- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04314921
10-week Yoga Practice Effect on Cognitive and Motor Function in Older Adults (BDNF)
10-week Yoga Practice Effect in Older Adults
Thirty-three healthy elderly people, who were classified into two age groups, participated in this study. All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing. In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes. In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
Experimental measurements: Brunel, PSS-14 and HAD questionnaires
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kaunas, Lituania, 44221
- Lithuanian Sports Unviersity
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- age, from 60 years old
- a statement by a local family physician about general good physical health
- never tired to practice yoga before
Exclusion Criteria:
- cardiovascular diseases
- musculoskeletal system diseases (osteoporosis, osteochondrosis, hernias)
- neurodegenerative diseases
- oncological diseases
- glaucoma
- injuries and surgeries in last 3 years
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 10-week Yoga
Eighteen healthy elderly people, who were classified into two age groups, participated in this study.
All participants had not practiced yoga before and were asked not to perform any sports activities while the research was ongoing.
In the experimental group, participants (n = 18) had to participate in 10 weeks of yoga classes.
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
All experimental group subjects participated in Himalayan yoga classes, which lasted 10 weeks: 2 times per week, 90 min per session.
Yoga classes were conducted by 16-year-old qualified yoga instructor from Yoga Academy, Kaunas.
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10-week yoga sessions, 2 times per week, 90 min per session.
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Sin intervención: Control
In the control group, participants (n = 15) did not perform any exercises or other changes in their daily living life.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Brunel mood scale (BRUMS)
Periodo de tiempo: 10 weeks
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The Lithuanian translated version of the Brunel Mood Scale (BRUMS) was used in the present study.
It was based on the originally developed to serve as a brief measure of mood before and after yoga intervention.
The BRUMS (1) scale has 24 items arranged into six subscales: anger, confusion, depression, fatigue, tension and vigor.
Each subscale has a numerical rating scale (0 = not at all, 1 = a bit, 2 = moderate, 3 = enough; 4 = extremely) from which research participant select the one best represents at that time.
The results within subscale is summed and a score range from 0 to 16
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10 weeks
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Hospital anxiety and depression scale (HADS)
Periodo de tiempo: 10 weeks
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To determine the level of anxiety and depression of subjects was used HADS scale.
The scale consists of totally 14 questions with the answers valued from 0 to 3. Half of questions addressed to estimate anxiety and rest - depression.
The total scoring and conclusion for the both categories of questions: 0-7 = Normal; 8-10 = Borderline abnormal (borderline case); 11-21 = Abnormal (case)
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10 weeks
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Perceived stress scale -14
Periodo de tiempo: 10 weeks
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The purpose of this scale is to assess the degree of stress in subjects' lives.
It consists of questions about the frequency of feeling and thoughts during the past time period.
Potential answers: 0-never; 1-almost never; 2-sometimes; 3-fairly often and 4-very often.
The scores are obtained by reversing the scores on the four positive items: for example, 0=4, 1=3, 2=2, etc. and then summing across all items.
Scores for the 14-item form range from 0 to 56, with higher scores indicating greater perceived stress
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10 weeks
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Human Free BDNF
Periodo de tiempo: 10 weeks
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Venous blood samples from median antecubital vein were collected in 5 ml vacuum tubes with a gel separator and was separated by centrifugation (15 min at 1200g) to make blood serum.
Samples were aliquoted and stored at -800C until analysis.
The serum concentration of Human Free BDNF was measured using an enzyme-linked immunoassay kit (R&D Systems, Minneapolis, USA)
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10 weeks
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Measurement of cognitive functions
Periodo de tiempo: 10 weeks
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Automated Neuropsychological Assessment Metrics Version 4 (ANAM-4; Vista Life, USA) was used to measure neurocognitive skills: mental flexibility, verbal working memory, inhibition control, visuospatial processing.
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10 weeks
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Psychomotor function evaluation
Periodo de tiempo: 10 weeks
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Participants were assessed by Dynamic Parameter Analyzer (DPA-1).
Its measure motor functions: accuracy, reaction speed-accuracy.
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10 weeks
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Heart rate variability
Periodo de tiempo: 10 weeks
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R-R intervals were recorded using a Polar H7 sensor with a chest strap (Kempele, Finland).
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10 weeks
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Balance procedure
Periodo de tiempo: 10 weeks
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Postural sway activity was measured by a posturography method with a single piezoelectric force plate (Kistler, Slimline System 9286, Switzerland).
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10 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- LithuanianSportsU-3
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .
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