NCT05006261

A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II

Completed NA Results posted Last updated 10 December 2024

What this trial tests

NA trial testing Tele-Tai Chi in Healthy Aging in 30 participants. Completed in 18 October 2023.

Timeline

29 September 2021

Primary endpoint
18 October 2023

18 October 2023

Quick facts

Lead sponsor	Spaulding Rehabilitation Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	30
Start date	29 September 2021
Primary completion	18 October 2023
Estimated completion	18 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Tele-Tai Chi

Conditions studied

• Healthy Aging — all drugs for Healthy Aging →

Sponsor

Spaulding Rehabilitation Hospital

Who can join

Adults 60 to 85, any sex, with Healthy Aging. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Protocol Adherence Primary · Post-intervention (approximately 12 weeks)

The percentage of Tai Chi home practice sessions completed by participants.

Group	Value	95% CI
Tele-Tai Chi	76.81	± 37.32

Retention Primary · Through study completion, approximately 12 weeks from the beginning of the study

The percentage of participants who complete the study.

Group	Value	95% CI
Tele-Tai Chi	100

System Usability Scale Primary · 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.

Group	Value	95% CI
Tele-Tai Chi	87.18	± 13.31

Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview) Secondary · Post-intervention (approximately 12 weeks)

Qualitative interview about ease of use of the Tele-Tai Chi platform. The outcome will be the percentage of participants who provide positive feedback regarding the platform's ease of use.

Group	Value	95% CI
Tele-Tai Chi	85

Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores Secondary · Baseline and post-intervention (approximately 12 weeks)

Activities-specific Balance Confidence (ABC): 16-item self-report measure in which participants rate their balance confidence to perform motor activities. The minimum score is 0. The maximum score is 100. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Group	Value	95% CI
Tele-Tai Chi	1.48	± 33.59

Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Secondary · Baseline and post-intervention (approximately 12 weeks)

The PROMIS 29 instrument is a 29-item questionnaire assessing each of the following domains: anxiety, depression, fatigue, physical function, pain interference, pain intensity, sleep disturbance, and ability to participate in social roles and activities. The minimum score is 4 per domain, except for pain intensity for which the minimum score is 0. The maximum score per domain is 20, except for pain intensity for which the maximum score is 10. For the physical function and the ability to participate in social roles and activities domains a high score is indicative of positive outcome. For the a

Ability to Participate in Social Roles/Activities

Group	Value	95% CI
Tele-Tai Chi	-0.31	± 2.31

Anxiety/Fear

Group	Value	95% CI
Tele-Tai Chi	0.10	± 1.68

Depression and Sadness

Group	Value	95% CI
Tele-Tai Chi	0.26	± 1.33

Fatigue

Group	Value	95% CI
Tele-Tai Chi	-0.78	± 2.19

Pain Interference

Group	Value	95% CI
Tele-Tai Chi	-0.42	± 1.49

Physical Function

Group	Value	95% CI
Tele-Tai Chi	0.21	± 0.76

Sleep Disturbance

Group	Value	95% CI
Tele-Tai Chi	-0.57	± 2.08

Pain Intensity

Group	Value	95% CI
Tele-Tai Chi	-0.26	± 1.11

Changes From Baseline in Physical Activity Scale for the Elderly (PASE) Secondary · Baseline and post-intervention (approximately 12 weeks)

Physical Activity Scale for the Elderly (PASE): self-reported level of physical activity in individuals aged 65 years or older during the previous 7 days. The score accounts for the type of activities performed and the time of performance of each activity. The minimum score is 0. The scale has theoretical maximum value of 864, if subjects spent 24 hours per day over 7 days engaged in vigorous activities. However, as this is not possible, a maximum value of 400 is typically considered as that would correspond to being engage in vigorous activities for 8 hours per day + more moderate activities

Group	Value	95% CI
Tele-Tai Chi	27.73	± 71.16

Changes From Baseline in Trail Making Test A/B Scores Secondary · Baseline and post-intervention (approximately 12 weeks)

Trail Making Test (TMT): Test to assess executive cognitive function. It has two parts: TMT A (number sequence only) considers visual search, and TMT B (alternating numbers and letters) evaluates executive control. The participant is asked to draw a line between 24 circles randomly arranged on a page that have to be linked in consecutive order. The TMT is scored by how long it takes to complete the test.

Part A

Group	Value	95% CI
Tele-Tai Chi	-0.24	± 7.81

Part B

Group	Value	95% CI
Tele-Tai Chi	-3.37	± 35.06

Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire Secondary · Baseline and post-intervention (approximately 12 weeks)

Exercise Self-efficacy Questionnaire (SEE): 9-item questionnaire that focuses on the self-efficacy expectations for exercise for older adults. The minimum score is 0. The maximum score is 90. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Group	Value	95% CI
Tele-Tai Chi	-12.6	± 19.92

Changes From Baseline in Tai Chi Proficiency Scores Secondary · Change from Baseline at Post-Intervention (approximately 12 weeks)

Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the six Tai Chi movements performed by participants. The minimum score is 6. The maximum score is 30 per Tai Chi exercise. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome. The change in Tai Chi proficiency score ranges from -24 to +24. A change equal to 0 represents no change in proficiency.

Group	Value	95% CI
Tele-Tai Chi	6.42	± 2.86

Changes From Baseline in Timed-Up-and-Go Secondary · Baseline and post-intervention (approximately 12 weeks)

Timed-Up-and-Go: Test to determine fall risk. The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair.

Group	Value	95% CI
Tele-Tai Chi	0.00	± 1.20

Changes From Baseline in Timed-Up-and-Go Dual Task Secondary · Baseline and post-intervention (approximately 12 weeks)

Dual task Timed-Up-and-Go test: The participant is asked to stand up from a chair, walk 3 meters, turns 180°, walk 3 meters back, and sits back down with back resting against the chair while counting backwards by three.

Group	Value	95% CI
Tele-Tai Chi	0.08	± 1.78

Adverse events — posted to ClinicalTrials.gov

Time frame: 12 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tele-Tai Chi

Serious: 0/26 (0%)

Deaths: 0/26

Other adverse events (8 terms — click to expand)

Reaction	System	Tele-Tai Chi
Flu-like illness	Respiratory, thoracic and mediastinal disorders	—
Delayed Onset Muscle Soreness	Musculoskeletal and connective tissue disorders	—
Back Pain	Musculoskeletal and connective tissue disorders	—
Fall	Injury, poisoning and procedural complications	—
Dizziness	General disorders	—
Knee Pain	Musculoskeletal and connective tissue disorders	—
Headache	General disorders	—
Skin Irritation	Skin and subcutaneous tissue disorders	—

Data from ClinicalTrials.gov NCT05006261 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.