Purpose

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

Eligibility

Eligible Ages
Between 35 Years and 64 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Behavioral: 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.
Active Comparator
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.
  • Behavioral: 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.

Recruiting Locations

Arizona State University
Phoenix, Arizona 85004
Contact:
Rebecca E Lee, PhD
602-496-0910
releephd@yahoo.com

More Details

Status
Recruiting
Sponsor
Arizona State University

Study Contact

Rebecca E Lee, PhD
6024960910
releephd@yahoo.com

Detailed Description

Women with mobility impairments experience disproportionately high rates of obesity, cardiometabolic disease, chronic stress, sleep disturbances, depression, anxiety, and reduced quality of life compared with women without disabilities. Despite these health disparities, accessible physical activity and stress management interventions specifically designed for women with mobility impairments remain limited. Barriers such as transportation challenges, inaccessible facilities, pain, fatigue, environmental constraints, and lack of disability-adapted programming often prevent participation in traditional exercise interventions. Consequently, there is a critical need for accessible, scalable, home-based interventions that can improve both physical and psychological health outcomes in this underserved population. The purpose of the REVIVE study is to evaluate the effectiveness of a remotely delivered seated Tai Chi/Qigong (TCQ) intervention for improving cardiometabolic health and stress-related outcomes among women with mobility impairments. Tai Chi and Qigong are mind-body practices that combine gentle movements, controlled breathing, meditation, and focused attention. These practices have demonstrated beneficial effects on stress reduction, emotional regulation, sleep quality, cardiovascular function, and overall well-being in a variety of populations. However, few studies have examined their effectiveness among women with mobility impairments, particularly when delivered remotely and adapted for seated participation. This study is a two-arm randomized controlled trial conducted entirely remotely across the United States. Eligible participants are women aged 35-64 years with a long-term mobility impairment who regularly use a mobility aid and meet study eligibility criteria. Following screening and baseline assessments, participants will be randomly assigned to either a seated Tai Chi/Qigong intervention group or a health education video (HEV) control group. The study duration is approximately 30 weeks and consists of three assessment periods. Baseline assessments (T1) occur over approximately three weeks and include an initial run-in period followed by physiological and behavioral assessments. Participants then complete a 12-week intervention phase, followed by post-intervention assessments (T2). After T2, participants enter a 12-week maintenance phase during which they may continue engaging with intervention materials independently. Follow-up assessments (T3) are completed at the end of the maintenance period. Participants randomized to the Tai Chi/Qigong condition will receive daily access to seated Tai Chi/Qigong video sessions adapted for individuals with mobility limitations. Videos include both shorter and longer practice options to accommodate participant preferences and daily schedules. The intervention emphasizes gentle upper-body and seated movements, breathing exercises, mindfulness, relaxation, body awareness, and meditative movement practices. Participants are encouraged to engage in the assigned activities daily throughout the 12-week intervention period. Participants randomized to the health education video control condition will receive daily wellness education videos matched in frequency and delivery format. Topics may include healthy aging, stress awareness, chronic disease prevention, communication with healthcare providers, preventive care, safety, and other general wellness topics. Control content is designed to provide health information without including meditative movement, structured exercise instruction, or behavior change strategies related to physical activity. All intervention materials are delivered remotely through online video platforms, allowing participation from home without the need for travel. Participants also receive regular reminders and motivational messages designed to support engagement and adherence throughout the study. The primary objective of the study is to determine whether participation in the seated Tai Chi/Qigong intervention improves cardiometabolic health compared with the health education control condition. The primary outcome is waist circumference, a clinically important indicator of central adiposity and cardiometabolic risk. Additional primary outcomes include physiological indicators of stress regulation, including heart rate variability (HRV) and salivary cortisol. Heart rate variability is measured using wearable technology and serves as a noninvasive indicator of autonomic nervous system function and stress resilience. Salivary cortisol samples are collected remotely by participants. Together, these physiological measures provide objective indicators of stress regulation and potential mechanisms through which meditative movement may influence health outcomes. Secondary outcomes include perceived stress and emotion regulation, depressive symptoms and anxiety, emotional eating and sleep quality. Sleep outcomes are assessed through a combination of wearable device data, sleep diaries, and validated self-report questionnaires. Participants wear an Oura Ring during each assessment period to collect objective measures of sleep, physical activity, and heart rate variability. Additional data are collected through online surveys, remote waist circumference measurements, daily sleep diaries, and saliva collection procedures completed at home. Study staff provide training and support for all remote assessments. A secondary objective of the study is to examine potential mechanisms that explain intervention effects. The study evaluates whether improvemens in stress regulation, emotional functioning, sleep, and health behaviors mediate changes in cardiometabolic outcomes. By simultaneously examining biological, psychological, and behavioral pathways, the study seeks to better understand how meditative movement interventions influence health among women with mobility impairments. This research addresses a significant public health need by focusing on an underserved population that experiences substantial health disparities and limited access to evidence-based interventions. Results from the study may inform future clinical and community-based programs aimed at reducing cardiometabolic risk, improving stress regulation, enhancing sleep quality, and promoting overall health and well-being among women with mobility impairments. The long-term goal of this research is to develop scalable, accessible, and sustainable interventions that improve health outcomes and quality of life for individuals living with mobility impairments and other physical disabilities.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.