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REmote Virtual Inspiration: Vitality and Energy (REVIVE)

2026年8月4日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

280

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Arizona
      • Phoenix、Arizona、アメリカ、85004
        • 募集
        • Arizona State University
        • コンタクト：
        • 主任研究者：
          • Rebecca E Lee, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：独身

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
行動：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.
アクティブコンパレータ：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.
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Waist Circumference (cm)
時間枠：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)
時間枠：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)
時間枠：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)

二次結果の測定

結果測定
メジャーの説明
時間枠
Perceived Stress Scale (PSS-10) Total Score
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Arizona State University

協力者

National Institute on Aging (NIA)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月1日

一次修了 (推定)

2030年8月30日

研究の完了 (推定)

2030年8月30日

試験登録日

最初に提出

2026年6月17日

QC基準を満たした最初の提出物

2026年6月23日

最初の投稿 (実際)

2026年6月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年8月5日

QC基準を満たした最後の更新が送信されました

2026年8月4日

最終確認日

2026年8月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • STUDY00023587
  • R01AG088032-01A1 (米国 NIH グラント/契約)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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