CClinicalTrials.gg
CompletedNCT05279989Updated Feb 2, 2023

Healthy Weight and Stress Management Study

An interventional study of Seated Tai Chi Qigong and Health Information Videos in Physical Disability, Obesity and Muscle Weakness, sponsored by Arizona State University. Completed at 1 site in United States. Open to female participants aged 35 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-02-02.

Sponsored by Arizona State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
35 Years to 64 Years
Sex
Female
01

Study summary

Approximately 1 in 10 mid-life (age 35-64) Americans have mobility impairing disabilities. People with mobility impairing disabilities are defined using the World Health Organization criteria: community living adults with mobility impairment (e.g., amputation, spinal cord injury). Women with mobility impairing disabilities often struggle with stress, abdominal fat (measured as waist circumference), lack of muscle tissue (measured as handgrip strength) and high cardiometabolic risk. This study investigates the usefulness, acceptability, and effectiveness of two strategies to reduce stress, improve health habits, reduce abdominal fat and increase muscle tissue in mid-life women with mobility impairments. These strategies involve either gentle stretching and strengthening exercises or watching informative videos.

Read the detailed description

About 1 in 10 mid-life (age 35-64) Americans have mobility impairing disabilities, steadily increasing due to medical and technological innovations. People with mobility impairing disabilities (PMI) are defined using the World Health Organization criteria, as community living adults with mobility impairment (e.g., amputation, spinal cord injury). Mid-life is a critical time for people to improve their current functioning and enhance healthy aging, by improving emotional health and increasing physical activity (PA). A review showed PA improves emotional and physical health among PMI. PMI have unique challenges to meeting PA guidelines; innovative strategies are needed to achieve emotional and physical benefits for optimal health and aging.

The higher prevalence of daily stress encountered by mid-life PMI is linked to emotional health and abdominal fat (cardiometabolic disease risk) that can lead to premature mortality. This is especially so for women with mobility impairment (WMI) who have higher prevalence of excess body fat, higher cardiometabolic risk, and are not eligible for most interventions that involve PA. PA interventions also increase muscle mass, which helps to prevent cardiometabolic conditions. Although vigorous PA may not be well-suited for WMI, lighter intensity PA such as Tai Chi, Qigong and Yoga-also called meditative movement-adapted for seated practice, are a possible solution.

Tai Chi and Qigong have been tested in non-impaired populations. Our work combines these two forms of low-to-moderate PA meditative movement, Tai Chi and Qigong (TCQ), in a mind-body practice. Our research, and others', show that TCQ consistently shows strong improvement in women in depressive symptoms, anxiety, emotional eating, and sleep quality-all contributing to excess abdominal fat (measured as waist circumference), improved muscle tissue (measured as handgrip strength) and strongly associated with cardiometabolic risk. Conventional health assessment strategies do not always work well for PMI; recent innovations have yielded scalable, low-contact assessment. We have demonstrated robust recruitment, reliable questionnaire administration and strong intervention implementation expertise via social media, video sharing, and gaming platforms.

Aim 1: Assess the potential efficacy of TCQ to reduce waist circumference and increase handgrip strength compared to controls from T1 to T2 and sustain this change to T3 and T4 when compared to control.

Aim 2: Assess the potential efficacy of TCQ to reduce stress-related behaviors (depressive symptoms, anxiety, emotional eating, and sleep) that impact abdominal fat and strength when compared to control.

Aim 3: Evaluate the feasibility and acceptability of an online delivered TCQ intervention in women with mobility impairments.

02

Conditions studied

  • Physical Disability
  • Obesity
  • Muscle Weakness
  • Anxiety
  • Depression

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Keywords

  • Mobility impairment
  • Tai Chi
  • Stress Management
  • Obesity
03

In context

Muscle Weakness

601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.

This study's enrollment of 25 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Arizona State University is the lead sponsor of 234 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 64 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Community dwelling.
  • Female.
  • Age 35-64.
  • Waist circumference >83 cm (\~35 inches).
  • Have a self-reported mobility impairment due to a chronic (>1 year).
  • Physically disabling condition (regularly using an assistive device).
  • Access to an email address and a working phone, mobile device, or personal computer or device with a high-speed internet connection.
  • Understand spoken and written English and be willing to be randomized.
  • Willing to engage in the intervention for 12 weeks, be available for two Zoom calls for data collection at T1, T2, T3, and T4 (Week 1, Week 4, Week 8, and Week 12).

Exclusion criteria

Exclusion Criteria:

  • People with full mobility.
  • People who have been regularly practicing (e.g., ≥2 or more times per month for the past 6 months) any form of meditative movement including, but not limited to, Yoga, Tai Chi or Qigong.
  • Pregnant, lactating, or planning to become pregnant in the next 6 months,
  • Participants outside of the age range will be excluded from participation.
  • Adults unable to consent and prisoners will be excluded.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Seated Tai Chi Qigong

    Participants will receive daily text messages and emails to distribute videos and record which sessions were completed. Participants can participate in 10-, 20-, or 30- min TCQ practices. Total weekly practice time will be recommended between 50-150 minutes/week (\~10-30 min/day on most days). A library of existing TCQ videos will be used. All videos will demonstrate seated practice with discussions on how to accommodate mobility limitations of various types.

    Other: Seated Tai Chi Qigong

  • Placebo comparator
    Control

    The control arm will receive text messages and emails with links to health information videos for the same time lengths as the intervention group. Existing video content will be reviewed and adapted to assure avoidance of topics that can impact outcome variables.

    Other: Health Information Videos

Interventions

  • OtherSeated Tai Chi Qigong

    Participants will receive seated Tai Chi Qigong videos.

  • OtherHealth Information Videos

    Participants will receive videos of health information.

06

What researchers measure

Primary outcomes

  1. Waist Circumference assessed by measuring tape

    Waist Circumference assessed by measuring tape

    Time frame: Baseline

  2. Waist Circumference assessed by measuring tape

    Waist Circumference (cm) assessed by measuring tape

    Time frame: Week 4

  3. Waist Circumference measured by measuring tape

    Waist Circumference (cm) assessed by measuring tape

    Time frame: Week 8

  4. Waist Circumference measured by measuring tape

    Waist Circumference (cm) assessed by measuring tape

    Time frame: Week 12

  5. Handgrip strength measured by isokinetic handgrip dynamometry

    Weight (kg) resisted measured by handgrip dynamometer

    Time frame: Baseline

  6. Handgrip strength measured by isokinetic handgrip dynamometry

    Weight (kg) resisted measured by handgrip dynamometer

    Time frame: Week 4

  7. Handgrip strength measured by isokinetic handgrip dynamometry

    Weight (kg) resisted measured by handgrip dynamometer

    Time frame: Week 8

  8. Handgrip strength measured by isokinetic handgrip dynamometry

    Weight (kg) resisted measured by handgrip dynamometer

    Time frame: Week 12

  9. Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale

    Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.

    Time frame: Baseline

  10. Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale

    Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.

    Time frame: Week 12

  11. Anxiety assessed by Generalized Anxiety Disorder 7-item Scale

    Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.

    Time frame: Baseline

  12. Anxiety assessed by Generalized Anxiety Disorder 7-item Scale

    Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome

    Time frame: Week 12

Secondary outcomes

  1. Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor

    Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating

    Time frame: Baseline

  2. Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor

    Mindful Eating Questionnaire - 5 Factor Score scored on a scale of 1-4, with higher scores signifies more mindful eating

    Time frame: Week 12

  3. Sleep Quality assessed by the Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality

    Time frame: Baseline

  4. Sleep Quality assessed by Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality

    Time frame: Week 4

  5. Sleep Quality assessed by Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality

    Time frame: Week 8

  6. Sleep Quality assessed by Pittsburgh Sleep Quality Index

    Pittsburgh Sleep Quality Index Score, scored on a scale of 0-21, with higher scores indicating poorer sleep quality

    Time frame: Week 12

  7. Food Consumption Frequency assessed by the Dietary Screener Questionnaire

    Dietary Screener Questionnaire responses measuring food consumption frequency

    Time frame: Baseline

  8. Food Consumption Frequency assessed by the Dietary Screener Questionnaire

    Dietary Screener Questionnaire responses measuring food consumption frequency

    Time frame: Week 12

  9. Physical Functioning assessed by the Short-Form Health Survey

    The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function

    Time frame: Baseline

  10. Physical Functioning assessed by The Short-Form Health Survey

    The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater physical function

    Time frame: Week 12

  11. Well-Being assessed by the Short-Form Health Survey

    The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being

    Time frame: Baseline

  12. Well-Being assessed by the Short-Form Health Survey

    The Short-Form Health Survey Score scored 0-100, with higher scores indicating greater well-being

    Time frame: Week 12

07

Study locations

1 site
  • Edson College of Nursing and Health Innovation
    Phoenix, Arizona 85004, United States
08

References and documents

Publications

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Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05279989
Lead sponsor
Arizona State University
Responsible party
Sponsor
First posted
Mar 15, 2022
Start date
Dec 1, 2021
Primary completion
Dec 22, 2022
Completion
Dec 22, 2022
Last update
Feb 2, 2023

Study contacts

Rebecca E Lee, PhD
principal investigator · Arizona State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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