Home » Trials » SLCTR/2025/025
Effects of a 12-week Tai Chi program on physical function, lung function, pain, depression, and quality of life among older people living in the aged care homes: A feasibility study
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SLCTR Registration Number
SLCTR/2025/025
Date of Registration
The date of last modification
Jun 26, 2025
Scientific Title of Trial
Effects of a 12-week Tai Chi program on physical function, lung function, pain, depression, and quality of life among older people living in the aged care homes: A feasibility study
Public Title of Trial
Effects of a 12-week Tai Chi program on physical function, lung function, pain, depression, and quality of life among older people living in the aged care homes: A feasibility study
Disease or Health Condition(s) Studied
Older adult health
Scientific Acronym
None
Public Acronym
None
Brief title
Tai Chi interventions for older adults in aged care homes in Sri Lanka
Universal Trial Number
U1111-1320-1336
Any other number(s) assigned to the trial and issuing authority
ERC number 2024/EC/34
What is the research question being addressed?
What is the effect of a 12-week Tai Chi program on physical function, lung function, pain, depression, and quality of life among older people living in the aged care homes in Kandy District, Sri Lanka?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out in aged care homes in the Kandy district, Sri Lanka. Aged care homes will be purposively selected based on the number of participants who are willing to participate in the study.
Intervention A Tai Chi intervention will be conducted for 60 minutes per session, and four sessions per week, for 12 weeks among older people aged 60 and over. A certified Tai Chi instructor will conduct the sessions. Research assistants will help the Tai Chi instructor. A chair will be provided for participants for sitting in if anyone feels tired during the sessions. The 60-minute session will include a 5-minute welcome, a 5-minute warm-up, a 40-minute main exercise, a 5-minute cool-down, and a final 5-minute greetings and homework activity (Oh, Song, & Kim, 2023).
Inclusion criteria
All residents aged 60 and above living in the selected aged care homes
Both males and females
Exclusion criteria
Score of 18 or above on the Sinhala Version of the Mini-Mental State Examination (MMSE)
Presence of any diagnosed disorders of the central nervous system or neurodegenerative diseases such as Parkinson Disease, Huntington’s disease and Amyotrophic Lateral Sclerosis, as determined by medical records.
Diagnosis of depression or dementia as determined by medical records
Any orthopedic or cardiovascular disorders that impede ambulatory function or the ability to stand.
Severe hearing impairment that inhibits the ability to follow evaluation instructions and therapist guidance.
Severe visual impairment that affects the individual’s safety during the execution of exercises.
Any history of lower-limb fractures in the preceding 6 months.
Prior experience in Tai-Chi exercise for more than 2 months
Primary outcome(s)
|
1.
Physical function through
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[ Baseline and at the end of the 12 weeks ] |
|
2.
Lung function: Spirometry will be used to assess lung functions using a standard protocol. Parameters will include Forced Expiratory Volume in one second (FEV1), percentage predicted Forced Vital Capacity (%FVC), and FEV1 percentage predicted normal values (FEV1%). |
[ Baseline and at the end of the 12 weeks ] |
|
3.
Pain will be assessed by the Numeric Rating Scale (NRS). Any physical pain during the past 24 hours will be considered. |
[ Baseline and at the end of the 12 weeks ] |
|
4.
Depressive symptoms will be assessed using the Sinhala Version of Geriatric Depression Scale (GDS) Short Form. |
[ Baseline and at the end of the 12 weeks ] |
|
5.
Quality of Life will be assessed by the Sinhala Version of Euro Quality of Life Questionnaire (EQ5D). |
[ Baseline and at the end of the 12 weeks ] |
Secondary outcome(s)
|
1.
|
[ At the end of the 12 weeks ] |
Target number/sample size
40
Countries of recruitment
Sri Lanka
Anticipated start date
2025-07-01
Anticipated end date
2025-12-01
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
University Research Grant, University of Peradeniya - URG/2024/03/AHS
Regulatory approvals
not applicable
Status
Approved
Date of Approval
2024-10-18
Approval number
2024/EC/34
Details of Ethics Review Committee
| Name: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya. |
| Institutional Address: | Ethics Review Committee of the Faculty of Medicine, University of Peradeniya, Peradeniya |
| Telephone: | 0812396361 |
| Email: | chairperson.erc@med.pdn.ac.lk |
Contact person for Scientific Queries/Principal Investigator
E.M.J.S.K. Ekanayaka
Senior Lecturer (Grade II)
Department of nursing, Faculty of Allied Health Sciences, University of Peradeniya
0702566515
0702566515
sanya@ahs.pdn.ac.lk
Contact Person for Public Queries
E.M.J.S.K. Ekanayaka
Senior Lecturer (Grade II)
Department of nursing, Faculty of Allied Health Sciences, University of Peradeniya
0702566515
0702566515
sanya@ahs.pdn.ac.lk
Primary study sponsor/organization
University of Peradeniya
University of Peradeniya
Council and Academic Branch, University of Peradeniya, Peradeniya
081 239 2344
https://www.pdn.ac.lk/council-academic-division/
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
No
IPD sharing plan description
Not applicable.
Study protocol available
No
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
