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Tai Chi for Improving Functions of Frail Older Adults (AAproject)

Primary Purpose

Frailty

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Tai Chi exercise

About this trial

This is an interventional prevention trial for Frailty focused on measuring Tai Chi, frail, older adults

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: participated in any formal exercise program past 6 months not have transportation to come to the class

Sites / Locations

Chungnam National UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

frail elderly-TC

frail elderly-WC

Arm Description

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

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

Outcomes

Primary Outcome Measures

physical function - balance

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

physical function - flexibility

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

physical function - mobility

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

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)

Secondary Outcome Measures

Short Form health survey 12 (SF12)

Short Form health survey 12 which consists of eight dimensions: general health, physical functioning, role physical, body pain, vitality, social functioning, role emotional, and mental health. two summary scores for the physical and mental components of health-related QoL are calculated by using the weighted means for the eight domains. Higher scores indicate better health-related QoL.

Full Information

NCT ID

NCT05629728

First Posted

November 12, 2022

Last Updated

August 29, 2023

Sponsor

Chungnam National University

Collaborators

National Research Foundation of Korea

1. Study Identification

Unique Protocol Identification Number

NCT05629728

Brief Title

Tai Chi for Improving Functions of Frail Older Adults

Acronym

AAproject

Official Title

Effect of Tai Chi on Physical and Cognitive Function Among Frail Older Adults

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2023 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chungnam National University

Collaborators

National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

This randomized clinical trial recruited 100 frail older adults, assigned to either the Tai Chi group or the wait-list control group. Tai Chi intervention will be provided to the Tai Chi group for 12 weeks with 12-week follow-up and pretest and posttest measures will be conducted. The primary outcome is the function variables (physical function of balance, flexibility, mobility; cognitive function of MOCA-K) The secondary outcome is quality of life measured by SF12.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Frailty

Keywords

Tai Chi, frail, older adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

the frail older adults recruited from the community, randomly assigned to either the experimental group or the wait-list control group.

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

frail elderly-TC

Arm Type

Experimental

Arm Description

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

Arm Title

frail elderly-WC

Arm Type

No Intervention

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Tai Chi exercise

Intervention Description

Sun-style Tai Chi (21 forms)

Primary Outcome Measure Information:

Title

physical function - balance

Description

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

Time Frame