Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20. august 2019 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Porto, Portugal, 4050-600
- Instituto de Saúde Pública da Universidade do Porto
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
50 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
|
Medication
Tidsramme: Change from baseline to 3 months
|
Number of medications
|
Change from baseline to 3 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. september 2018
Primær færdiggørelse (Faktiske)
31. januar 2019
Studieafslutning (Faktiske)
30. juni 2019
Datoer for studieregistrering
Først indsendt
10. januar 2019
Først indsendt, der opfyldte QC-kriterier
16. januar 2019
Først opslået (Faktiske)
22. januar 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. august 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2019
Sidst verificeret
1. august 2019
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ISPUP-RMFIFA2018
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