Trial Outcomes & Findings for A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II (NCT NCT05006261)

NCT ID: NCT05006261

Last Updated: 2024-12-10

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Post-intervention (approximately 12 weeks)
• Results posted on: 2024-12-10

Participant Flow

Participant milestones

Measure	Tele-Tai Chi Tele-Tai Chi intervention Tele-Tai Chi: 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.
Overall Study STARTED	27
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tele-Tai Chi n=27 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants
Age, Continuous	70 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants

PRIMARY outcome

Timeframe: Post-intervention (approximately 12 weeks)

Population: All dataset was considered

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

Outcome measures

Measure	Tele-Tai Chi n=26 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Protocol Adherence	76.81 percentage of session completed Standard Deviation 37.32

PRIMARY outcome

Timeframe: Through study completion, approximately 12 weeks from the beginning of the study

The percentage of participants who complete the study.

Outcome measures

Measure	Tele-Tai Chi n=26 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Retention	100 percentage of subject retained

PRIMARY outcome

Timeframe: Post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
System Usability Scale	87.18 score on a scale Standard Deviation 13.31

OTHER_PRE_SPECIFIED outcome

Timeframe: Post-intervention (approximately 12 weeks)

Population: All dataset analyzed.

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.

Outcome measures

Measure	Tele-Tai Chi n=26 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)	85 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete and extreme outliers were eliminated. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores	1.48 score on a scale Standard Deviation 33.59

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete.

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 anxiety, depression, fatigue, sleep disturbance, pain interference, and pain intensity a low score is indicative of positive outcome.

Outcome measures

Measure	Tele-Tai Chi n=19 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Fatigue	-0.78 score on a scale Standard Deviation 2.19
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Pain Interference	-0.42 score on a scale Standard Deviation 1.49
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Physical Function	0.21 score on a scale Standard Deviation 0.76
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Sleep Disturbance	-0.57 score on a scale Standard Deviation 2.08
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Pain Intensity	-0.26 score on a scale Standard Deviation 1.11
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Ability to Participate in Social Roles/Activities	-0.31 score on a scale Standard Deviation 2.31
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Anxiety/Fear	0.10 score on a scale Standard Deviation 1.68
Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores Depression and Sadness	0.26 score on a scale Standard Deviation 1.33

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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 for 4.5 hours per day.

Outcome measures

Measure	Tele-Tai Chi n=19 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Physical Activity Scale for the Elderly (PASE)	27.73 score on a scale Standard Deviation 71.16

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis. For the analysis of Part A only 24 patients were considered.

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.

Outcome measures

Measure	Tele-Tai Chi n=25 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Trail Making Test A/B Scores Part A	-0.24 seconds Standard Deviation 7.81
Changes From Baseline in Trail Making Test A/B Scores Part B	-3.37 seconds Standard Deviation 35.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire	-12.6 score on a scale Standard Deviation 19.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Change from Baseline at Post-Intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=22 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Tai Chi Proficiency Scores	6.42 score on a scale Standard Deviation 2.86

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Timed-Up-and-Go	0.00 seconds Standard Deviation 1.20

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

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.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Timed-Up-and-Go Dual Task	0.08 seconds Standard Deviation 1.78

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

Balance on each leg (two trials): The participant is asked to stand on one leg for as long as they can up to a maximum of 30 seconds.

Outcome measures

Measure	Tele-Tai Chi n=24 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Single Leg Stance Left Leg	1.75 seconds Standard Deviation 7.67
Changes From Baseline in Single Leg Stance Right Leg	0.73 seconds Standard Deviation 10.04

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset is incomplete. Participants with missing data were excluded from the analysis.

Sit-to-Stand Test: The participant is asked to stand up from a chair while keeping their arms crossed across their chest and repeat the task as many times as possible during a period of 30 seconds. A higher count of completed repetitions is considered indicative of improved performance.

Outcome measures

Measure	Tele-Tai Chi n=25 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Sit-to-Stand Performance	0.04 score on a scale Standard Deviation 1.56

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.

Balance on both legs with feet shoulder-width apart: The participant is asked to stand with feet shoulder-width apart for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for each condition for a total of 4 variables.

Outcome measures

Measure	Tele-Tai Chi n=21 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart AP-Baseline	60.03 millimeters per second squared Standard Deviation 1.30
Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart AP-Post Intervention	60.73 millimeters per second squared Standard Deviation 0.82
Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart ML-Baseline	60.05 millimeters per second squared Standard Deviation 1.36
Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart ML-Post Intervention	60.48 millimeters per second squared Standard Deviation 0.92

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: Data analysis was limited only to subjects who completed in the intervention and completed both baseline and post-intervention assessments. The root mean square (RMS) value of the acceleration in the antero-posterior (AP) and medio-lateral (ML) directions at the waist sensor was calculated for middle 15 seconds of each experiment.

Balance on both legs with feet close to each other: The participant is asked to stand with feet as close as possible (without contact between the feet) for about 20 seconds. A sensor positioned at the waist is used to track the displacement of the center of mass during the 20 second data collection (for each task). The root mean square (RMS) value of the acceleration data collected using the sensor positioned at the waist is estimated in the antero-posterior (AP) and medio-lateral (ML) directions for the middle 15 seconds of each experiment. Data is gathered at baseline and post-intervention and derived for a total of 4 variables.

Outcome measures

Measure	Tele-Tai Chi n=20 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Postural Sway and Balance on Both Legs With Feet Close to Each Other AP - Baseline	60.14 millimeters per second squared Standard Deviation 1.35
Postural Sway and Balance on Both Legs With Feet Close to Each Other AP - Post Intervention	60.57 millimeters per second squared Standard Deviation 0.57
Postural Sway and Balance on Both Legs With Feet Close to Each Other ML - Baseline	59.93 millimeters per second squared Standard Deviation 1.18
Postural Sway and Balance on Both Legs With Feet Close to Each Other ML - Post Intervention	60.35 millimeters per second squared Standard Deviation 0.65

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset is incomplete. Participants with missing data were excluded from the analysis.

Study participants will undergo an instrumented gait evaluation. Stride length will be defined as the distance from ipsilateral foot contact to the next ipsilateral foot contact during gait. Normalized-to-height stride length will be derived by computing the stride length using the gait evaluation equipment and dividing such value by the height of the study participant.

Outcome measures

Measure	Tele-Tai Chi n=22 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Normalized-to-height Stride Length Normalized Stride Length - Baseline (unitless)	0.41 unitless Standard Deviation 0.04
Normalized-to-height Stride Length Normalized Stride Length - Post Intervention (unitless)	0.41 unitless Standard Deviation 0.06

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and post-intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

Study participants will undergo an instrumented gait evaluation. Stride time will be defined as the time interval between two consecutive foot contacts of the same limb. Stride time variability will be computed as the standard deviation of the stride time estimates derived using the gait evaluation equipment.

Outcome measures

Measure	Tele-Tai Chi n=22 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Stride Time Variability Stride Time Variability - Baseline	10.32 milliseconds Standard Deviation 8.79
Stride Time Variability Stride Time Variability - Discharge	12.27 milliseconds Standard Deviation 14.70

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of intervention (approximately 12 weeks)

Population: The dataset was incomplete. Participants with missing data were excluded from the analysis.

Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.

Outcome measures

Measure	Tele-Tai Chi n=9 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Activity Level	1044 steps per day Standard Deviation 2526

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and end of intervention (approximately 12 weeks)

Population: Data analysis was limited only to subjects who completed both baseline and post-intervention assessments in the laboratory.

MiniBEST Test: Test to assess dynamic balance. It is a 14-item test scored using a three-level ordinal scale. This test will be performed only in individuals who are willing to be tested in the laboratory (as opposed to via a remote visit). The minimum score is 0. The maximum score is 28. Positive changes (i.e., higher scores post-intervention) would represent a positive outcome.

Outcome measures

Measure	Tele-Tai Chi n=8 Participants Tele-Tai Chi intervention Tele-Tai Chi: 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.
Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)	0.5 score on a scale Standard Deviation 1.5

Adverse Events

Tele-Tai Chi

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tele-Tai Chi n=26 participants at risk Tele-Tai Chi intervention Tele-Tai Chi: 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.
Musculoskeletal and connective tissue disorders Back Pain	11.5% 3/26 • Number of events 6 • 12 weeks
Respiratory, thoracic and mediastinal disorders Flu-like illness	19.2% 5/26 • Number of events 5 • 12 weeks
Injury, poisoning and procedural complications Fall	11.5% 3/26 • Number of events 4 • 12 weeks
General disorders Headache	3.8% 1/26 • Number of events 1 • 12 weeks
Musculoskeletal and connective tissue disorders Knee Pain	7.7% 2/26 • Number of events 2 • 12 weeks
Musculoskeletal and connective tissue disorders Delayed Onset Muscle Soreness	15.4% 4/26 • Number of events 6 • 12 weeks
Skin and subcutaneous tissue disorders Skin Irritation	3.8% 1/26 • Number of events 1 • 12 weeks
General disorders Dizziness	11.5% 3/26 • Number of events 3 • 12 weeks

Additional Information

Paolo Bonato, PhD

Spaulding Rehabilitation Hospital

Phone: 617-952-6319

Email: pbonato@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place