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NCT Number: NCT07675681

REmote Virtual Inspiration: Vitality and Energy

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.

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Key information

Age range

35 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Location status: Recruiting

Location contact

Rebecca E Lee, PhD

CONTACT

[email protected]

6024960910

Rebecca E Lee, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Accesible Tai Chi/Qigong (TCQ)

Behavioral

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.

Health Education Videos (HEV)

Behavioral

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.

Primary outcomes

  1. Waist Circumference (cm)

    Time frame: 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.

  2. High-Frequency Heart Rate Variability (HF Power)

    Time frame: 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.

  3. Diurnal Salivary Cortisol Area Under the Curve (AUCg)

    Time frame: 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.

Secondary outcomes

  1. Perceived Stress Scale (PSS-10) Total Score

    Time frame: 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.

  2. Emotion Regulation Questionnaire (ERQ) Cognitive Reappraisal Score

    Time frame: 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.

  3. Center for Epidemiologic Studies Depression Scale (CES-D-10) Total Score

    Time frame: 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.

  4. Generalized Anxiety Disorder-7 (GAD-7) Total Score

    Time frame: 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.

  5. Mindful Eating Questionnaire (MEQ) Emotional Eating Subscale Score

    Time frame: 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.

  6. Insomnia Severity Index (ISI) Total Score

    Time frame: 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.

  7. PROMIS Sleep Disturbance Short Form T-Score

    Time frame: 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.

  8. Sleep Efficiency Measured by Oura Ring

    Time frame: 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.

  9. Sleep Diary

    Time frame: 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.

  10. Check And Line Questionnaire (CALQ)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rebecca E Lee, PhD

CONTACT

[email protected]

6024960910

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Improving Cardiometabolic Health With Meditative Movement in Mobility Impaired Women

Acronym: REVIVE

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Jun 30, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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