Clinical trial NCT05822466: Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults
Official title: A Remotely Delivered Tai Ji Quan Intervention to Reduce Incidence of Falls in High Risk Community-Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Accidental Fall
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
First posted: 2023-04-20
Enrollment: 620
Sex: ALL
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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.

Primary outcomes:
measure: Self-reported number of falls
timeFrame: Monthly, baseline to 6 months
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Timed up and Go (TUG)
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: 30-second chair stand
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Dual-task walking
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Trail Making (A, B)
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Category Fluency
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Forward Digit Span
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Backward Digit Span
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Proportion of fallers
timeFrame: At 6 months
Other outcomes:
measure: Activity-specific Balance Confidence (ABC)
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Pittsburgh Sleep Quality Index
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Geriatric Depression Scale
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: EuroQol EQ-5D
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: Frailty Questionnaire
timeFrame: Baseline, 4 months, 6 months, and 12 months
measure: International Physical Activity Questionnaire
timeFrame: Baseline, 4 months, 6 months, and 12 months
Locations:
city: Springfield
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
References: