Yoga Empowers Seniors Study (YESS)
14 de novembro de 2016 atualizado por: George Salem, University of Southern California
Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations
This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program designed for community-dwelling older adults.
Additionally, the IDS will explore the adherence and adverse events of participation in the program.
Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs.
The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy.
The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.
Visão geral do estudo
Descrição detalhada
Yoga is currently being recommended to restore and preserve strength, flexibility, balance, & physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors.
To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, & safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.
Tipo de estudo
Intervencional
Inscrição (Real)
27
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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California
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Los Angeles, California, Estados Unidos, 90024
- UCLA
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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
65 anos e mais velhos (Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Community dwelling men and women volunteers, aged 65 years or older.
Exclusion Criteria:
Safety exclusions:
--the following safety exclusions are adopted in order to decrease potential *cardiovascular
- musculoskeletal
- neurological risks to the participants:
- active angina
- uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)
- high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)
- unstable asthma or exacerbated COPD
- cervical spine instability or other significant neck injury
- rheumatoid arthritis
- unstable ankle, knee, hip, shoulder, elbow, or wrist joints
- hemiparesis or paraparesis
- movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems
- walker or wheelchair use
- insufficient hearing to permit safety in a yoga group setting
- not able to attend in-person classes
- has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)
Feasibility/adherence exclusions:
- unable to understand their commitment to the project, (laboratory visits & regular program participation)
- cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety
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: Ciência básica
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: yoga
32 weeks of yoga training
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yoga classes 2 times per week for 32 weeks
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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peak joint moments
Prazo: difference from baseline to 16 wk
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These are the torques produced by the muscles during performance of the yoga poses
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difference from baseline to 16 wk
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peak joint moments
Prazo: difference from 16 wk to 32 wk
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These are the torques produced by the muscles during performance of the yoga poses
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difference from 16 wk to 32 wk
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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time to stand and sit from a chair 5 times
Prazo: baseline, 16 and 32 weeks
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In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.
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baseline, 16 and 32 weeks
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number of heel-rise repetitions
Prazo: baseline, 16 and 32 weeks
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The Heel-Rise Test is a measure of plantar-flexion endurance.
Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.
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baseline, 16 and 32 weeks
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Time to complete Up & Go test
Prazo: baseline, 16 and 32 weeks
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In the Up & Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.
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baseline, 16 and 32 weeks
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Number of marching steps completed within 2 minutes
Prazo: baseline, 16 and 32 weeks
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In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period
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baseline, 16 and 32 weeks
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Distance participant can reach forward from a sitting position
Prazo: baseline, 16 and 32 weeks
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The sit and reach test measures overall sagittal-plane flexibility.
The participant is asked to reach as far as possible toward their dominant limb while remaining seated.
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baseline, 16 and 32 weeks
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Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
Prazo: baseline, 16 and 32 weeks
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The Back Scratch Test measures upper extremity flexibility.
Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.
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baseline, 16 and 32 weeks
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Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
Prazo: baseline, 16 and 32 weeks
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These tests measure the range of motion of the wrist in the sagittal and frontal planes.
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baseline, 16 and 32 weeks
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Maximum height participant can reach while standing
Prazo: baseline, 16 and 32 weeks
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Here we quantify the maximum vertical height participants can reach while standing.
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baseline, 16 and 32 weeks
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Maximum distance participant can reach forward while standing
Prazo: baseline, 16 and 32 weeks
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THe Maximum Forward Reach test is a measure of strength and flexibility.
Here we record the maximum distance the participant can reach forward while standing.
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baseline, 16 and 32 weeks
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stride length during walking
Prazo: baseline, 16 and 32 weeks
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Here we quantify the stride length of participants during walking at a self-selected pace.
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baseline, 16 and 32 weeks
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Maximum joint angle
Prazo: baseline, 16 and 32 weeks
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Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.
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baseline, 16 and 32 weeks
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Sway distance of the center of pressure
Prazo: baseline, 16 and 32 weeks
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Here we quantify the movement of the center of pressure as participants stand as still as possible
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baseline, 16 and 32 weeks
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Electromyographic activity of muscles
Prazo: baseline, 16 and 32 weeks
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Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.
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baseline, 16 and 32 weeks
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SF-36 score
Prazo: baseline and 36 weeks
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Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993).
The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.
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baseline and 36 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: George Salem, PhD, University of Southern California
Publicações e links úteis
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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
1 de julho de 2009
Conclusão Primária (Real)
1 de abril de 2011
Conclusão do estudo (Real)
1 de abril de 2011
Datas de inscrição no estudo
Enviado pela primeira vez
20 de julho de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de agosto de 2011
Primeira postagem (Estimativa)
5 de agosto de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
16 de novembro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de novembro de 2016
Última verificação
1 de novembro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 1R01AT004869-01 (Concessão/Contrato do NIH dos EUA)
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