| CTRI Number |
CTRI/2025/07/090849 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Exercise on Older Adults with Memory Problems Living at Home |
|
Scientific Title of Study
|
Effects of Structural exercise on Community dwelling older adults with Dementia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Al Amin |
| Designation |
Undergraduate Student |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 304, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801740694995 |
| Fax |
|
| Email |
physioalamin.just@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Zahid Hossain |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801670962775 |
| Fax |
|
| Email |
mz.hossain@just.edu.bd |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Zahid Hossain |
| Designation |
Assistant Professor |
| Affiliation |
Jashore University of Science and Technology |
| Address |
Room no: 307, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology
7408
Other |
| Phone |
8801670962775 |
| Fax |
|
| Email |
mz.hossain@just.edu.bd |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore -7408, Bangladesh |
|
|
Primary Sponsor
|
| Name |
Dr Ehsanur Rahman |
| Address |
Room no: 401, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore - 7408, Bangladesh |
| Type of Sponsor |
Other [University] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Bangladesh |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Md Kabir Hossain |
Dr M R Khan Medical Center |
Level-3, Room: 301, Neurology Lab, Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology, Jashore-7408
|
8801778315139
kabir2002pt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IRB of Department of Physiotherapy & Rehabilitation, JUST |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F688||Other specified disorders of adultpersonality and behavior, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Life Style Modification |
Lifestyle modification program for 12 weeks including weekly educational sessions on diet, sleep, hydration, and fall prevention; printed handouts on healthy habits; monthly one-on-one health counseling with a nurse or counselor; and engagement in non-physical cognitive or social activities such as games, art, or group discussions. |
| Intervention |
Structured exercise program |
Structured exercise program for 12 weeks (36 sessions, 3 sessions/week) including warm-up (5 min), stretching of major muscle groups (30-sec hold, 3–5 reps), strengthening exercises for arms using dumbbells (biceps curl, forward raise, lateral raise, shoulder press), and leg exercises using sit-to-stand with weighted vest (0–12 kg, 1–3 sets of 20 reps), followed by 5-minute cool-down. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
95.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling older adults aged 60 years or above; MMSE score of 10 or more; clinically diagnosed dementia with dependence in at least one personal activity of daily living; able to stand up from a chair with armrests with help from one person or less; approved by physician; able to hear and understand instructions for assessments. |
|
| ExclusionCriteria |
| Details |
Participants will be excluded if they suffer from other neurological disease and severe diseases which would not allow participation in exercise (severe psychiatric illnesses, uncontrolled arterial hypertension, severe cardiorespiratory problems, severe
musculoskeletal problems), cancer, surgery during the previous year, severe vision and/or hearing problems, or alcohol and/or
drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Dementia Diagnosed by Mini-Mental State Examination (MMSE)
2. Depression by Geriatric Depression Scale (GDS)
3.Daily living functionality by Functional Rating Scale for Symptoms of Dementia (FRSSD).
4.Quality of life by SF-36 short edition.
5.Likert Scale for sociodemographic question |
Baseline at 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Physical function assessed by using handgrip test, Timed Up to Go (TUG), Berg Balance Scale (BBS) and Chair-Stand Test (CST) |
Baseline at 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="120"
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) |
26/07/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mz.hossain@just.edu.bd].
- For how long will this data be available start date provided 01-02-2026 and end date provided 01-02-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized controlled trial aims to evaluate the effects of a 12-week structured exercise program on physical and cognitive function in community-dwelling older adults with dementia. Participants will be randomly assigned to either an exercise group receiving strengthening, stretching, and mobility training, or a lifestyle modification group receiving health education and non-physical cognitive/social activities. Primary outcomes include balance, physical function, and daily living ability (MMSE, GDS, FRSSD, SF-36, and Likert Scale -sociodemographic). Secondary outcomes include Physical function (include handgrip test, TUG, BBS, and Chair-Stand Test at baseline, 3 and 6 months). |