REmote Virtual Inspiration: Vitality and Energy

Официальное название

Improving Cardiometabolic Health With Meditative Movement in Mobility Impaired Women

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Accesible Tai Chi/Qigong (TCQ)
  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.
• Поведенческое Health Education Videos (HEV)
  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.

Первичные конечные точки

• Waist Circumference (cm) [Срок оценки: Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)]
• High-Frequency Heart Rate Variability (HF Power) [Срок оценки: 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) [Срок оценки: Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)]

Вторичные конечные точки (10)

• Perceived Stress Scale (PSS-10) Total Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Emotion Regulation Questionnaire (ERQ) Cognitive Reappraisal Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Center for Epidemiologic Studies Depression Scale (CES-D-10) Total Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Generalized Anxiety Disorder-7 (GAD-7) Total Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Mindful Eating Questionnaire (MEQ) Emotional Eating Subscale Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Insomnia Severity Index (ISI) Total Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• PROMIS Sleep Disturbance Short Form T-Score [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Sleep Efficiency Measured by Oura Ring [Срок оценки: Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)]
• Sleep Diary [Срок оценки: Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.]
• Check And Line Questionnaire (CALQ) [Срок оценки: Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Arizona State University — Phoenix

Идентификаторы

NCT: NCT07675681 · STUDY00023587 · R01AG088032-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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