Physical DisabilityNCT05279989
Healthy Weight and Stress Management Study
A study testing Seated Tai Chi Qigong and Health Information Videos in people with Physical Disability and Obesity, run by Arizona State University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Physical Disability, Obesity, Muscle Weakness
- What is being tested?
- Seated Tai Chi Qigong and Health Information Videos
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 22 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Show all 9Show fewer
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Edson College of Nursing and Health Innovation
Phoenix, Arizona, 85004
About this study
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.
- Conditions
- Physical Disability, Obesity, Muscle Weakness, Anxiety, Depression
- Being tested
- Seated Tai Chi Qigong, Health Information Videos
- Keywords
- Mobility impairment, Tai Chi, Stress Management, Obesity
- Medical subject headings
- Obesity, Muscle Weakness, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seated Tai Chi QigongOther
Participants will receive seated Tai Chi Qigong videos.
Health Information VideosOther
Participants will receive videos of health information.
| Study group | Role | What they receive |
|---|---|---|
| Seated Tai Chi Qigong | Experimental | 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. Receives: Other: Seated Tai Chi Qigong |
| Control | Placebo comparator | 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. Receives: Other: Health Information Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Waist Circumference assessed by measuring tape
Waist Circumference assessed by measuring tape
Measured: Baseline
Waist Circumference assessed by measuring tape
Waist Circumference (cm) assessed by measuring tape
Measured: Week 4
Waist Circumference measured by measuring tape
Waist Circumference (cm) assessed by measuring tape
Measured: Week 8
Waist Circumference measured by measuring tape
Waist Circumference (cm) assessed by measuring tape
Measured: Week 12
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Measured: Baseline
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Measured: Week 4
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Measured: Week 8
Handgrip strength measured by isokinetic handgrip dynamometry
Weight (kg) resisted measured by handgrip dynamometer
Measured: Week 12
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.
Measured: Baseline
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.
Measured: Week 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.
Measured: Baseline
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
Measured: Week 12
Secondary outcomes (12)
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
Measured: Baseline
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
Measured: Week 12
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
Measured: Baseline
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
Measured: Week 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
Measured: Week 8
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
Measured: Week 12
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Dietary Screener Questionnaire responses measuring food consumption frequency
Measured: Baseline
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Dietary Screener Questionnaire responses measuring food consumption frequency
Measured: Week 12
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
Measured: Baseline
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
Measured: Week 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
Measured: Baseline
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
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2022
- Study start1 Dec 2021
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (50)Papers the sponsor has linked to this study.
- Other trials for Physical DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rebecca E Lee, PhD, Principal investigator, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05279989
- Sponsor's protocol ID
- STUDY00014499
- Status last verified
- Feb 2023
- First submitted
- 15 Feb 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erickson W, Lee C, von Schrader S. 2017 disability status report: United states. In: Ithaca, NY: Cornell University Yang-Tan Institute on Employment and Disability (YTI); 2019
Kraus L, Lauer E, Coleman R, Houtenville A. 2017 disability statistics annual report. Durham, NH: University of New Hampshire; 2018.
Brault M. Americans with disabilities: 2005. In. Current Populations Reports. Washington, DC: US Census Bureau; 2008:70-117.
Institute of Medicine (US) Committee on Disability in America; Field MJ, Jette AM, editors. The Future of Disability in America. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11434/
PubMed 20669428UN World Health Organization (WHO). World report on disability : Summary, 2011, who/nmh/vip/11.01. https://www.refworld.org/docid/50854a322.html. Published 2011. Accessed Feburary 1, 2021.
World Health Organization. International statistical classification of diseases and related health problems (icd-10). 10th ed. Geneva, Switzerland: World Health Organization; 1992.
World Health Organization. Health topics: Disability. https://www.who.int/health-topics/disability#tab=tab_1. Published 2021. Accessed February 1, 2021.
Karvonen-Gutierrez CA. The importance of disability as a health issue for mid-life women. Womens Midlife Health. 2015 Oct 14;1:10. doi: 10.1186/s40695-015-0011-x. eCollection 2015.
PubMed 30766697Selph SS, Skelly AC, Wasson N, Dettori JR, Brodt ED, Ensrud E, Elliot D, Dissinger KM, Hart E, Kantner S, Graham E, Junge M, Dana T, McDonagh M. Physical Activity and the Health of Wheelchair Users: A Systematic Review in Multiple Sclerosis, Cerebral Palsy, and Spinal Cord Injury [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Oct. Report No.: 21(22)-EHC017. Available from http://www.ncbi.nlm.nih.gov/books/NBK574873/
PubMed 34723448Nosek MA, Hughes RB, Robinson-Whelen S, Taylor HB, Howland CA. Physical activity and nutritional behaviors of women with physical disabilities: physical, psychological, social, and environmental influences. Womens Health Issues. 2006 Nov-Dec;16(6):323-33. doi: 10.1016/j.whi.2006.08.002.
PubMed 17188215Rosenberg DE, Bombardier CH, Hoffman JM, Belza B. Physical activity among persons aging with mobility disabilities: shaping a research agenda. J Aging Res. 2011;2011:708510. doi: 10.4061/2011/708510. Epub 2011 Jun 26.
PubMed 21748010Froehlich-Grobe K, Lee J, Washburn RA. Disparities in obesity and related conditions among Americans with disabilities. Am J Prev Med. 2013 Jul;45(1):83-90. doi: 10.1016/j.amepre.2013.02.021.
PubMed 23790992Harris RB, Zhou J, Youngblood BD, Rybkin II, Smagin GN, Ryan DH. Effect of repeated stress on body weight and body composition of rats fed low- and high-fat diets. Am J Physiol. 1998 Dec;275(6):R1928-38. doi: 10.1152/ajpregu.1998.275.6.R1928.
PubMed 9843882Hughes RB, Nosek MA, Robinson-Whelen S. Correlates of depression in rural women with physical disabilities. J Obstet Gynecol Neonatal Nurs. 2007 Jan-Feb;36(1):105-114. doi: 10.1111/j.1552-6909.2006.00122.x.
PubMed 17238955Hughes RB, Robinson-Whelen S, Taylor HB, Hall JW. Stress self-management: an intervention for women with physical disabilities. Womens Health Issues. 2006 Nov-Dec;16(6):389-99. doi: 10.1016/j.whi.2006.08.003.
PubMed 17188222
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Healthy Weight and Stress Management Study
- ClinicalTrials.gov ID
- NCT05279989
- Acronym / sponsor ID
- STUDY00014499
- Conditions
- Physical Disability, Obesity, Muscle Weakness, Anxiety, Depression
- Keywords
- Mobility impairment, Tai Chi, Stress Management, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 15 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Seated Tai Chi Qigong | Experimental | Other: Seated Tai Chi QigongParticipants 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. |
| Control | Placebo comparator | Other: Health Information VideosThe 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. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Community dwelling.
- Female.
- Age 35-64.
- Waist circumference >83 cm (~35 inches).
- Have a self-reported mobility impairment due to a chronic (>1 year).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seated Tai Chi QigongParticipants will receive seated Tai Chi Qigong videos. | Other | Seated Tai Chi Qigong |
| Health Information VideosParticipants will receive videos of health information. | Other | Control |
Primary outcome
Waist Circumference assessed by measuring tape
Time frame: Baseline
Waist Circumference assessed by measuring tape
Waist Circumference assessed by measuring tape
Time frame: Week 4
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape
Time frame: Week 8
Waist Circumference (cm) assessed by measuring tape
Waist Circumference measured by measuring tape
Time frame: Week 12
Waist Circumference (cm) assessed by measuring tape
Handgrip strength measured by isokinetic handgrip dynamometry
Time frame: Baseline
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Time frame: Week 4
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Time frame: Week 8
Weight (kg) resisted measured by handgrip dynamometer
Handgrip strength measured by isokinetic handgrip dynamometry
Time frame: Week 12
Weight (kg) resisted measured by handgrip dynamometer
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Time frame: Baseline
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Depressive Symptoms assessed by Center for Epidemiologic Studies Depression Scale
Time frame: Week 12
Center for Epidemiologic Studies Depression Score ranging from 0-3, with lower scores indicating a more desirable outcome.
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Time frame: Baseline
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome.
Anxiety assessed by Generalized Anxiety Disorder 7-item Scale
Time frame: Week 12
Generalized Anxiety Disorder 7-item Scale Score ranging from 0-21, with lower scores indicating a more desirable outcome
12 secondary outcomes
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Time frame: Baseline
Emotional Eating assessed by Mindful Eating Questionnaire - 5 Factor
Time frame: Week 12
Sleep Quality assessed by the Pittsburgh Sleep Quality Index
Time frame: Baseline
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time frame: Week 4
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time frame: Week 8
Sleep Quality assessed by Pittsburgh Sleep Quality Index
Time frame: Week 12
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Time frame: Baseline
Food Consumption Frequency assessed by the Dietary Screener Questionnaire
Time frame: Week 12
Physical Functioning assessed by the Short-Form Health Survey
Time frame: Baseline
Physical Functioning assessed by The Short-Form Health Survey
Time frame: Week 12
Well-Being assessed by the Short-Form Health Survey
Time frame: Baseline
Well-Being assessed by the Short-Form Health Survey
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- BackgroundErickson W, Lee C, von Schrader S. 2017 disability status report: United states. In: Ithaca, NY: Cornell University Yang-Tan Institute on Employment and Disability (YTI); 2019
- BackgroundKraus L, Lauer E, Coleman R, Houtenville A. 2017 disability statistics annual report. Durham, NH: University of New Hampshire; 2018.
- BackgroundBrault M. Americans with disabilities: 2005. In. Current Populations Reports. Washington, DC: US Census Bureau; 2008:70-117.
- Background: PubMed 20669428Institute of Medicine (US) Committee on Disability in America; Field MJ, Jette AM, editors. The Future of Disability in America. Washington (DC): National Academies Press (US); 2007. Available from http://www.ncbi.nlm.nih.gov/books/NBK11434/
- BackgroundUN World Health Organization (WHO). World report on disability : Summary, 2011, who/nmh/vip/11.01. https://www.refworld.org/docid/50854a322.html. Published 2011. Accessed Feburary 1, 2021.
- BackgroundWorld Health Organization. International statistical classification of diseases and related health problems (icd-10). 10th ed. Geneva, Switzerland: World Health Organization; 1992.
- BackgroundWorld Health Organization. Health topics: Disability. https://www.who.int/health-topics/disability#tab=tab_1. Published 2021. Accessed February 1, 2021.
- Background: PubMed 30766697Karvonen-Gutierrez CA. The importance of disability as a health issue for mid-life women. Womens Midlife Health. 2015 Oct 14;1:10. doi: 10.1186/s40695-015-0011-x. eCollection 2015.
- Background: PubMed 34723448Selph SS, Skelly AC, Wasson N, Dettori JR, Brodt ED, Ensrud E, Elliot D, Dissinger KM, Hart E, Kantner S, Graham E, Junge M, Dana T, McDonagh M. Physical Activity and the Health of Wheelchair Users: A Systematic Review in Multiple Sclerosis, Cerebral Palsy, and Spinal Cord Injury [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2021 Oct. Report No.: 21(22)-EHC017. Available from http://www.ncbi.nlm.nih.gov/books/NBK574873/
- Background: PubMed 17188215Nosek MA, Hughes RB, Robinson-Whelen S, Taylor HB, Howland CA. Physical activity and nutritional behaviors of women with physical disabilities: physical, psychological, social, and environmental influences. Womens Health Issues. 2006 Nov-Dec;16(6):323-33. doi: 10.1016/j.whi.2006.08.002.
- Background: PubMed 21748010Rosenberg DE, Bombardier CH, Hoffman JM, Belza B. Physical activity among persons aging with mobility disabilities: shaping a research agenda. J Aging Res. 2011;2011:708510. doi: 10.4061/2011/708510. Epub 2011 Jun 26.
- Background: PubMed 23790992Froehlich-Grobe K, Lee J, Washburn RA. Disparities in obesity and related conditions among Americans with disabilities. Am J Prev Med. 2013 Jul;45(1):83-90. doi: 10.1016/j.amepre.2013.02.021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca E Lee, PhD principal investigator
Arizona State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seated Tai Chi Qigong and Health Information Videos in people with Physical Disability and Obesity, run by Arizona State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Waist Circumference assessed by measuring tape (time frame: Baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05279989, which also lists 50 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.