Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20. srpna 2019 aktualizováno: Romeu Mendes, Universidade do Porto
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.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
-
-
Porto, Portugalsko, 4050-600
- Instituto de Saúde Pública da Universidade do Porto
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
50 let až 70 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Mužský
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Exercise
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exercise intensity - subjective internal load
Časové okno: Through 3 months
|
OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
|
Through 3 months
|
|
Exercise intensity - objective internal load
Časové okno: Through 3 months
|
Heart rate during exercise
|
Through 3 months
|
|
Exercise intensity - external load
Časové okno: Through 3 months
|
Distance (km) assessed using GPS tracking during exercise
|
Through 3 months
|
|
Acute glycemic effect
Časové okno: Change between before and immediately after each exercise session
|
Acute change in capillary blood glucose with exercise sessions
|
Change between before and immediately after each exercise session
|
|
Acute systolic blood pressure effect
Časové okno: Change between before and immediately after each exercise session
|
Acute change in systolic blood pressure with exercise sessions
|
Change between before and immediately after each exercise session
|
|
Acute diastolic blood pressure effect
Časové okno: Change between before and immediately after each exercise session
|
Acute change in diastolic blood pressure with exercise sessions
|
Change between before and immediately after each exercise session
|
|
Incidence of falls
Časové okno: Through 3 months
|
Number of falls during the exercise program
|
Through 3 months
|
|
Incidence of foot injuries
Časové okno: Through 3 months
|
Number of reported foot injuries during the exercise program
|
Through 3 months
|
|
Incidence of musculoskeletal injuries
Časové okno: Through 3 months
|
Number of reported musculoskeletal injuries during the exercise program
|
Through 3 months
|
|
Rate of Enjoyment
Časové okno: Through 3 months
|
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
|
Through 3 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Glycemic control
Časové okno: Change from baseline to 3 months
|
Glycated hemoglobin (venous blood analysis)
|
Change from baseline to 3 months
|
|
Blood lipid profile
Časové okno: Change from baseline to 3 months
|
Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
|
Clinical systolic blood pressure
Časové okno: Change from baseline to 3 months
|
Resting systolic blood pressure
|
Change from baseline to 3 months
|
|
Clinical diastolic blood pressure
Časové okno: Change from baseline to 3 months
|
Resting diastolic blood pressure
|
Change from baseline to 3 months
|
|
Body mass index
Časové okno: Change from baseline to 3 months
|
Body mass index
|
Change from baseline to 3 months
|
|
Waist circumference
Časové okno: Change from baseline to 3 months
|
Waist circumference
|
Change from baseline to 3 months
|
|
Body fat
Časové okno: Change from baseline to 3 months
|
Body fat (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Body lean mass
Časové okno: Change from baseline to 3 months
|
Body lean mass (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Agility/balance
Časové okno: Change from baseline to 3 months
|
Timed Up and Go Test
|
Change from baseline to 3 months
|
|
Habitual physical activity
Časové okno: Change from baseline to 3 months
|
Global Physical Activity Questionnaire
|
Change from baseline to 3 months
|
|
Food pattern
Časové okno: Change from baseline to 3 months
|
24h-food recall analysis
|
Change from baseline to 3 months
|
|
Cognitive state
Časové okno: Change from baseline to 3 months
|
Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
|
Change from baseline to 3 months
|
|
Health-related quality of life
Časové okno: Change from baseline to 3 months
|
EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
|
Change from baseline to 3 months
|
|
Medication
Časové okno: Change from baseline to 3 months
|
Number of medications
|
Change from baseline to 3 months
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
17. září 2018
Primární dokončení (Aktuální)
31. ledna 2019
Dokončení studie (Aktuální)
30. června 2019
Termíny zápisu do studia
První předloženo
10. ledna 2019
První předloženo, které splnilo kritéria kontroly kvality
16. ledna 2019
První zveřejněno (Aktuální)
22. ledna 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
22. srpna 2019
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
20. srpna 2019
Naposledy ověřeno
1. srpna 2019
Více informací
Termíny související s touto studií
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