| CTRI Number |
CTRI/2025/10/096441 [Registered on: 24/10/2025] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Tai Chi Chuan and Aerobic Exercise Program in Older Adults with Mild Cognitive Impairment |
|
Scientific Title of Study
|
Effects of a Community-Based Tai Chi Chuan and Aerobic Exercise Program on Cognitive Function, Physical Function and Quality of Life in Older Adults with Mild Cognitive Impairment: A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
Other |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kazi Md Azman Hossain |
| Designation |
Intern Physiotherapist |
| Affiliation |
Jashore University of Science and Technology (JUST), Jashore |
| Address |
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology (JUST), Jashore-7408, Bangladesh
Jashore-7408, Bangladesh
7408
India |
| Phone |
01660140833 |
| Fax |
|
| Email |
azmanhossain51@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology,Jashore -7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Kazi Md Azman Hossain |
| Address |
Jashore-7408, Bangladesh |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Jashore University of Science and Technology JUST |
Jashore-7408, Bangladesh |
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jannatul Ferdous Rikti |
M R Khan Medical Centre |
Room no: 306, 2nd
Floor, Department of
Physiotherapy and
Rehabilitation, Jashore
University of Science
and Technology
(JUST), Jashore-7408,
Bangladesh.
|
01759196610
jannatrikti192403@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board (IRB) of Department of Physiotherapy & Rehabilitation in Jashore University of Science & Technology |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G319||Degenerative disease of nervous system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Aerobic exercise group |
Participants will perform a supervised 20 low-intensity aerobic exercise program, including shoulder, arm, chest, waist, and leg movements. Each movement will last 1 minute, and the full set will be repeated three times per session, totaling approximately 1 hour. They will also adhere to the healthy lifestyle guidelines outlined in our booklet. Each supervised session will be performed in small groups of 4-5 participants. |
| Comparator Agent |
Control group (Wait-list control condition) |
Participants in the control group will not receive any exercise program and will follow the healthy lifestyle guidelines outlined in our booklet for 12 weeks. However, after completing the 12-week intervention period, they will receive one hour of Tai Chi Chuan or aerobic exercise program based on their choice for the next 12-week period (3 sessions/week) in the previous manner. |
| Intervention |
Tai chi chuan exercise group |
Participants will perform one hour of supervised 12-week (3 sessions/week), 24-form Yang-style Tai Chi Chuan exercise program. Tai chi chuan is a form of mind-body exercise that aims to integrate the musculoskeletal, sensory, and cognitive systems. It focuses on controlled, self-initiated exercise with synchronized breathing, and the movement patterns include center of gravity displacement, weight bearing and shifting, trunk and pelvic rotation, and eye-hand coordinated movements. They will also adhere to the healthy lifestyle guidelines outlined in our booklet. Each supervised session will be performed in small groups of 4-5 participants. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Participants will be included if they have mild cognitive impairment without dementia, are aged 60 years old or above, can perform the designated exercise program, have not engaged in regular exercise in the past 3 months, and have provided informed consent and volunteered for participation. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they have severe visual or auditory impairment, serious medical conditions in major organs (such as heart, lung, kidney, liver and so on), other neurological disorders, or a history of alcohol or drug abuse. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Cognitive Function by Montreal Cognitive Assessment (MOCA), Mini-Mental State Examination (MMSE) |
At baseline, 12 weeks, and 24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Physical Function by Short Physical Performance Battery (SPPB) and Timed Up and Go Test (TUG); Quality of Life by Short Form Survey (SF-36) |
At baseline, 12 weeks, and 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="0"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/11/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Applicable |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This randomized controlled trial will assess the effects of a 12 weeks community-based Tai Chi Chuan and aerobic exercise program on cognitive, physical, and quality of life outcomes in 180 older adults (60 years or above) with mild cognitive impairment in Bangladesh. Eligible participants will be randomly assigned to Tai Chi Chuan, aerobic exercise, or wait list control groups, training three times per week under supervision. Individuals with severe sensory, medical, or neurological conditions will be excluded. Outcomes (MoCA, MMSE, SPPB, TUG, SF 36) will be measured at baseline, 12, and 24 weeks to evaluate intervention effects. |