Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20 de agosto de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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-
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Porto, Portugal, 4050-600
- Instituto de Saúde Pública da Universidade do Porto
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
50 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Masculino
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Exercise intensity - subjective internal load
Periodo de tiempo: 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
Periodo de tiempo: Through 3 months
|
Heart rate during exercise
|
Through 3 months
|
|
Exercise intensity - external load
Periodo de tiempo: Through 3 months
|
Distance (km) assessed using GPS tracking during exercise
|
Through 3 months
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Acute glycemic effect
Periodo de tiempo: Change between before and immediately after each exercise session
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Acute change in capillary blood glucose with exercise sessions
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Change between before and immediately after each exercise session
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Acute systolic blood pressure effect
Periodo de tiempo: Change between before and immediately after each exercise session
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Acute change in systolic blood pressure with exercise sessions
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Change between before and immediately after each exercise session
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Acute diastolic blood pressure effect
Periodo de tiempo: Change between before and immediately after each exercise session
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Acute change in diastolic blood pressure with exercise sessions
|
Change between before and immediately after each exercise session
|
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Incidence of falls
Periodo de tiempo: Through 3 months
|
Number of falls during the exercise program
|
Through 3 months
|
|
Incidence of foot injuries
Periodo de tiempo: Through 3 months
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Number of reported foot injuries during the exercise program
|
Through 3 months
|
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Incidence of musculoskeletal injuries
Periodo de tiempo: Through 3 months
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Number of reported musculoskeletal injuries during the exercise program
|
Through 3 months
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Rate of Enjoyment
Periodo de tiempo: Through 3 months
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Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
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Through 3 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Glycemic control
Periodo de tiempo: Change from baseline to 3 months
|
Glycated hemoglobin (venous blood analysis)
|
Change from baseline to 3 months
|
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Blood lipid profile
Periodo de tiempo: Change from baseline to 3 months
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Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
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Clinical systolic blood pressure
Periodo de tiempo: Change from baseline to 3 months
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Resting systolic blood pressure
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Change from baseline to 3 months
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Clinical diastolic blood pressure
Periodo de tiempo: Change from baseline to 3 months
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Resting diastolic blood pressure
|
Change from baseline to 3 months
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Body mass index
Periodo de tiempo: Change from baseline to 3 months
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Body mass index
|
Change from baseline to 3 months
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Waist circumference
Periodo de tiempo: Change from baseline to 3 months
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Waist circumference
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Change from baseline to 3 months
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Body fat
Periodo de tiempo: Change from baseline to 3 months
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Body fat (bioelectrical impedance analysis)
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Change from baseline to 3 months
|
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Body lean mass
Periodo de tiempo: Change from baseline to 3 months
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Body lean mass (bioelectrical impedance analysis)
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Change from baseline to 3 months
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Agility/balance
Periodo de tiempo: Change from baseline to 3 months
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Timed Up and Go Test
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Change from baseline to 3 months
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Habitual physical activity
Periodo de tiempo: Change from baseline to 3 months
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Global Physical Activity Questionnaire
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Change from baseline to 3 months
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Food pattern
Periodo de tiempo: Change from baseline to 3 months
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24h-food recall analysis
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Change from baseline to 3 months
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Cognitive state
Periodo de tiempo: Change from baseline to 3 months
|
Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
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Change from baseline to 3 months
|
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Health-related quality of life
Periodo de tiempo: Change from baseline to 3 months
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EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
|
Change from baseline to 3 months
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Medication
Periodo de tiempo: Change from baseline to 3 months
|
Number of medications
|
Change from baseline to 3 months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
17 de septiembre de 2018
Finalización primaria (Actual)
31 de enero de 2019
Finalización del estudio (Actual)
30 de junio de 2019
Fechas de registro del estudio
Enviado por primera vez
10 de enero de 2019
Primero enviado que cumplió con los criterios de control de calidad
16 de enero de 2019
Publicado por primera vez (Actual)
22 de enero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de agosto de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
20 de agosto de 2019
Última verificación
1 de agosto de 2019
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ISPUP-RMFIFA2018
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .