Yoga Empowers Seniors Study (YESS)
14 de noviembre de 2016 actualizado 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.
Descripción general del estudio
Estado
Estado
Terminado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
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 estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
Inscripción
27
Fase
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
-
-
California
-
Los Angeles, California, Estados Unidos, 90024
- UCLA
-
-
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
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
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: Ciencia básica
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
1
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
|
Experimental: yoga
32 weeks of yoga training
|
yoga classes 2 times per week for 32 weeks
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
peak joint moments
Periodo de tiempo: difference from baseline to 16 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from baseline to 16 wk
|
|
peak joint moments
Periodo de tiempo: difference from 16 wk to 32 wk
|
These are the torques produced by the muscles during performance of the yoga poses
|
difference from 16 wk to 32 wk
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
time to stand and sit from a chair 5 times
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
number of heel-rise repetitions
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
Time to complete Up & Go test
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
Number of marching steps completed within 2 minutes
Periodo de tiempo: baseline, 16 and 32 weeks
|
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
|
baseline, 16 and 32 weeks
|
|
Distance participant can reach forward from a sitting position
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).
Periodo de tiempo: baseline, 16 and 32 weeks
|
These tests measure the range of motion of the wrist in the sagittal and frontal planes.
|
baseline, 16 and 32 weeks
|
|
Maximum height participant can reach while standing
Periodo de tiempo: baseline, 16 and 32 weeks
|
Here we quantify the maximum vertical height participants can reach while standing.
|
baseline, 16 and 32 weeks
|
|
Maximum distance participant can reach forward while standing
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
stride length during walking
Periodo de tiempo: baseline, 16 and 32 weeks
|
Here we quantify the stride length of participants during walking at a self-selected pace.
|
baseline, 16 and 32 weeks
|
|
Maximum joint angle
Periodo de tiempo: baseline, 16 and 32 weeks
|
Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.
|
baseline, 16 and 32 weeks
|
|
Sway distance of the center of pressure
Periodo de tiempo: baseline, 16 and 32 weeks
|
Here we quantify the movement of the center of pressure as participants stand as still as possible
|
baseline, 16 and 32 weeks
|
|
Electromyographic activity of muscles
Periodo de tiempo: baseline, 16 and 32 weeks
|
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.
|
baseline, 16 and 32 weeks
|
|
SF-36 score
Periodo de tiempo: baseline and 36 weeks
|
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.
|
baseline and 36 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Colaboradores
Colaboradores
Investigadores
Investigadores
- Investigador principal: George Salem, PhD, University of Southern California
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.
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
Inicio del estudio
1 de julio de 2009
Finalización primaria (Actual)
Finalización primaria
1 de abril de 2011
Finalización del estudio (Actual)
Finalización del estudio
1 de abril de 2011
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
20 de julio de 2011
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
4 de agosto de 2011
Publicado por primera vez (Estimar)
Publicado por primera vez
5 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización publicada
16 de noviembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
14 de noviembre de 2016
Última verificación
Última verificación
1 de noviembre de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
Otros números de identificación del estudio
- 1R01AT004869-01 (Subvención/contrato del NIH de EE. UU.)
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. .