Practicing Restorative Yoga or Stretching for the Metabolic Syndrome (PRYSMS)
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Metabolic abnormalities, including visceral adiposity, insulin resistance, hyperglycemia, hypertension and dyslipidemia, occur together and are associated with excessive caloric intake and inadequate physical activity. Persons with the metabolic syndrome are at high risk of developing type 2 diabetes and cardiovascular disease. Lifestyle and behavioral interventions reduce these risks, but many individuals with increased metabolic risk find it difficult to achieve and maintain weight loss and increased physical activity.
We are conducting a rigorous randomized controlled trial at two clinical sites to determine if Restorative yoga compared to stretching exercises improves the metabolic syndrome among overweight and underactive individuals who meet criteria for the metabolic syndrome.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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California
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San Diego, California, Estados Unidos, 92037
- University of California, San Diego
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San Francisco, California, Estados Unidos, 94115
- Unversity of California, San Francisco
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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:
- Anyone between the ages of 21 and 65 who may meet the criteria for the metabolic syndrome can sign-up for the screening process. A more thorough screening process will be conducted to determine whether or not you are eligible to enroll in the study
- Underactive
- Overweight
Exclusion Criteria:
- Pregnancy or breast feeding
- Chronic illnesses: cancer, kidney disease, cirrhosis of the liver, rheumatologic diseases, or chronic infections
- Not ambulatory or neurological condition causing impaired mobility
- Weight over 400 pounds
- History of or plans for bariatric surgery
- Inability to speak and read English
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Restorative yoga intervention
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Group yoga sessions: Participants will attend 90 minute yoga group classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. We plan a progressive series of classes, with a subset of poses for each class and then selecting individual poses to focus on in each class. Home yoga practice: Participants will be given a video disk (DVD) of the yoga postures at the start of the yoga intervention practice. We will also provide the yoga participants with a written manual with pictures and descriptions of each posture that they will be taught in the group sessions. The participants will be asked to practice the postures taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given a set of yoga props for their use at home. We will ask all participants to keep a log of their home practice sessions |
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Comparador Ativo: Grupo de alongamento
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Group classes: Participants will attend 90 minute group stretching classes for 48 weeks: twice a week for 6 weeks, then once weekly during weeks 7 to 12, then every other week for weeks 13 - 24, and once a month for 6 months. The stretches will address all body parts, including cervical, upper extremity, thoracic, lumbar, pelvic, and lower extremity musculature. Home stretching practice: Each participant will receive a written manual with pictures and descriptions of each stretch that they will be learning in group sessions and a DVD with instruction on each of the stretches. The participants will be asked to practice the stretches taught during their group sessions at home at least three times a week with the assistance of the DVD and manual. Each participant will be given stretching supplies. We will ask all participants to keep a log of their home practice sessions. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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visceral adiposity by abdominal CT scan
Prazo: 6-months and 12-months
|
6-months and 12-months
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
systolic blood pressure, fasting triglycerides, and fasting insulin levels (co-primary outcomes); change in glucose tolerance, HbA1c levels, high density lipoprotein (HDL) cholesterol, and quality of life (secondary outcomes).
Prazo: 6-months and 12-months
|
6-months and 12-months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alka Kanaya, MD, University of California, San Francisco
Publicações e links úteis
Publicações Gerais
- Flowers E, Allen IE, Kanaya AM, Aouizerat BE. Circulating MicroRNAs predict glycemic improvement and response to a behavioral intervention. Biomark Res. 2021 Aug 23;9(1):65. doi: 10.1186/s40364-021-00317-5.
- Corey SM, Epel E, Schembri M, Pawlowsky SB, Cole RJ, Araneta MR, Barrett-Connor E, Kanaya AM. Effect of restorative yoga vs. stretching on diurnal cortisol dynamics and psychosocial outcomes in individuals with the metabolic syndrome: the PRYSMS randomized controlled trial. Psychoneuroendocrinology. 2014 Nov;49:260-71. doi: 10.1016/j.psyneuen.2014.07.012. Epub 2014 Jul 21.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
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 (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1R01AT004569-01A2 (Concessão/Contrato do NIH dos EUA)
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