result
PubMed Identifier
32634461
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.
Results Reference
derived

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

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