REmote Virtual Inspiration: Vitality and Energy

NCT07675681 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00023587R01AG088032-01A1
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Implementation Science; Women Health; Disability Physical; Meditation; Tai Chi

Keywords

Mobility Impairment; Tai Chi/Qigong; Cardiometabolic Health; Women with Disabilities; Stress Regulation; Sleep Health

Outcome Measures

Primary Outcomes (3)

• Waist Circumference (cm)

  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)

  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)

  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)

Secondary Outcomes (10)

• Perceived Stress Scale (PSS-10) Total Score

  Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)

• Emotion Regulation Questionnaire (ERQ) Cognitive Reappraisal Score

  Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)

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

  Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)

• Generalized Anxiety Disorder-7 (GAD-7) Total Score

  Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)

• Mindful Eating Questionnaire (MEQ) Emotional Eating Subscale Score

  Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)

Study Arms (2)

Accesible Tai Chi/Qigong

EXPERIMENTAL

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.

Behavioral: Accesible Tai Chi/Qigong (TCQ)

Health Education Videos (HEV)

ACTIVE COMPARATOR

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.

Behavioral: Health Education Videos (HEV)

Interventions

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.

Health Education Videos (HEV)

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.

Accesible Tai Chi/Qigong

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: The study focuses on women because women with mobility impairments experience disproportionately high rates of cardiometabolic risk factors, stress, and sleep disturbances, and because the intervention was specifically designed to address these health disparities in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arizona State University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Central Study Contacts

Rebecca E Lee, PhD

CONTACT

6024960910; releephd@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2026
• First Posted: June 30, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 30, 2030
• Study Completion (Estimated): August 30, 2030
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study protocol and statistical Analysis Plan will be available by December 2030 with no end date.
• Access Criteria: De-identified individual participant data underlying published results may be made available to qualified researchers upon reasonable request. Requests will be reviewed by the study investigators and Arizona State University to ensure participant confidentiality, compliance with institutional policies, and appropriate scientific use. Data use agreements may be required prior to data release.

Locations

US (1)