Trial Outcomes & Findings for A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults (NCT NCT05209464)

NCT ID: NCT05209464

Last Updated: 2024-08-28

Results Overview

The percentage of Tele-Tai-Chi practice sessions completed by participants.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

8 participants

Primary outcome timeframe

Percentage at post-intervention (after 12 weeks)

Results posted on

2024-08-28

Participant Flow

Participant milestones

Participant milestones
Measure
Tele-Tai Chi
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Overall Study
STARTED
8
Overall Study
COMPLETED
7
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Tele-Tai Chi
n=8 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Age, Categorical
<=18 years
0 Participants
n=99 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
n=99 Participants
Age, Categorical
>=65 years
6 Participants
n=99 Participants
Age, Continuous
70 years
n=99 Participants
Sex: Female, Male
Female
6 Participants
n=99 Participants
Sex: Female, Male
Male
2 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
8 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=99 Participants
Race (NIH/OMB)
White
7 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
8 participants
n=99 Participants

PRIMARY outcome

Timeframe: Percentage at post-intervention (after 12 weeks)

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

The percentage of Tele-Tai-Chi practice sessions completed by participants.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Protocol Adherence
78.6 percentage of sessions completed
Standard Deviation 45.1

PRIMARY outcome

Timeframe: At study completion, 12 weeks from the beginning of the study

Population: Please note that 1 participant who was found not eligible after consent.

The percentage of participants who complete the study.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=8 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Retention of Study Participants
87.5 percentage of subjects retained

PRIMARY outcome

Timeframe: At post-intervention (after 12 weeks)

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

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
System Usability Scale
87.9 score on a scale
Standard Deviation 11.4

OTHER_PRE_SPECIFIED outcome

Timeframe: At post-intervention (after 12 weeks)

Population: 1 of the 8 participants was found ineligible after providing consent. 1 additional participant did not provide feedback about the ease of use of the Tai Chi platform. The remaining 6 subjects provided positive feedback.

Qualitative interview about ease of use of the Tele-Tai Chi platform.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)
100 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

This is 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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Activities-specific Balance Confidence (ABC) Scores
0.8 score on a scale
Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Sleep Disturbance
-1.2 score on a scale
Standard Deviation 2.5
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Pain Intensity
0.2 score on a scale
Standard Deviation 2.2
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Ability to Participate in Social Roles/Activities
-0.7 score on a scale
Standard Deviation 0.5
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Anxiety/Fear
-0.7 score on a scale
Standard Deviation 0.8
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Depression/Sadness
-0.2 score on a scale
Standard Deviation 1.3
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Fatigue
-1.8 score on a scale
Standard Deviation 1.9
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Pain Interference
0.7 score on a scale
Standard Deviation 3.4
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
Physical Function
-0.2 score on a scale
Standard Deviation 1.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline to post-intervention (at 12 weeks)

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

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Physical Activity Scale for the Elderly (PASE)
-10 score on a scale
Standard Deviation 43.8

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

The 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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Trail Making Test A/B Scores
Part A
-14.8 seconds
Standard Deviation 22.6
Trail Making Test A/B Scores
Part B
-39 seconds
Standard Deviation 44.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Self-Efficacy Exercise (SEE) Questionnaire
-2 score on a scale
Standard Deviation 4.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

Population: 1 of the 8 participants was found ineligible after providing consent. 1 additional participant did not completed both baseline and post-intervention assessments. Data analysis was limited the remaining 6 participants completed both baseline and post-intervention assessments.

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Change in Tai Chi Proficiency Score
6.1 score on a scale
Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

Test routinely used in clinical practice 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

Outcome measures
Measure
Tele-Tai Chi
n=5 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Timed-Up-and-Go
-1.69 seconds
Standard Deviation 0.74

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

Test routinely used in clinical practice to determine fall risk and ambulation status. 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

Outcome measures
Measure
Tele-Tai Chi
n=5 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Timed-Up-and-Go Dual Task
-0.76 seconds
Standard Deviation 6.45

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

Population: Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. Only the trial with the longest time was considered for analysis.

Measured with a motion capture system. 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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Single Leg Stance
Right Leg
5.68 seconds
Standard Deviation 4.43
Single Leg Stance
Left Leg
5.13 seconds
Standard Deviation 11.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

Measure of fall risks. 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.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=5 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Sit-to-Stand Performance
1 repetitions
Standard Deviation 2

OTHER_PRE_SPECIFIED outcome

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

Population: Data analysis was limited only to subjects who participated 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 (i.e., standing on both legs with feet shoulder-width apart and standing on both legs with feet close to each other).

Participants are instructed to perform two tasks: 1) stand on both legs with feet shoulder-width apart for approximately 20 seconds, and 2) stand on both legs with feet close to each other again for approximately 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 8 variables.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Postural Sway and Balance
Feet Apart AP - Baseline
60 millimeters per second squared
Standard Deviation 0.7
Postural Sway and Balance
Feet Apart AP - Post-Intervention
60.4 millimeters per second squared
Standard Deviation 0.7
Postural Sway and Balance
Feet Apart ML - Baseline
60.4 millimeters per second squared
Standard Deviation 0.7
Postural Sway and Balance
Feet Apart ML - Post-intervention
60.4 millimeters per second squared
Standard Deviation 0.8
Postural Sway and Balance
Feet Together AP - Baseline
59.8 millimeters per second squared
Standard Deviation 0.6
Postural Sway and Balance
Feet Together AP - Post-Intervention
59.7 millimeters per second squared
Standard Deviation 0.5
Postural Sway and Balance
Feet Together ML - Baseline
59.7 millimeters per second squared
Standard Deviation 0.7
Postural Sway and Balance
Feet Together ML - Post-intervention
59.8 millimeters per second squared
Standard Deviation 0.6

OTHER_PRE_SPECIFIED outcome

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

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

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

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Normalized-to-height Stride Length
Normalized Stride Length - Post-intervention (unitless)
0.43 unitless
Standard Deviation 0.04
Normalized-to-height Stride Length
Normalized Stride Length - Baseline (unitless)
0.42 unitless
Standard Deviation 0.02

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

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

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Activity Level
179 steps per day
Standard Deviation 2226

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

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

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Mini-Balance Evaluation Systems Test (MiniBEST)
-3 score on a scale
Standard Deviation 3.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

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

The test examines working memory span. COWAT requires the participant to produce as many words as possible that begin with a given letter of the alphabet (F,A,S). There is 1 minute allowed for each of the three letters. The score is the sum of all acceptable words produced in the three trials.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Controlled Oral Word Association Test (COWAT) Scores
3 words
Standard Deviation 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

Population: Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. Only the length of the longest sequence successfully completed was considered.

The test assesses short-term memory by asking participants to memorize and recall in correct serial order a number of digits (i.e., numerals from 0 to 9). The test start asking participants to memorize fewer digits and then the number of digits is increased. The number sequences get progressively more difficult. Scores are based on the number of sequences correctly recalled (i.e., until the participant consecutively fails two trials of the same digit span length).

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=5 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Change in Digit Span Test Score
0.5 sequences
Standard Deviation 0.58

OTHER_PRE_SPECIFIED outcome

Timeframe: Changes from baseline at 12 weeks (post-intervention)

Population: Data analysis was limited only to subjects who participated in the intervention and completed both baseline and post-intervention assessments. The average of three trials was considered for the analysis.

Investigators measure the grip strength of both upper limbs using a hand grip dynamometer. They repeat the measure three times (per side) for a total of six trials. The average value of the six trials is derived. Measures are gather at baseline and post-intervention. The difference in mean values (post-intervention minus baseline) is reported.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Change in Grip Strength
2.4 kilograms
Standard Deviation 2.1

OTHER_PRE_SPECIFIED outcome

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

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

Study participants undergo an instrumented gait evaluation. Stride time is measured as the time from foot contact to the next foot contact of the same leg. Stride time variability is defined as the standard deviation of the stride time values estimated for a session.

Outcome measures

Outcome measures
Measure
Tele-Tai Chi
n=6 Participants
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Stride Time Variability
Stride Time Variability - Baseline
7.86 milliseconds
Standard Deviation 9.46
Stride Time Variability
Stride Time Variability - Post-intervention
3.83 milliseconds
Standard Deviation 3.54

Adverse Events

Tele-Tai Chi

Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Tele-Tai Chi
n=7 participants at risk
Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application. Tele-Tai Chi: Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via an application installed on a tablet. The intervention emphasizes essential TC movements that are easily comprehensible and can be performed repetitively in a flowing manner. The protocol includes up to six core TC movements based on the traditional Cheng Man-Ch'ing's Yang-style short form. Additionally, a set of traditional TC warm-up exercises that focus on loosening the physical body, incorporating mindfulness and imagery into movement, promoting overall relaxation, and coordinating breathing awareness are included. Chairs are used in the protocol for a subset of seated warm-up exercises, as well as for stability and rest as needed. Participants will be asked to practice the protocol (45-60 min) at home for at least 3 days a week for 12 weeks. The TC program will also include 2 or more live instructional sessions via Zoom with a TC instructor.
Musculoskeletal and connective tissue disorders
Delayed onset muscle pain
28.6%
2/7 • Number of events 2 • Adverse events were collected throughout the intervention period (approx. 12 weeks).
Infections and infestations
Flu-like illness
28.6%
2/7 • Number of events 2 • Adverse events were collected throughout the intervention period (approx. 12 weeks).
Musculoskeletal and connective tissue disorders
Low back pain
28.6%
2/7 • Number of events 2 • Adverse events were collected throughout the intervention period (approx. 12 weeks).
Gastrointestinal disorders
Cholecystitis
14.3%
1/7 • Number of events 1 • Adverse events were collected throughout the intervention period (approx. 12 weeks).
Injury, poisoning and procedural complications
Fall
28.6%
2/7 • Number of events 2 • Adverse events were collected throughout the intervention period (approx. 12 weeks).

Additional Information

Paolo Bonato, PhD

Spaulding Rehabilitation Hospital

Phone: 617-952-6319

Results disclosure agreements

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