Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20. august 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
-
Porto, Portugal, 4050-600
- Instituto de Saúde Pública da Universidade do Porto
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
50 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Exercise intensity - subjective internal load
Tidsramme: 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
Tidsramme: Through 3 months
|
Heart rate during exercise
|
Through 3 months
|
|
Exercise intensity - external load
Tidsramme: Through 3 months
|
Distance (km) assessed using GPS tracking during exercise
|
Through 3 months
|
|
Acute glycemic effect
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Through 3 months
|
Number of falls during the exercise program
|
Through 3 months
|
|
Incidence of foot injuries
Tidsramme: Through 3 months
|
Number of reported foot injuries during the exercise program
|
Through 3 months
|
|
Incidence of musculoskeletal injuries
Tidsramme: Through 3 months
|
Number of reported musculoskeletal injuries during the exercise program
|
Through 3 months
|
|
Rate of Enjoyment
Tidsramme: Through 3 months
|
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
|
Through 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Glycemic control
Tidsramme: Change from baseline to 3 months
|
Glycated hemoglobin (venous blood analysis)
|
Change from baseline to 3 months
|
|
Blood lipid profile
Tidsramme: Change from baseline to 3 months
|
Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
|
Clinical systolic blood pressure
Tidsramme: Change from baseline to 3 months
|
Resting systolic blood pressure
|
Change from baseline to 3 months
|
|
Clinical diastolic blood pressure
Tidsramme: Change from baseline to 3 months
|
Resting diastolic blood pressure
|
Change from baseline to 3 months
|
|
Body mass index
Tidsramme: Change from baseline to 3 months
|
Body mass index
|
Change from baseline to 3 months
|
|
Waist circumference
Tidsramme: Change from baseline to 3 months
|
Waist circumference
|
Change from baseline to 3 months
|
|
Body fat
Tidsramme: Change from baseline to 3 months
|
Body fat (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Body lean mass
Tidsramme: Change from baseline to 3 months
|
Body lean mass (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Agility/balance
Tidsramme: Change from baseline to 3 months
|
Timed Up and Go Test
|
Change from baseline to 3 months
|
|
Habitual physical activity
Tidsramme: Change from baseline to 3 months
|
Global Physical Activity Questionnaire
|
Change from baseline to 3 months
|
|
Food pattern
Tidsramme: Change from baseline to 3 months
|
24h-food recall analysis
|
Change from baseline to 3 months
|
|
Cognitive state
Tidsramme: 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
Tidsramme: Change from baseline to 3 months
|
EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
|
Change from baseline to 3 months
|
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Medication
Tidsramme: Change from baseline to 3 months
|
Number of medications
|
Change from baseline to 3 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. september 2018
Primær fullføring (Faktiske)
31. januar 2019
Studiet fullført (Faktiske)
30. juni 2019
Datoer for studieregistrering
Først innsendt
10. januar 2019
Først innsendt som oppfylte QC-kriteriene
16. januar 2019
Først lagt ut (Faktiske)
22. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. august 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2019
Sist bekreftet
1. august 2019
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ISPUP-RMFIFA2018
Plan for individuelle deltakerdata (IPD)
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Nei
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