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

The investigators will assess feasibility and acceptability of the Tele-Tai Chi (TC) intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, cognitive function, balance, gait, and evaluate changes in TC proficiency. To achieve this, the investigators are running a single-arm study for older adults that involves a 12-week home-based Tai Chi intervention. Study participation includes four remote and/or in-person (at Spaulding Rehabilitation Hospital) visits to evaluate study participants (mobility tests and questionnaires).

Study Overview

• Status: Completed
• Conditions: Aging; Fall
• Intervention / Treatment: Device: Tele-Tai Chi

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, cognition, balance and gait, and evaluate changes in TC proficiency.

Participants will be assessed at 4 timepoints over the course of the 12-week Tele-TC intervention: at baseline, at 4 weeks, at 8 weeks, and at 12 weeks.

Study participants will be instructed to train on their own at least three times a week and to participate in one-on-one live sessions with TC instructors two or more times during the study period.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02129
      • Spaulding Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 81 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women between 60 and 85 years old
• Naïve to Tai-Chi practice (never practiced TC)
• Montreal Cognitive Assessment (MoCA) score between 17 and 13.
• 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

Exclusion Criteria:

• 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 safely participating in the study
• Active cancer
• Significant musculoskeletal conditions requiring chronic use of pain medication
• Significant cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score < 13)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Tele-Tai Chi; Study participants will follow a 12-week simplified Tele-Tai-Chi (TC) program delivered via a mobile application.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Protocol Adherence	The percentage of Tele-Tai-Chi practice sessions completed by participants.	Percentage at post-intervention (after 12 weeks)
Retention of Study Participants	The percentage of participants who complete the study.	At study completion, 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.	At post-intervention (after 12 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Changes from baseline to post-intervention (at 12 weeks)
Timed-Up-and-Go	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.	Changes from baseline at 12 weeks (post-intervention)
Mini-Balance Evaluation Systems Test (MiniBEST)	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.	Changes from baseline at 12 weeks (post-intervention)
Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)	Qualitative interview about ease of use of the Tele-Tai Chi platform.	At post-intervention (after 12 weeks)
Activities-specific Balance Confidence (ABC) Scores	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.	Changes from baseline at 12 weeks (post-intervention)
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores	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.	Changes from baseline at 12 weeks (post-intervention)
Trail Making Test A/B Scores	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.	Changes from baseline at 12 weeks (post-intervention)
Self-Efficacy Exercise (SEE) Questionnaire	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.	Changes from baseline at 12 weeks (post-intervention)
Change in Tai Chi Proficiency Score	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.	Changes from baseline at 12 weeks (post-intervention)
Timed-Up-and-Go Dual Task	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.	Changes from baseline at 12 weeks (post-intervention)
Single Leg Stance	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.	Changes from baseline at 12 weeks (post-intervention)
Sit-to-Stand Performance	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.	Changes from baseline at 12 weeks (post-intervention)
Postural Sway and Balance	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.	Baseline and post-intervention (approximately 12 weeks)
Normalized-to-height Stride Length	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.	Baseline and post-intervention (approximately 12 weeks)
Activity Level	Physical activity (e.g. number of steps per day) derived using a wrist-worn activity monitor.	Changes from baseline at 12 weeks (post-intervention)
Controlled Oral Word Association Test (COWAT) Scores	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.	Changes from baseline at 12 weeks (post-intervention)
Change in Digit Span Test Score	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).	Changes from baseline at 12 weeks (post-intervention)
Change in Grip Strength	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.	Changes from baseline at 12 weeks (post-intervention)
Stride Time Variability	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.	Baseline and post-intervention (approximately 12 weeks)

Collaborators and Investigators

• Sponsor: Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Paolo Bonato, PhD, Spaulding Rehabilitation Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2022
• Primary Completion (Actual): June 14, 2023
• Study Completion (Actual): June 14, 2023

Study Registration Dates

• First Submitted: January 8, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 3, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021P002665

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes