- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05629728
Tai Chi and Laughing Therapy for Improving Functions of Frail Older Adults (AA project)
Effect of Tai Chi and Laughing Therapy on Physical and Cognitive Function Among Frail Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial recruited 150 frail older adults, assigned to either the intervention groups (Tai Chi vs. Laughing therapy) or the wait-list control group. Tai Chi intervention provided to the Tai Chi group for 12 weeks with 12-week follow-up and pretest and posttest measures will be conducted. Laughing therapy intervention provided 10 weekly sessions for 12 weeks.
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 SF36, and healthy aging measured by healthy aging scale.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Daejeon, South Korea, 35015
- Chungnam National University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: frail elderly-WC
control group received no intervention for 12 weeks, and will be provided the chance to participate in Tai Chi program if they choose.
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Experimental: social interaction based intervention
Laughing therapy group received 10 sessions, weekly, 60 min per session led by a certified LT instructor
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10 sessions of laughing therapy by a certified instructor
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Experimental: Exercise based intervention
Sun style Tai Chi program was provided twice per week, one hour per session for 12 weeks by a certified TC instructor
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Sun-style Tai Chi (21 forms)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical function - balance
Time Frame: changes from pretest to 12 week posttest scores
|
balance was assessed using a one-leg-standing balance test (OLST)
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changes from pretest to 12 week posttest scores
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|
physical function - flexibility
Time Frame: changes from pretest to 12 week posttest scores
|
flexibility was assessed by the standard sit-and-reach test (SSRT)
|
changes from pretest to 12 week posttest scores
|
|
physical function - mobility
Time Frame: changes from pretest to 12 week posttest scores
|
mobility was assessed by the Timed Up and Go test (TUG)
|
changes from pretest to 12 week posttest scores
|
|
cognitive function
Time Frame: changes from pretest to 12 week posttest scores
|
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)
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changes from pretest to 12 week posttest scores
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Short Form health survey 36 (SF36)
Time Frame: changes from pretest to 12 week posttest scores
|
Short Form health survey 13 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.
|
changes from pretest to 12 week posttest scores
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Rhayun Song, PhD, Chungnam National University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ChungnamNU4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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