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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05209464
• Other study ID #: 2021P002665
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2022
• Est. completion date: August 2023

Study information

• Verified date: October 2022
• Source: Spaulding Rehabilitation Hospital
• Contact: Gloria Vergara-Diaz, MD PhD
• Phone: 617-952-6320
• Email: gvergaradiaz[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Fall

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Ease of use of the Tele-Tai Chi platform (qualitative interview)	Qualitative interview about facilitators and barriers to participation.	At post-intervention (after 12 weeks)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Tai Chi proficiency scores	Tai Chi experts will use video recordings to score proficiency using a developed instrument to score each of the five Tai Chi movements performed by participants. The minimum score is 5. The maximum score is 25 per Tai Chi exercise. Positive changes (i.e., higher scores postintervention) would represent a positive outcome.	Changes from baseline at 4 weeks, at 8 weeks and at 12 weeks (post-intervention)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Postural sway and balance	Balance on both legs with feet shoulder-width apart and balance on both legs with feet close to each other will be measured with a motion capture system. The participant is asked to hold the position for about 20 seconds.	Baseline and post-intervention (approximately 12 weeks)
Other	Normalized-to-height stride length and stride time variability	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.	Baseline and post-intervention (approximately 12 weeks)
Other	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)
Other	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)
Other	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)
Other	Digit Span Test scores	The test assess short-term memory, i.e. the number of digits a person can absorb and recall in correct serial order. Two trials of eight number sequences are read aloud. 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)
Other	Grip Strength	Investigators will measure the grip strength of both upper limbs using a hand grip dynamometer. Investigators will repeat the measure three times.	Changes from baseline at 12 weeks (post-intervention)
Primary	Protocol adherence	The percentage of Tele-Tai-Chi practice sessions completed by participants.	Percentage at post-intervention (after 12 weeks)
Primary	Retention of study participants	The percentage of participants who complete the study.	At study completion, approximately 12 months from the beginning of the study
Primary	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.	At post-intervention (after 12 weeks)