- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04696887
TechSAge Tele Tai Chi for People Aging With Mobility Disabilities
October 16, 2023 updated by: Tracy Mitzner, Georgia Institute of Technology
This study uses videoconferencing to deliver an evidence-based exercise program, Seated Tai Chi for Arthritis, to adults aging with long-term mobility disabilities.
In the 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class.
The study will examine the effects of the Tele Tai Chi program on physical activity and social connectedness for adults aging with long-term mobility disabilities, a population likely to experience barriers to exercise participation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is part of the Rehabilitation Engineering Research Center on Technologies to Support Aging-in-Place for People with Long-Term Disabilities (RERC TechSAge).
This study uses videoconferencing to translate an evidence-based exercise program for older adults, Seated Tai Chi for Arthritis, from an in-person setting to a remote class and to a different population, adults aging with mobility disabilities.
In the 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class.
The study will examine the effects of the Tele Tai Chi program on physical activity and social connectedness (primary outcomes), as well as exercise self-efficacy, falls efficacy, depression, quality of life, and pain (secondary outcomes) for adults aging with long-term mobility disabilities, a population likely to experience barriers to in-person exercise participation.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30318
- Center for Inclusive Design and Innovation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Be between the ages of 60-80
- Self-identify as having a mobility disability, use a mobility aid (i.e., cane, crutches, wheelchair, walker, or scooter) or have serious difficulty walking or climbing stairs
- Mobility disability for at least 10 years
- Passing score on Physical Activity Readiness Questionnaire (PAR-Q) or letter from physician stating approved to participate in the intervention
- Passing score on Telephone Interview for Cognitive Status (TICS)-score 26 and above included
- Passing score of brief Technology Proficiency Screen (e.g., be able to do send and receive email)
- Have access to a webcam on computer or tablet
- Plan to have internet access for six months from screening
- Live in the US
- Be conversational in English
- Available to attend 1 hr online class 2x a week for 8 weeks
Exclusion Criteria:
- Blind or deaf
- Significant Tai Chi practice during the past 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tele Tai Chi
8-week Tele Tai Chi intervention
|
• 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity
Time Frame: Baseline, Week 1-8 of intervention, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in physical activity (mode, frequency, duration, intensity) as measured by the leisure activity dimension of the Physical Activity Scale for Persons with Physical Disabilities1, a self-report measure of physical activity (Range 0-98.67;
Higher score means greater physical activity.
Lower score means less physical activity).
Self-report completion of Tai Chi practice (Range 1-4; Higher score indicates greater frequency of practice.
Lower score indicates less frequent of practice).
|
Baseline, Week 1-8 of intervention, Post-Intervention (8 week assessment), 1 month follow-up
|
|
Social connectedness
Time Frame: Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in perception of social connectedness (loneliness), as measured by the UCLA Loneliness Scale (ULS-8)3 (Range 8-32; Higher score indicates a greater degree of loneliness.
Lower score reflects a lower degree of loneliness), Social Isolation Questionnaire4 (Social Disconnectedness Scale, Social Isolation Scale, Perceived Social Isolation scale; Range 15-67; Higher score indicates a greater degree of loneliness.
Lower score reflects a lower degree of loneliness).
|
Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Exercise Self-Efficacy
Time Frame: Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in confidence in being able to exercise, as measured by the Exercise Self-Efficacy Scale (ESES) Scale5.
A higher score indicates a greater confidence in being able to exercise.
A lower score reflects less confidence in being able to exercise.
Range (10-40).
|
Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
|
Falls Efficacy
Time Frame: Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in confidence in being able to engage in activities without falling, as measured by the Falls Efficacy Scale6 (Range 10-100; Lower score indicates greater confidence in being able to engage in activities without falling.
Higher score reflects less confidence in being able to engage in activities without falling; Total score of greater than 70 indicates that the person has a fear of falling), and a 3-item indicator of fear of falling (adapted from7-8; Range 0-5; Lower score indicates less fear of falling.
Higher score reflects greater fear of falling).
|
Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
|
Depression
Time Frame: Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in emotional distress (depression), as measured by the PROMIS Emotional Distress - Depression - Short Form9.
Higher score means greater emotional distress.
A lower score means less emotional distress.
Range (8-40).
|
Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
|
Quality of Life (QOL)
Time Frame: Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
Change in self-reported quality of life, as measured by the Kemp Quality of Life single item scale10.
Higher score means higher quality of life.
A lower score means lower quality of life.
Range (1-7).
|
Baseline, Post-Intervention (8 week assessment), 1 month follow-up
|
|
Pain Interference
Time Frame: Baseline, PPost-Intervention (8 week assessment), 1 month follow-up
|
Change in pain interference, as measured the PROMIS Pain Interference - Short Form11.
Higher score means greater pain interference.
A lower score means less pain interference.
Range (4-20).
|
Baseline, PPost-Intervention (8 week assessment), 1 month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technology Acceptance
Time Frame: Baseline, Post-Intervention (8 week assessment)
|
Change in technology acceptance, as measured the Technology Acceptance Questionnaire (modified12,13,14).
Higher score means greater technology acceptance.
A lower score means less greater technology acceptance.
Range (20-140).
|
Baseline, Post-Intervention (8 week assessment)
|
|
Physical Activity Class Satisfaction
Time Frame: Post-Intervention (8 week assessment)
|
Class Satisfaction as measured by the dimensions of mastery experience, teaching, interaction with others, improvement of health and fitness, and relaxation from the Physical Activity Class Satisfaction Questionnaire2, a self-report measure of satisfaction related to exercise classes (Range 22-176); Higher score means greater satisfaction with physical activity class.
|
Post-Intervention (8 week assessment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Washburn RA, Zhu W, McAuley E, Frogley M, Figoni SF. The physical activity scale for individuals with physical disabilities: development and evaluation. Arch Phys Med Rehabil. 2002 Feb;83(2):193-200. doi: 10.1053/apmr.2002.27467.
- 2Cunningham, G. B. (2020). Development of the Physical Activity Class Satisfaction Questionnaire (PACSQ). Measurement in Physical Education and Exercise Science, 11(3), 161-176.
- Hays RD, DiMatteo MR. A short-form measure of loneliness. J Pers Assess. 1987 Spring;51(1):69-81. doi: 10.1207/s15327752jpa5101_6.
- Kroll T, Kehn M, Ho PS, Groah S. The SCI Exercise Self-Efficacy Scale (ESES): development and psychometric properties. Int J Behav Nutr Phys Act. 2007 Aug 30;4:34. doi: 10.1186/1479-5868-4-34.
- Tinetti ME, Richman D, Powell L. Falls efficacy as a measure of fear of falling. J Gerontol. 1990 Nov;45(6):P239-43. doi: 10.1093/geronj/45.6.p239.
- Finlayson M, Peterson EW, Cho C. Pilot study of a fall risk management program for middle aged and older adults with MS. NeuroRehabilitation. 2009;25(2):107-15. doi: 10.3233/NRE-2009-0505.
- Walker JE, Howland J. Falls and fear of falling among elderly persons living in the community: occupational therapy interventions. Am J Occup Ther. 1991 Feb;45(2):119-22. doi: 10.5014/ajot.45.2.119.
- Pilkonis PA, Choi SW, Reise SP, Stover AM, Riley WT, Cella D; PROMIS Cooperative Group. Item banks for measuring emotional distress from the Patient-Reported Outcomes Measurement Information System (PROMIS(R)): depression, anxiety, and anger. Assessment. 2011 Sep;18(3):263-83. doi: 10.1177/1073191111411667. Epub 2011 Jun 21.
- Siebens HC, Tsukerman D, Adkins RH, Kahan J, Kemp B. Correlates of a Single-Item Quality-of-Life Measure in People Aging with Disabilities. Am J Phys Med Rehabil. 2015 Dec;94(12):1065-74. doi: 10.1097/PHM.0000000000000298.
- Amtmann D, Cook KF, Jensen MP, Chen WH, Choi S, Revicki D, Cella D, Rothrock N, Keefe F, Callahan L, Lai JS. Development of a PROMIS item bank to measure pain interference. Pain. 2010 Jul;150(1):173-182. doi: 10.1016/j.pain.2010.04.025.
- Davis, F. D. (1989). Perceived usefulness, perceived ease of use, and user acceptance of information technology. MIS Quarterly, 13, 319-340.
- Venkatesh, V. (2000). Determinants of perceived ease of use: Integrating perceived behavioral control, computer anxiety and enjoyment into the technology acceptance model. Information Systems Research, 11, 342-365.
- Venkatesh, V., & Bala, H. (2008). Technology Acceptance Model 3 and a research agenda on interventions. Decision Sciences, 39(2), 273-315. https://doi.org/10.1111/j.1540-5915.2008.00192.x
- Cornwell EY, Waite LJ. Measuring social isolation among older adults using multiple indicators from the NSHAP study. J Gerontol B Psychol Sci Soc Sci. 2009 Nov;64 Suppl 1(Suppl 1):i38-46. doi: 10.1093/geronb/gbp037. Epub 2009 Jun 9.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 22, 2021
Primary Completion (Actual)
October 3, 2023
Study Completion (Actual)
October 3, 2023
Study Registration Dates
First Submitted
December 15, 2020
First Submitted That Met QC Criteria
January 4, 2021
First Posted (Actual)
January 6, 2021
Study Record Updates
Last Update Posted (Actual)
October 17, 2023
Last Update Submitted That Met QC Criteria
October 16, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- H19560
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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