Clinical trial NCT05209464: A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults
Official title: A Mobile Tai Chi Platform for Fall Prevention and Cognition in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Fall
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 8
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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).

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Protocol Adherence
timeFrame: Percentage at post-intervention (after 12 weeks)
measure: Retention of Study Participants
timeFrame: At study completion, 12 weeks from the beginning of the study
measure: System Usability Scale
timeFrame: At post-intervention (after 12 weeks)
Secondary outcomes:
Other outcomes:
measure: Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)
timeFrame: At post-intervention (after 12 weeks)
measure: Activities-specific Balance Confidence (ABC) Scores
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Physical Activity Scale for the Elderly (PASE)
timeFrame: Changes from baseline to post-intervention (at 12 weeks)
measure: Trail Making Test A/B Scores
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Self-Efficacy Exercise (SEE) Questionnaire
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Change in Tai Chi Proficiency Score
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Timed-Up-and-Go
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Timed-Up-and-Go Dual Task
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Single Leg Stance
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Sit-to-Stand Performance
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Postural Sway and Balance
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Normalized-to-height Stride Length
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Activity Level
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Mini-Balance Evaluation Systems Test (MiniBEST)
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Controlled Oral Word Association Test (COWAT) Scores
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Change in Digit Span Test Score
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Change in Grip Strength
timeFrame: Changes from baseline at 12 weeks (post-intervention)
measure: Stride Time Variability
timeFrame: Baseline and post-intervention (approximately 12 weeks)
Locations:
city: Boston
country: United States
facility: Spaulding Rehabilitation Hospital
state: Massachusetts
Study officials:
affiliation: Spaulding Rehabilitation Hospital
name: Paolo Bonato, PhD
role: PRINCIPAL_INVESTIGATOR
References: