NCT05822466

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
620

participants targeted

Target at P75+ for not_applicable

Timeline
35mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Sep 2023Mar 2029

First Submitted

Initial submission to the registry

April 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 29, 2023

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2029

Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

5.5 years

First QC Date

April 10, 2023

Last Update Submit

January 30, 2026

Conditions

Outcome Measures

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

    Monthly, baseline to 6 months

Secondary Outcomes (10)

  • Short Physical Performance Battery (SPPB)

    Baseline, 4 months, 6 months, and 12 months

  • Timed up and Go (TUG)

    Baseline, 4 months, 6 months, and 12 months

  • 30-second chair stand

    Baseline, 4 months, 6 months, and 12 months

  • Dual-task walking

    Baseline, 4 months, 6 months, and 12 months

  • Montreal Cognitive Assessment (MoCA)

    Baseline, 4 months, 6 months, and 12 months

  • +5 more secondary outcomes

Other Outcomes (6)

  • Activity-specific Balance Confidence (ABC)

    Baseline, 4 months, 6 months, and 12 months

  • Pittsburgh Sleep Quality Index

    Baseline, 4 months, 6 months, and 12 months

  • Geriatric Depression Scale

    Baseline, 4 months, 6 months, and 12 months

  • +3 more other outcomes

Study Arms (2)

Virtual tai ji quan

ACTIVE COMPARATOR

Participants participating are intervened with practice and drills of tai ji quan forms and associated movements. Training focuses on lower-extremity strength, postural control, and mobility, with an emphasis on weight bearing and weight shifting, extending and controlling the body's center of mass over its base of support; self-induced movement perturbation; gait preparation, initiation, locomotion, and termination; and sensory integration. The exercise training also emphasizes connecting tai ji quan forms to transitional movements that are associated with performing daily activities. Each session includes brief movement-based warm-ups and light breathing cool-down exercises.

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

Virtual multimodal exercise

ACTIVE COMPARATOR

Participants participating are intervened with a multicomponent exercise program that involves light walking, strength, postural control, and flexibility exercises. Walking exercises include amble forward and backward walk, long strides, heel-toe walking, narrow- and wide-base walking, and sidestepping. Strength training includes single- and multi-joint exercises such as semi-squats, lunging forward and sideways, and toe stands that involve exercising ankle dorsiflexors, knee extensors, and hip abductors. Balance training involves semi-tandem foot-standing, heel-toe and line walking, single-leg standing, alternation of the base of support, weight transfers, toe and heel movements, and various reaching and stretching movements away from the center of the base of support. Flexibility exercises include a static stretching routine of major upper and lower body muscle groups. Each session includes brief movement-based warm-ups and light breathing cool-down exercises.

Behavioral: Virtual multimodal exercise intervention (V-Multimodal)

Interventions

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

Also known as: V-TJQMBB
Virtual tai ji quan

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

Also known as: V-Multimodal
Virtual multimodal exercise

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Springfield, Oregon, 97477, United States

RECRUITING

Central Study Contacts

Fuzhong Li, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2023

First Posted

April 20, 2023

Study Start

September 29, 2023

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

March 31, 2029

Last Updated

February 3, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Locations