REmote Virtual Inspiration: Vitality and Energy (REVIVE)
Improving Cardiometabolic Health With Meditative Movement in Mobility Impaired Women
REVIVE is a randomized controlled trial designed to evaluate the effects of a remotely delivered seated Tai Chi/Qigong (TCQ) intervention on cardiometabolic health, stress, sleep, and psychological well-being among women with mobility impairments.
Women with mobility impairments experience higher rates of obesity, cardiometabolic disease, chronic stress, sleep disturbances, and mental health concerns compared with women without disabilities. Limited access to accessible physical activity programs and barriers to participation in traditional exercise interventions contribute to these health disparities. Tai Chi and Qigong are gentle mind-body practices that may improve physical and psychological health through movement, breathing, and mindfulness techniques and can be adapted for individuals with limited mobility.
Participants will be randomized to either a seated Tai Chi/Qigong intervention or a health education video control condition. During the 12-week intervention phase, participants will receive daily video-based content delivered remotely. Participants assigned to the Tai Chi/Qigong group will engage in seated meditative movement practices, while participants assigned to the control group will receive health and wellness education videos unrelated to physical activity or nutrition behavior change.
Outcomes will be assessed remotely at baseline, post-intervention, and follow-up. Primary outcomes include waist circumference and indicators of physiological stress regulation, including heart rate variability and salivary cortisol. Secondary outcomes include perceived stress, emotion regulation, depression, anxiety, emotional eating, sleep quality, and sleep disturbance. Additional measures collected through wearable technology, sleep diaries, questionnaires, and biological samples will be used to examine potential behavioral, psychological, and physiological mechanisms underlying intervention effects.
The findings from this study will contribute to the development of accessible, scalable, and evidence-based health promotion interventions designed to improve cardiometabolic health and overall well-being among women with mobility impairments.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
The REVIVE study is a fully remote, two-arm randomized controlled trial designed to test a seated Tai Chi/Qigong intervention adapted for women with mobility impairments. The study addresses the need for accessible, home-based interventions that can support health and well-being among individuals who may experience barriers to traditional in-person physical activity programs.
Participants complete all study activities from home over approximately 30 weeks. After screening and baseline procedures, participants are randomized to one of two study conditions: a seated Tai Chi/Qigong intervention or a health education video control condition. The study includes a baseline assessment period, a 12-week guided intervention phase, a post-intervention assessment period, a 12-week unprompted phase, and a final follow-up assessment period.
During the guided intervention phase, participants receive daily video-based content. Participants assigned to the Tai Chi/Qigong condition receive seated practice videos that include gentle movements, breathing exercises, mindfulness, relaxation, body awareness, and meditative movement practices. Videos include shorter and longer options to support flexibility and accommodate participant preferences, and schedules.
Participants assigned to the health education video control condition receive daily wellness education videos delivered with the same frequency and format. Control videos address general wellness topics but do not include meditative movement, structured exercise instruction, or physical activity behavior change strategies.
Study assessments are conducted remotely using online surveys, wearable technology, sleep diaries, remote measurement procedures, and at-home saliva collection. Study staff provide training and online support to help participants complete study activities and assessments from home.
REVIVE will evaluate whether a remotely delivered, seated Tai Chi/Qigong intervention adapted for women with mobility impairments can improve cardiometabolic and stress-related health outcomes. The study will also examine potential biological, psychological, and behavioral pathways that may explain intervention effects. Findings may inform future clinical and community-based programs designed to improve health and quality of life among women with mobility impairments.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Rebecca E Lee, PhD
- Número de teléfono: 6024960910
- Correo electrónico: releephd@yahoo.com
Ubicaciones de estudio
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85004
- Reclutamiento
- Arizona State University
-
Contacto:
- Rebecca E Lee, PhD
- Número de teléfono: 6024960910
- Correo electrónico: releephd@yahoo.com
-
Investigador principal:
- Rebecca E Lee, PhD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Self-identify as a woman.
- Age 35-64 years.
- Mobility impairment lasting at least 1 year.
- Regular use of a mobility aid (e.g., wheelchair, scooter, walker, cane, crutches, or other assistive device).
- Community dwelling.
- Able to demonstrate sufficient upper-extremity mobility to participate in seated Tai Chi/Qigong activities.
- Access to a smartphone, tablet, or computer with internet access.
- Willing to wear a study-provided wearable device and complete study assessments.
- Reside in the United States.
- Waist circumference ≥ 33 inches (84 cm).
- Perceived Stress Scale (PSS) score ≥ 15.
- Insomnia Severity Index (ISI) score ≥ 8.
- Emotional eating indicated by a score < 3 on the Mindful Eating Questionnaire (MEQ) Emotional Response subscale.
- Able to understand written and spoken English.
- Able to provide informed consent.
- Able to provide healthcare provider approval for participation.
Exclusion Criteria:
- Medical conditions that would make participation unsafe, as determined during screening.
- Inability to safely perform seated upper-body movements.
- Current participation in a structured Tai Chi, Qigong, or similar meditative movement program.
- Pregnancy, lactation, or plans to become pregnant during the study period.
- Cognitive, visual, auditory, or other impairments that would preclude completion of study procedures.
- Implanted cardiac devices or implanted electronic devices that interfere with physiologic measurements.
- Severe arrhythmia, left ventricular assist device (LVAD), or other conditions that interfere with heart rate variability assessment.
- Use of sleep medications three or more times per week.
- Medical conditions or medications that substantially affect autonomic nervous system activity, sleep, or stress-related outcomes.
- Uncontrolled cardiovascular, neurological, psychiatric, or other serious medical conditions that would preclude safe participation.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Accesible Tai Chi/Qigong
Participants receive a 12-week remotely delivered seated Tai Chi/Qigong intervention consisting of daily video-based meditative movement sessions adapted for women with mobility impairments.
|
A remotely delivered seated Tai Chi/Qigong intervention designed for women with mobility impairments.
Participants receive daily video-based sessions that incorporate seated meditative movement, breathing exercises, mindfulness, relaxation techniques, and body awareness practices.
Short and long session options are available throughout the 12-week intervention period.
|
|
Comparador activo: Health Education Videos (HEV)
Participants receive a 12-week remotely delivered health education program consisting of daily video-based wellness education content on a variety of health-related topics.
|
A remotely delivered health education program consisting of daily video-based wellness education content provided over 12 weeks.
Topics include healthy aging, preventive healthcare, chronic disease awareness, communication with healthcare providers, and other general wellness topics.
The program does not include Tai Chi, Qigong, exercise instruction, or physical activity behavior change content.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Waist Circumference (cm)
Periodo de tiempo: Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)
|
Change in waist circumference measured in centimeters using a standardized Zoom-guided measurement protocol.
Waist circumference is used as an indicator of abdominal adiposity and cardiometabolic risk.
|
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)
|
|
High-Frequency Heart Rate Variability (HF Power)
Periodo de tiempo: Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
Change in nocturnal high-frequency (HF) heart rate variability power measured using the Oura Ring.
Higher HF power indicates greater parasympathetic nervous system activity and autonomic balance.
HF power is the primary heart rate variability parameter used to assess physiological stress regulation.
|
Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
|
Diurnal Salivary Cortisol Area Under the Curve (AUCg)
Periodo de tiempo: Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)
|
Change in diurnal salivary cortisol area under the curve with respect to ground (AUCg), calculated from saliva samples collected over two days with three samples per day.
Lower AUCg values indicate reduced hypothalamic-pituitary-adrenal (HPA) axis activation and biological stress.
|
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Perceived Stress Scale (PSS-10) Total Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in perceived stress measured using the 10-item Perceived Stress Scale (PSS-10).
Scores range from 0 to 40, with higher scores indicating greater perceived stress.
The primary reported value will be the total score.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Emotion Regulation Questionnaire (ERQ) Cognitive Reappraisal Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in cognitive reappraisal measured using the Emotion Regulation Questionnaire (ERQ).
Scores range from 1 to 7, with higher scores indicating greater use of cognitive reappraisal strategies.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Center for Epidemiologic Studies Depression Scale (CES-D-10) Total Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in depressive symptoms measured using the 10-item CES-D.
Scores range from 0 to 30, with higher scores indicating greater depressive symptom severity.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Generalized Anxiety Disorder-7 (GAD-7) Total Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in anxiety symptoms measured using the Generalized Anxiety Disorder-7 (GAD-7).
Scores range from 0 to 21, with higher scores indicating greater anxiety severity.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Insomnia Severity Index (ISI) Total Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in insomnia symptoms measured by the Insomnia Severity Index (ISI).
The ISI is a 7-item self-report questionnaire with total scores ranging from 0 to 28.
Higher scores indicate greater insomnia severity.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Sleep Efficiency Measured by Oura Ring
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in sleep efficiency (%) measured objectively using the Oura Ring wearable device.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Sleep Diary
Periodo de tiempo: Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
Average sleep outcomes derived from the 14-day Consensus Sleep Diary completed during each assessment period.
|
Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
|
Mindful Eating Questionnaire (MEQ) Emotional Eating Subscale Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in emotional eating measured using the Emotional Eating subscale of the Mindful Eating Questionnaire (MEQ).
Subscale scores range from 1 to 4, with higher scores indicating lower levels of emotional eating and more mindful eating behaviors.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
PROMIS Sleep Disturbance Short Form T-Score
Periodo de tiempo: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
Change in sleep disturbance measured using the PROMIS Sleep Disturbance Short Form.
Raw scores range from 8 to 40 and are converted to standardized T-scores, with higher T-scores indicating greater sleep disturbance.
|
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)
|
|
Check And Line Questionnaire (CALQ)
Periodo de tiempo: Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
Average daily minutes of self-reported physical activity will be measured using the Check and Line Questionnaire (CALQ) over the 14-day assessment period.
Participants will report total daily or weekly minutes of light, moderate, and vigorous physical activity, or any combination of these, rounded to the nearest 15-minute increment.
|
Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Otros números de identificación del estudio
- STUDY00023587
- R01AG088032-01A1 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
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. .