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REmote Virtual Inspiration: Vitality and Energy (REVIVE)

4 agosto 2026 aggiornato da: Rebecca Lee, Arizona State University

Improving Cardiometabolic Health With Meditative Movement in Mobility Impaired Women

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

280

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • Arizona
      • Phoenix, Arizona, Stati Uniti, 85004
        • Reclutamento
        • Arizona State University
        • Contatto:
        • Investigatore principale:
          • Rebecca E Lee, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comparatore attivo: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Waist Circumference (cm)
Lasso di tempo: 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.
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)
High-Frequency Heart Rate Variability (HF Power)
Lasso di tempo: 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.
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)
Lasso di tempo: 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.
Baseline (T1), Post-Intervention (T2, Week 15), and Follow-Up (T3, Week 29)

Misure di risultato secondarie

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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Arizona State University

Collaboratori

National Institute on Aging (NIA)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

30 agosto 2030

Completamento dello studio (Stimato)

30 agosto 2030

Date di iscrizione allo studio

Primo inviato

17 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

23 giugno 2026

Primo Inserito (Effettivo)

30 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • STUDY00023587
  • R01AG088032-01A1 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Data collected as part of this project will be de-identified and made available on public websites that may be shared with investigators working under an institution with a Federal Wide Assurance (FWA). As there is no specific data sharing repository for the funding agency, the investigators will identify possible other repositories that may be appropriate to use. For whatever NIH-funded repository is advised to be used, the investigators acknowledge that this repository will have policies and procedures in place that will provide data access to qualified researchers, consistent with NIH data sharing policies and applicable laws and regulations. Data will be deposited to the repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award.

Periodo di condivisione IPD

Study protocol and statistical Analysis Plan will be available by December 2030 with no end date.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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