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REmote Virtual Inspiration: Vitality and Energy (REVIVE)

tiistai 4. elokuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

280

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

  • Yhdysvallat
    • Arizona
      • Phoenix, Arizona, Yhdysvallat, 85004
        • Rekrytointi
        • Arizona State University
        • Ottaa yhteyttä:
        • Päätutkija:
          • Rebecca E Lee, PhD

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

  • Aikuinen

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.
Käyttäytyminen: 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.
Käyttäytyminen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Waist Circumference (cm)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Perceived Stress Scale (PSS-10) Total Score
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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.

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Arizona State University

Yhteistyökumppanit

National Institute on Aging (NIA)

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Tiistai 1. syyskuuta 2026

Ensisijainen valmistuminen (Arvioitu)

Perjantai 30. elokuuta 2030

Opintojen valmistuminen (Arvioitu)

Perjantai 30. elokuuta 2030

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 17. kesäkuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Tiistai 23. kesäkuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Tiistai 30. kesäkuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 5. elokuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Tiistai 4. elokuuta 2026

Viimeksi vahvistettu

Lauantai 1. elokuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muut tutkimustunnusnumerot

  • STUDY00023587
  • R01AG088032-01A1 (Yhdysvaltain NIH-apuraha/sopimus)

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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.

IPD-jaon aikakehys

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

IPD-jaon käyttöoikeuskriteerit

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.

IPD-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

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