Virtual Tai ji Quan Exercise to Prevent Falls in Older Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-90
SponsorOregon Research Institute

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual tai ji quan: moving for better balance intervention (V-TJQMBB)

    Behavioral

    This intervention involves a tai ji quan exercise program, named tai ji quan: moving for better balance

  • Virtual multimodal exercise intervention (V-Multimodal)

    Behavioral

    This intervention involves a multimodal exercise program that consists of balance, strength, light walking, and stretching exercises

Treatment groups

620 Participants
are divided into 2 treatment groups
Group A: Virtual tai ji quanActive comparator 1 intervention
Group B: Virtual multimodal exerciseActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-reported number of falls

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

Time frame
Monthly, baseline to 6 months

Secondary outcomes

1

Short Physical Performance Battery (SPPB)

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).

Time frame
Baseline, 4 months, 6 months, and 12 months
2

Timed up and Go (TUG)

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.

Time frame
Baseline, 4 months, 6 months, and 12 months
3

30-second chair stand

Reflects change in lower-extremity strength with intervention. This is measured by a 30-second chair stand test.

Time frame
Baseline, 4 months, 6 months, and 12 months
4

Dual-task walking

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.

Time frame
Baseline, 4 months, 6 months, and 12 months

Other outcomes

1

Activity-specific Balance Confidence (ABC)

Reflects change in the perceptions of balance with intervention. This is measured by the ABC scale which assesses one's confidence in performing various activities of daily living without compromising one's balance. It includes such items as picking up an object from the floor, standing on a chair to reach, and walking on icy sidewalks. The scale contains 16 items scored on a range from 0% to 100% (0 indicating no confidence and 100 indicating full confidence).

Time frame
Baseline, 4 months, 6 months, and 12 months
2

Pittsburgh Sleep Quality Index

Reflects change in quality of sleep with intervention. This is measured by the Pittsburgh Sleep Quality Index which includes seven indices: subjective quality, latency (i.e., time needed to fall asleep), duration (i.e., number of hours of actual sleep per night), efficiency (i.e., total sleep time divided by time in bed, converted to a score of 0-3), sleep disturbances (e.g., waking up in the middle of the night and the like), use of sleep medication, and daytime dysfunction (e.g., having difficulty staying awake during the day). Each of the component scores ranges from 0 to 3, with the PSQI global score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality.

Time frame
Baseline, 4 months, 6 months, and 12 months
3

Geriatric Depression Scale

Reflects change in the level of depression with intervention. This is measured by GDS. The 15-item version of the GDS will be used with the scores ranging from 0 to 15. A score of 0 to 4 is considered to be within the normal range, 5 to 9 indicates mild depression, and a score of 10 or more indicates moderate to severe depression.

Time frame
Baseline, 4 months, 6 months, and 12 months
4

EuroQol EQ-5D

Reflects change in quality of life with intervention. This is measured by EuroQol EQ-5D which assesses health status in five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is measured at three levels: no problems (coded as 1), some problems (2), and extreme problems (3). An EQ-5D utility score will be calculated for each participant based on the U.S. population-based (preference-weighted) health index scores on a scale ranging from less than 0 (worst health state) to 1.0 (best or perfect health state).

Time frame
Baseline, 4 months, 6 months, and 12 months

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