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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tele Tai Chi
8-week Tele Tai Chi intervention
Behavioral: Tele Tai Chi Intervention for Persons Aging with Long-Term Mobility Disabilities
• 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:
  • Seated Tai Chi for Arthritis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Georgia Institute of Technology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Georgia
University of Illinois at Urbana-Champaign
National Institute on Disability, Independent Living, and Rehabilitation Research
Tai Chi for Health Institute

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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