Clinical trial NCT05006261: A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
Official title: A Mobile Tai Chi Platform for Fall Prevention in Older Adults - Phase II
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: Spaulding Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a single-arm longitudinal feasibility study for older adults that involves a 12-week home-based Tai Chi program and includes four remote and/or in-person data collection visits. The investigators will collect additional clinical data in a subset of participants who agree to undergo additional assessments in the Motion Analysis Laboratory at the Spaulding Rehabilitation Hospital in Boston, MA during two in-person data collection sessions. The investigators will assess feasibility and acceptability of the Tele-Tai Chi intervention; explore changes in clinically relevant outcome measures including: physical activity, self-efficacy, quality of life, balance, and gait; and evaluate longitudinal changes in Tai Chi proficiency.

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, and gait, and evaluate changes in TC proficiency.

Over the course of the 12-week program, participants will be assessed 4 times (baseline, two follow-up assessments at 4 and 8 weeks respectively, and a final assessment at 12 weeks).

Study volunteers will be instructed to train on their own at least three times a week and to participate in 1:1 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
* TC naïve (i.e., never practiced TC)
* 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 the ability of prospective volunteers to safely participate in the study
* Active cancer
* Significant musculoskeletal conditions requiring chronic use of pain medication
* Cognitive impairment (Diagnosed with dementia (self-reported), or Montreal Cognitive Assessment (MoCA)-Blind score \< 18)

Primary outcomes:
measure: Protocol Adherence
timeFrame: Post-intervention (approximately 12 weeks)
measure: Retention
timeFrame: Through study completion, approximately 12 weeks from the beginning of the study
measure: System Usability Scale
timeFrame: Post-intervention (approximately 12 weeks)
Secondary outcomes:
Other outcomes:
measure: Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)
timeFrame: Post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Activities-specific Balance Confidence (ABC) Scores
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Physical Activity Scale for the Elderly (PASE)
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Trail Making Test A/B Scores
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Self-Efficacy Exercise (SEE) Questionnaire
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Tai Chi Proficiency Scores
timeFrame: Change from Baseline at Post-Intervention (approximately 12 weeks)
measure: Changes From Baseline in Timed-Up-and-Go
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Timed-Up-and-Go Dual Task
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Single Leg Stance
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Sit-to-Stand Performance
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Postural Sway and Balance on Both Legs With Feet Shoulder-width Apart
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Postural Sway and Balance on Both Legs With Feet Close to Each Other
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Normalized-to-height Stride Length
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Stride Time Variability
timeFrame: Baseline and post-intervention (approximately 12 weeks)
measure: Changes From Baseline in Activity Level
timeFrame: Baseline and end of intervention (approximately 12 weeks)
measure: Changes From Baseline in Mini-Balance Evaluation Systems Test (MiniBEST)
timeFrame: Baseline and end of 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: