REmote Virtual Inspiration: Vitality and Energy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-64
SponsorArizona State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Accesible Tai Chi/Qigong (TCQ)
BehavioralA 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)
BehavioralA 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.
Treatment groups
280 Participants
are divided into 2 treatment groupsGroup A: Accesible Tai Chi/QigongExperimental treatment 1 intervention
Group B: Health Education Videos (HEV)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)2
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.
Time frame
Baseline 2-week assessment period, Week 15 (post-intervention) 2-week assessment period, and Week 29 (follow-up) 2-week assessment period.3
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.
Time frame
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)Secondary outcomes
1
Perceived Stress Scale (PSS-10) Total Score
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.
Time frame
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)2
Emotion Regulation Questionnaire (ERQ) Cognitive Reappraisal Score
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.
Time frame
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)3
Center for Epidemiologic Studies Depression Scale (CES-D-10) Total Score
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.
Time frame
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)4
Generalized Anxiety Disorder-7 (GAD-7) Total Score
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.
Time frame
Baseline (T1), Week 15 (T2; post-intervention), and Week 29 (T3; follow-up)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Arizona State University
Lead sponsor
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov