Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20 agosto 2019 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Porto, Portogallo, 4050-600
- Instituto de Saude Publica da Universidade do Porto
-
-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 50 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Maschio
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Exercise intensity - subjective internal load
Lasso di tempo: 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
Lasso di tempo: Through 3 months
|
Heart rate during exercise
|
Through 3 months
|
|
Exercise intensity - external load
Lasso di tempo: Through 3 months
|
Distance (km) assessed using GPS tracking during exercise
|
Through 3 months
|
|
Acute glycemic effect
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Through 3 months
|
Number of falls during the exercise program
|
Through 3 months
|
|
Incidence of foot injuries
Lasso di tempo: Through 3 months
|
Number of reported foot injuries during the exercise program
|
Through 3 months
|
|
Incidence of musculoskeletal injuries
Lasso di tempo: Through 3 months
|
Number of reported musculoskeletal injuries during the exercise program
|
Through 3 months
|
|
Rate of Enjoyment
Lasso di tempo: Through 3 months
|
Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
|
Through 3 months
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Glycemic control
Lasso di tempo: Change from baseline to 3 months
|
Glycated hemoglobin (venous blood analysis)
|
Change from baseline to 3 months
|
|
Blood lipid profile
Lasso di tempo: Change from baseline to 3 months
|
Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
|
Clinical systolic blood pressure
Lasso di tempo: Change from baseline to 3 months
|
Resting systolic blood pressure
|
Change from baseline to 3 months
|
|
Clinical diastolic blood pressure
Lasso di tempo: Change from baseline to 3 months
|
Resting diastolic blood pressure
|
Change from baseline to 3 months
|
|
Body mass index
Lasso di tempo: Change from baseline to 3 months
|
Body mass index
|
Change from baseline to 3 months
|
|
Waist circumference
Lasso di tempo: Change from baseline to 3 months
|
Waist circumference
|
Change from baseline to 3 months
|
|
Body fat
Lasso di tempo: Change from baseline to 3 months
|
Body fat (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Body lean mass
Lasso di tempo: Change from baseline to 3 months
|
Body lean mass (bioelectrical impedance analysis)
|
Change from baseline to 3 months
|
|
Agility/balance
Lasso di tempo: Change from baseline to 3 months
|
Timed Up and Go Test
|
Change from baseline to 3 months
|
|
Habitual physical activity
Lasso di tempo: Change from baseline to 3 months
|
Global Physical Activity Questionnaire
|
Change from baseline to 3 months
|
|
Food pattern
Lasso di tempo: Change from baseline to 3 months
|
24h-food recall analysis
|
Change from baseline to 3 months
|
|
Cognitive state
Lasso di tempo: 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
Lasso di tempo: Change from baseline to 3 months
|
EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
|
Change from baseline to 3 months
|
|
Medication
Lasso di tempo: Change from baseline to 3 months
|
Number of medications
|
Change from baseline to 3 months
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- 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.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
17 settembre 2018
Completamento primario (Effettivo)
31 gennaio 2019
Completamento dello studio (Effettivo)
30 giugno 2019
Date di iscrizione allo studio
Primo inviato
10 gennaio 2019
Primo inviato che soddisfa i criteri di controllo qualità
16 gennaio 2019
Primo Inserito (Effettivo)
22 gennaio 2019
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
22 agosto 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
20 agosto 2019
Ultimo verificato
1 agosto 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- ISPUP-RMFIFA2018
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Walking football exercise program
-
Newcastle UniversityNorthumbria Healthcare NHS Foundation TrustCompletatoArtrosi al ginocchioRegno Unito