Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults

Not Applicable

Recruiting

• Conditions: Accidental Fall

• Registration Number: NCT05822466
• Lead Sponsor: Oregon Research Institute

Brief Summary

To examine two different exercise programs in reducing incidence of falls among community-dwelling older adults

Detailed Description

This is a randomized controlled trial aimed at determining the effectiveness of a virtual and home-based tai ji quan intervention vs. a virtual and home-based multimodal exercise intervention in reducing incidence of falls among community-dwelling older adults at high risk of falling

Study Timeline

• Study First Submitted: 2023-04-10
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-20
• Study Start: 2023-09-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-05
• Last Update Posted: 2024-01-09
• Primary Completion: 2028-03-30
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 620

Inclusion Criteria

• age between 65 and 90 years and
• having had 1 or more falls in the preceding 12 months or having a score ≥12 seconds on the Timed Up&Go (TUG) test.

Exclusion Criteria

• showing a diagnosis of dementia or significant cognitive impairment, as indicated by a score of <24 on the Mini Mental State Evaluation (MMSE, range: 0-30);
• being unable to ambulate independently for household distances; (c) having no medical clearance;
• having participated in any regular and structured tai ji quan-based or multicomponent exercise programs (≥2 times weekly) in the preceding 6 months;
• having any physical condition that would preclude participation in moderate-intensity exercise; and
• being unwilling to commit to the duration of the intervention or accept group assignment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Self-reported number of falls	Monthly, baseline to 6 months	This measure will reflect change in the incidence of falls as a result of intervention. Study participants will be given a falls calendar to record number of falls at home. Falls are defined as "when you land on the floor or the ground, or fall and hit objects like stairs or pieces of furniture, by accident." This information will be ascertained monthly via a phone call by study assessors

Secondary Outcome Measures

Name	Time	Method
Backward Digit Span	Baseline, 4 months, 6 months, and 12 months	Reflects change in short-term working memory with intervention. This is measured by Backward Digit Span test. During the test, the participant is asked to repeat a series of digits in reverse order. The maximum raw score is 16, with higher scores indicating better memory.
Proportion of fallers	At 6 months	Number of fallers from the participants in each intervention group
Forward Digit Span	Baseline, 4 months, 6 months, and 12 months	Reflects change in attention with intervention. This is measured by Forward Digit Span test. During the test, the participant is asked to repeat a series of digits in the order given. The maximum raw score is 16, with higher scores indicating better attention.
Short Physical Performance Battery (SPPB)	Baseline, 4 months, 6 months, and 12 months	This measure reflects change in lower extremity function with intervention. This is measured by SPPB which involves three functional tasks: static balance, gait speed, and getting in and out of a chair, with scores ranging from 0 (worst performance) to 12 (best performance).
Trail Making (A, B)	Baseline, 4 months, 6 months, and 12 months	Reflects change in executive function with intervention. This is measured by Trail Making Test (TMT) which consists of two parts (A and B). In Part A, the participant is asked to count the number (1 through 25) off the screen out loud as quickly as possible. In Part B, the participant is asked to recite numbers and letters in an alternating sequence (1-A-2-B-3-C . . . 12-L) as quickly as possible. Errors are corrected immediate with the clock running. For Parts A and B, scoring is expressed in terms of the time (in seconds) to completion. The difference in time taken to complete Part B versus Part A is calculated to form a measure of executive function, with smaller difference scores indicating better executive function.
30-second chair stand	Baseline, 4 months, 6 months, and 12 months	Reflects change in lower-extremity strength with intervention. This is measured by a 30-second chair stand test.
Category Fluency	Baseline, 4 months, 6 months, and 12 months	Reflects change in memory with intervention. This is measured by a category fluency test in which the participant is asked to generate the names of as many animals as possible in 60 seconds.
Timed up and Go (TUG)	Baseline, 4 months, 6 months, and 12 months	Reflects change in mobility performance with intervention. This is measured by TUG (measured in seconds) which assesses mobility and fall risk. The test measures the time taken by an individual to stand up from a standard chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down. Lower scores represent better lower extremity physical function.
Dual-task walking	Baseline, 4 months, 6 months, and 12 months	Reflects change in dual-task costs in gait speed with intervention. The TUG test protocol will be repeated under a dual-task condition where the participant is asked to walk while performing an arithmetic task. Lower scores on this walk indicate better performance. Dual-task walking cost is defined as the difference between single- and dual-task walking speed, expressed in percentage, with less negative values representing improvement in dual-task walking speed relative to single-task walking.
Montreal Cognitive Assessment (MoCA)	Baseline, 4 months, 6 months, and 12 months	Reflects change in global cognitive function. This is measured by MoCA which measures cognitive function of multiple domains (attention/concentration, executive functions, short term memory, language, visuospatial abilities, orientation to time and place). MoCA has a total score that ranges from 0 to 30, with higher scores representing better cognitive functioning.

Trial Locations

Locations (1)

Oregon Research Institute; 🇺🇸 Springfield, Oregon, United States