Healthy AgingNCT05006261
A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
A study testing Tele-Tai Chi in people with Healthy Aging, run by Spaulding Rehabilitation Hospital at 1 site in United States.
Trial summary
This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Tele-Tai Chi
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2021to 18 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 60 and 85 years old
- TC naïve (i.e., never practiced TC)
- Self-reported ability to walk continuously for 15 minutes without an assistive device
- Working email address
- Prior experience with and current access to a computer, smart phone or tablet device
Who cannot join
- Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)
- Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study
- Active cancer
- Significant musculoskeletal conditions requiring chronic use of pain medication
- Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score < 18)
Trial locations and contacts
1 site in 1 country.
United States1 site
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02129
About this study
This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.
Read the detailed description
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency.
Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).
Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.
- Conditions
- Healthy Aging
- Being tested
- Tele-Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Tai ChiDevice
12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Tai Chi | Experimental | Tele-Tai Chi intervention Receives: Device: Tele-Tai Chi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protocol Adherence
The percentage of Tai Chi home practice sessions completed by participants.
Measured: Post-intervention (approximately 12 weeks)
Retention
The percentage of participants who complete the study.
Measured: Through study completion, approximately 12 weeks from the beginning of the study
System Usability Scale
The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.
Measured: Post-intervention (approximately 12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start29 Sep 2021
- Primary completion18 Oct 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AgingStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Bonato, Spaulding Rehabilitation Hospital
- Investigators
- Paolo Bonato, PhD, Principal investigator, Spaulding Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006261
- Sponsor's protocol ID
- 2020P002974
- Status last verified
- Nov 2024
- First submitted
- 27 Jul 2021
- Last updated
- 10 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
- ClinicalTrials.gov ID
- NCT05006261
- Acronym / sponsor ID
- 2020P002974
- Conditions
- Healthy Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Spaulding Rehabilitation HospitalUniversity, hospital or other
- Study start
- 29 Sep 2021 (actual)
- Primary completion
- 18 Oct 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.
Detailed description
The overall goal of the study is to test the delivery of a novel Tele-Tai Chi (TC) intervention in a single-arm feasibility study for community-dwelling TC-naïve older adults. The investigators will assess feasibility and acceptability of the Tele-TC intervention and its specific components through both qualitative and quantitative feedback, as well as the systematic tracking of adherence data to inform future trials and potential clinical use of the Tele-TC system. The investigators will also explore changes in outcome measures including physical activity, self-efficacy, quality of life, and gait, and evaluate changes in TC proficiency.
Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).
Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 live sessions with TC instructors two or more times during the study period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-Tai Chi | Experimental | Device: Tele-Tai ChiTele-Tai Chi intervention |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 60 and 85 years old
- TC naïve (i.e., never practiced TC)
- Self-reported ability to walk continuously for 15 minutes without an assistive device
- Working email address
- Prior experience with and current access to a computer, smart phone or tablet device
Key exclusion criteria (5 listed)
- Chronic neuromuscular conditions (e.g. Parkinson's disease, multiple sclerosis, stroke)
- Acute medical conditions requiring hospitalization within the past 6 months or that could interfere with the ability of prospective volunteers to safely participate in the study
- Active cancer
- Significant musculoskeletal conditions requiring chronic use of pain medication
- Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score < 18)
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 |
|---|---|---|
| Tele-Tai Chi12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions. | Device | Tele-Tai Chi |
Primary outcome
Protocol Adherence
Time frame: Post-intervention (approximately 12 weeks)
The percentage of Tai Chi home practice sessions completed by participants.
Retention
Time frame: Through study completion, approximately 12 weeks from the beginning of the study
The percentage of participants who complete the study.
System Usability Scale
Time frame: Post-intervention (approximately 12 weeks)
The scale is based on a 10-item questionnaire with five response options (from Strongly agree to Strongly disagree) in which participants rate the usability of the system. The scale ranges from 0 to 100, with higher scores indicating greater usability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paolo Bonato, PhD principal investigator
Spaulding Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Tai Chi in people with Healthy Aging, run by Spaulding Rehabilitation Hospital 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 5 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 10 Dec 2024. 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. 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?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Protocol Adherence (time frame: Post-intervention (approximately 12 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.