NCT05629728

Brief Summary

The goals of this study are to examine the physical function, cognitive function, and quality of life among frail elderly residing in the community

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration 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

First Submitted

Initial submission to the registry

November 12, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2025

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

November 12, 2022

Last Update Submit

August 19, 2024

Conditions

Keywords

Tai Chifrailolder adults

Outcome Measures

Primary Outcomes (4)

  • physical function - balance

    balance was assessed using a one-leg-standing balance test (OLST)

    changes from pretest to 12 week posttest scores

  • physical function - flexibility

    flexibility was assessed by the standard sit-and-reach test (SSRT)

    changes from pretest to 12 week posttest scores

  • physical function - mobility

    mobility was assessed by the Timed Up and Go test (TUG)

    changes from pretest to 12 week posttest scores

  • cognitive function

    MOCA-K (Korean version of Montreal Cognitive Assessment) was used with the maximum score of 30. (more than 23 is normal and less than 13 is dementia, more cognitively impaired)

    changes from pretest to 12 week posttest scores

Secondary Outcomes (1)

  • Short Form health survey 12 (SF12)

    changes from pretest to 12 week posttest scores

Study Arms (2)

frail elderly-TC

EXPERIMENTAL

Tai Chi group received 12 weeks of Tai Chi exercise program with 12 week follow-up, twice a week, 60 min per session led by a trained Tai Chi instructor

Behavioral: Tai Chi exercise

frail elderly-WC

NO INTERVENTION

control group received no intervention for 12 weeks, and will be provided the chance to participate in Tai Chi program if they choose.

Interventions

Sun-style Tai Chi (21 forms)

frail elderly-TC

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • being frail (3 out of the following 5 criteria): feeling fatigued, difficulty climbing 10 stairs without help, difficulty walking 300m without help, more than 5 chronic illness, weight loss 5 % or more past 1-5 years
  • living in the community
  • able to participate in Tai Chi program twice a week

You may not qualify if:

  • participated in any formal exercise program past 6 months
  • not have transportation to come to the class

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chungnam National University

Daejeon, 35015, South Korea

RECRUITING

MeSH Terms

Conditions

Frailty

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Rhayun Song, PhD

    Chungnam National University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jisu Seo, MSN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
the assessor will be blinded for the group assignment. trained research assistant will conduct the pretest and posttest measures, not involved in providing the intervention
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: the frail older adults recruited from the community, randomly assigned to either the experimental group or the wait-list control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 12, 2022

First Posted

November 29, 2022

Study Start

July 1, 2023

Primary Completion

August 30, 2025

Study Completion

December 28, 2025

Last Updated

August 20, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

unidentified data or study protocol can be shared at the completion of publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
December, 2025
Access Criteria
researchers or reviewers with request

Locations