LoveYourBrain Yoga for Multiple Sclerosis
4 de febrero de 2020 actualizado por: Andrew D. Smith III, Dartmouth-Hitchcock Medical Center
The Acceptability, Feasibility, and Impact of a Group-based Yoga and Psychoeducation Program for Community-dwelling Adults With Multiple Sclerosis: A Randomized, Cross-over Pilot Study
The purpose of the study is to assess the feasibility of a 6-week yoga and meditation intervention for people with multiple sclerosis (MS).
The study will evaluate the impact of the program on fatigue, anxiety, depression, positive affect, and other measures.
A sub-study will collect brain images using MRI on 2 subjects before and after the intervention to identify potential biological markers of MS related-fatigue.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study will recruit 20 subjects with multiple sclerosis (MS) to participate in a 6-week yoga/meditation program.
Subjects will be randomly assigned to one of two groups.
The first group will complete the yoga/meditation classes, followed by a waiting period.
The second group will go through a waiting period, followed by yoga/meditation classes.
Two subjects assigned to classes during the first session will be selected to participate in an MRI sub-study to look for biomarkers of MS-associated fatigue.
All subjects will complete questionnaires and assessments during 3 clinic visits - at baseline, in between the class sessions, and at the end of the study.
Questionnaires will also be mailed to subjects 6 weeks after the last study visit.
Tipo de estudio
Intervencionista
Inscripción (Actual)
15
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
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New Hampshire
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Lebanon, New Hampshire, Estados Unidos, 03756
- Dartmouth-Hitchcock Medical Center
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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
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of Multiple Sclerosis with EDSS score equal to or less than 6 (within last year)
- 18 years of age or older
- Ability to ambulate without assistance from a device or person
- Subjects taking medications for depression, fatigue, or anxiety must be stable for 8 weeks prior to baseline
- Able to read, write, and speak English
- Willing to refrain from participating in yoga or meditation outside of the study for the duration of enrollment
- Willing and able to give informed consent
Exclusion Criteria:
- Participation in yoga and/or meditation more than twice within 8 weeks prior to baseline.
- MS symptom exacerbation in the 8 weeks before baseline or other serious medical conditions that would impair ability to participate in the study.
- Any other reason that, in the investigator's opinion, would exclude the subject from participation in the study.
- Contraindication to scanning, including but not limited to ferromagnetic metal in the body, claustrophobia, inability to lie still or otherwise tolerate being in the scanner.
- Pregnant women must be excluded from the imaging component of the study due to unknown but possible risk of fetal exposure to the scanner. Women of child-bearing potential will take a confidential pregnancy test immediately prior to each scan session.
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Yoga/meditation
A 6-week yoga/meditation intervention.
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A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions.
This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.
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Sin intervención: Wait list
A wait list control period.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of conducting a yoga intervention study
Periodo de tiempo: At the clinic visit immediately following the yoga class session
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The feasibility will be determined by the completion rates of the intervention.
If fewer than 50% of subjects complete the intervention, it will be deemed unfeasible in the current format.
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At the clinic visit immediately following the yoga class session
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in subject self-rated fatigue
Periodo de tiempo: Through study completion, approximately 22 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue scale for MS: 8-item measure of fatigue.
Scale range 8 to 40.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated self-efficacy
Periodo de tiempo: Through study completion, approximately 22 weeks
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Liverpool Self-efficacy scale: 17-item measure of self-efficacy.
Scale range 17 to 68.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated anxiety
Periodo de tiempo: Through study completion, approximately 22 weeks
|
Neuro-Quality of Life (QOL) v1.0 Anxiety - Short Form: 8-item measure of anxiety.
Scale range 8 to 40.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
|
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Change in subject self-rated depression
Periodo de tiempo: Through study completion, approximately 22 weeks
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Neuro-Quality of Life (QOL) v1.0 Depression - Short Form: 8-item measure of depression.
Scale range 8 to 40.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated positive affect
Periodo de tiempo: Through study completion, approximately 22 weeks
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Neuro-Quality of Life (QOL) v1.0 Positive affect and well-being - Short form: 9-item measure of positive affect and well-being.
Scale range 8 to 48.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject cognition/processing speed
Periodo de tiempo: Through study completion, approximately 22 weeks
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Single Digit Modalities Test: Measure of cognition/processing speed.
Score range 0 to 110.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated sleep disturbance
Periodo de tiempo: Through study completion, approximately 22 weeks
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Neuro-QOL v1.0 Sleep disturbance - Short Form: 8-item measure of sleep disturbance.
Scale range 8 to 40.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated pain interference
Periodo de tiempo: Through study completion, approximately 22 weeks
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Patient-Reported Outcomes Measurement Information System (PROMIS) v1.0 Pain Interference - Short Form 6b: 6-item measure of sleep disturbance.
Scale range 6 to 30.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated quality of life
Periodo de tiempo: Through study completion, approximately 22 weeks
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Multiple Sclerosis Impact Scale (MSIS-29): 29-item measure of quality of life.
Scale range 29 to 145.
A lower score represents a better outcome.
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Through study completion, approximately 22 weeks
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Change in subject self-rated cognitive function
Periodo de tiempo: Through study completion, approximately 22 weeks
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Neuro-Quality of Life (QOL) v2.0 Cognitive Function - Short Form: 8-item measure of cognitive function.
Scale range 8 to 48.
A higher score represents a better outcome.
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Through study completion, approximately 22 weeks
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Satisfaction rating of 6-week yoga program on a scale of 1 - 10
Periodo de tiempo: At the clinic visit immediately following the yoga/meditation class session
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Satisfaction scale: Subjects will rate their satisfaction with the yoga program on a scale of 1 - 10. Higher scores indicate a better rating.
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At the clinic visit immediately following the yoga/meditation class session
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 (Actual)
1 de julio de 2019
Finalización primaria (Actual)
30 de diciembre de 2019
Finalización del estudio (Actual)
30 de diciembre de 2019
Fechas de registro del estudio
Enviado por primera vez
23 de enero de 2019
Primero enviado que cumplió con los criterios de control de calidad
30 de enero de 2019
Publicado por primera vez (Actual)
4 de febrero de 2019
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
4 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D19058
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .