- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05184673
Moderate Aerobic Activity Through Yoga (MAT)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The 2018 Physical Activity Guidelines for Americans recommend 150 minutes of moderate intensity physical activity each week to promote health. The most recent scientific advisory committee had insufficient evidence to provide recommendations on how the physical practice of yoga fits into the physical activity guidelines. Currently, there have been few studies done on yoga and its relative intensity. Previous randomized, cross-over trial to determine the effects of room temperature (hot yoga versus thermo-neutral environment) on subjective and objective markers of exercise intensity. They concluded that using objective markers (%VO2max) both thermo-neutral and hot yoga would be considered light intensity activity. Previous investigation of power yoga, heart rate, skin temperature, and body mass to determine that power yoga could be considered a moderate-vigorous intensity activity.
Currently, there is a gap in the research on understanding the intensity of exercise offered within a typical yoga studio including "flow", hatha/classical, and hot yoga. Most yoga classes are about 60 minutes in length, and yoga classes of that length have not been investigated. There is also minimal research done on whether wearable activity trackers and accelerometers are able to accurately assess heart rate, and therefore activity intensity level in a yoga setting.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
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Virginia
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Blacksburg, Virginia, Estados Unidos, 24060
- Samantha M Harden
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Assessed as physical activity readiness i. For those 65-70 years of age. We will also use the Physical Readiness Questionnaire Plus-this "plus" version was developed to be more inclusive of those with limited mobility and not to over-exclude older adults in other clinical trials. If a participant fails the Physical Activity Readiness Questionnaire + (PARQ+), a physician's approval will be mandatory ii. For those 70-85 years of age. Complete PARQ+ as well as physician approval.
- Comprehension of English language
- Able to physically attend class at the yoga studio
Exclusion Criteria:
- Contraindication to physical activity including but not limited to people who can independently walk and stand. This will be part of the verbal screening protocol using Falls Efficacy Scale (FES). This scale has a minimum of 16 (no concern about falling) to maximum of 64 (severe concern about falling). Participants with FES score > 23 will be deemed high concern about falling and be excluded from participation.
- Assesses the presence and severity of 13 psychiatric symptom domains that cut across diagnostic boundaries. These domains include depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts and behaviors, suicidal thoughts and behaviors, substance use (e.g., alcohol, nicotine, prescription medication, and illicit substance use), personality functioning, dissociation, and cognition/memory problems in adults. Level 1 of this measure includes 23 questions across the 13 domains.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: hatha thermo-neutral
The hatha classes will hold each pose for 5 breaths in a room temperature (~70 degrees Fahrenheit) space.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Comparador Ativo: hatha hot
The hatha hot classes will hold each pose for 5 breaths in a room heated to 95 degrees Fahrenheit.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Comparador Ativo: flow thermo-neutral
The flow hot classes will flow from each pose (one breath per movement) a room temperature (~70 degrees Fahrenheit) space.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
|
Comparador Ativo: flow hot
The flow hot classes will flow from each pose (one breath per movement) in a room heated to 95 degrees Fahrenheit.
Yoga sessions will be led by a 500hr Registered Yoga Teacher.
This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice.
All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
|
These are all active comparator yoga sequences
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Continuous heart rate
Prazo: orientation to week 0 (baseline)
|
Polar Version OH1
|
orientation to week 0 (baseline)
|
|
Continuous heart rate
Prazo: orientation to week 1
|
Polar Version OH1
|
orientation to week 1
|
|
Continuous heart rate
Prazo: orientation to week 1.5
|
Polar Version OH1
|
orientation to week 1.5
|
|
Continuous heart rate
Prazo: orientation to week 2
|
Polar Version OH1
|
orientation to week 2
|
|
Continuous heart rate
Prazo: orientation to week 2.5
|
Polar Version OH1
|
orientation to week 2.5
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Modified Borg Scale
Prazo: orientation to week 1
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1
|
|
Modified Borg Scale
Prazo: orientation to week 1.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1.5
|
|
Modified Borg Scale
Prazo: orientation to week 2
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2
|
|
Modified Borg Scale
Prazo: orientation to week 2.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2.5
|
|
Yoga Self Efficacy Scale
Prazo: Baseline
|
12-item, 9 point Likert scale, higher score, more self-efficacious
|
Baseline
|
|
Stanford Leisure-Time Activity Categorical Item
Prazo: Baseline
|
Score of 1-6, higher is better outcome
|
Baseline
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samantha M Harden, PhD, Virginia Polytechnic Institute and State University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 21-325
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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