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

NCT05209464 | Completed Results FDA Device

• 1 other identifier: 2021P002665
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Aging; Fall

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (19)

• Ease of Use of the Tele-Tai Chi Platform (Qualitative Interview)

  At post-intervention (after 12 weeks)

• Activities-specific Balance Confidence (ABC) Scores

  Changes from baseline at 12 weeks (post-intervention)

• Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Scores

  Changes from baseline at 12 weeks (post-intervention)

Study Arms (1)

Tele-Tai Chi

EXPERIMENTAL

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

Device: Tele-Tai Chi

Interventions

Tele-Tai Chi DEVICE

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.

Tele-Tai Chi

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02129, United States

Location

Results Point of Contact

• Title: Paolo Bonato, PhD
• Organization: Spaulding Rehabilitation Hospital

pbonato@mgh.harvard.edu

617-952-6319

Study Officials

• Paolo Bonato, PhD

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Motion Analysis Laboratory

Study Record Dates

• First Submitted: January 8, 2022
• First Posted: January 26, 2022
• Study Start: October 13, 2022
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: August 28, 2024
• Results First Posted: August 28, 2024

Record last verified: 2024-08

Locations

US (1)