Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
20 de agosto de 2019 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
40
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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-
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Porto, Portugal, 4050-600
- Instituto de Saúde Pública da Universidade do Porto
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
50 anos a 70 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Macho
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Exercise intensity - subjective internal load
Prazo: Through 3 months
|
OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
|
Through 3 months
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Exercise intensity - objective internal load
Prazo: Through 3 months
|
Heart rate during exercise
|
Through 3 months
|
|
Exercise intensity - external load
Prazo: Through 3 months
|
Distance (km) assessed using GPS tracking during exercise
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Through 3 months
|
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Acute glycemic effect
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Through 3 months
|
Number of falls during the exercise program
|
Through 3 months
|
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Incidence of foot injuries
Prazo: Through 3 months
|
Number of reported foot injuries during the exercise program
|
Through 3 months
|
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Incidence of musculoskeletal injuries
Prazo: Through 3 months
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Number of reported musculoskeletal injuries during the exercise program
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Through 3 months
|
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Rate of Enjoyment
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Glycemic control
Prazo: Change from baseline to 3 months
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Glycated hemoglobin (venous blood analysis)
|
Change from baseline to 3 months
|
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Blood lipid profile
Prazo: Change from baseline to 3 months
|
Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
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Clinical systolic blood pressure
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Change from baseline to 3 months
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Waist circumference
|
Change from baseline to 3 months
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Body fat
Prazo: 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
Prazo: Change from baseline to 3 months
|
Body lean mass (bioelectrical impedance analysis)
|
Change from baseline to 3 months
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Agility/balance
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Change from baseline to 3 months
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Number of medications
|
Change from baseline to 3 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Romeu Mendes, MD, PhD, EPIUnit - Instituto de Saúde Pública, Universidade do Porto
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
17 de setembro de 2018
Conclusão Primária (Real)
31 de janeiro de 2019
Conclusão do estudo (Real)
30 de junho de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
10 de janeiro de 2019
Enviado pela primeira vez que atendeu aos critérios de CQ
16 de janeiro de 2019
Primeira postagem (Real)
22 de janeiro de 2019
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de agosto de 2019
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de agosto de 2019
Última verificação
1 de agosto de 2019
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ISPUP-RMFIFA2018
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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