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CTRI Number  CTRI/2025/10/096618 [Registered on: 29/10/2025] Trial Registered Prospectively
Last Modified On: 27/10/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Group Exercise in Older Adults with Dementia 
Scientific Title of Study   Effects of a Community-Based Structured Group Exercise Program on Cognitive and Physical Function among Older Adults with Dementia: A COGEX-D 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  Al Amin 
Designation  Undergraduate student 
Affiliation  Jashore University of Science and Technology 
Address  Room: 304, Physiotherapy and Rehabilitation, Jashore University of Science and Technilogy



7408
Other 
Phone  8801740694995  
Fax    
Email  physioalamin.just@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kazi Md Azman Hossain 
Designation  Physiotherapist 
Affiliation  Jashore University of Science and Technology 
Address  Room: 306, Physiotherapy and Rehabilitation, Jashore University of Science and Technilogy



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 
Address  Room: 306, Physiotherapy and Rehabilitation, Jashore University of Science and Technilogy



7408
Other 
Phone  8801660140833  
Fax    
Email  azmanhossain51@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy and Rehabilitation, Jashore University of Science and Technology 
 
Primary Sponsor  
Name  Al Amin 
Address  Physiotherapy and Rehabilitation Department, Jashore University of Science and Technology  
Type of Sponsor  Other [Self-funded] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     Bangladesh  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kazi Md Azman Hossain  M R Khan Medical Centre  Jashore University of Science and Technology (JUST), Jashore, Bangladesh

 		 8801660140833

azmanhossain51@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IRB of Department of Physiotherapy and Rehabilitation, JUST  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F039||Unspecified dementia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Community Based Structured Group Exercise Program   Participants in the experimental group will follow the 12-week lifestyle guidelines, which include weekly educational sessions on diet, hydration, sleep, and healthy ageing, along with a printed booklet for reference. In addition, they will participate in a structured, community-based group exercise programme led by an experienced physiotherapist in small groups of five, three sessions per week. The programme consists of warm-up exercises, moderate-intensity aerobic walking, upper- and lower-body strengthening exercises, static stretching, and breathing exercises, with progressive increases in intensity and duration over the 12 weeks. Exercise sessions will initially last over an hour, with subsequent sessions lasting 45 minutes to one hour, and all sessions will be monitored by a research assistant to ensure adherence and safety 
Comparator Agent  Lifestyle guidelines  Participants in the control group will follow only the 12-week lifestyle guidelines, including the weekly educational sessions and printed booklet, without any structured exercise programme. Their adherence to the lifestyle programme will be monitored, but they will not receive supervised exercise sessions. The researcher will assess compliance with the study protocol for all participants but will not be directly involved in delivering any interventions 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Participants will be included if: (1) they are community dwelling males and females aged 60 years or older, (2) they have a clinically confirmed diagnosis of dementia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM), (3) they have a Mini-Mental State Examination (MMSE) score between 10 and 24 (exclusive), (4) they are able to sit on a chair and walk 10 feet (3.05 metres) without physical assistance, (5) they consent to participate in the intervention and assessments of this study. 
 
ExclusionCriteria 
Details  Participants will be excluded if: (1) they have any neurological disorders, severe psychiatric conditions, uncontrolled arterial hypertension, or severe cardiorespiratory or musculoskeletal problems that prevent safe participation in exercise, (2) they have been diagnosed with cancer or have undergone major surgery in the past year, (3) they have severe vision or hearing impairments that interfere with communication or assessment, (4) they have a history of alcohol or drug abuse. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Cognitive function by
Mini-Mental State Examination, Addenbrooke’s Cognitive Examination Revised, Trail Making Test A–B, Digit Span test
 		 Baseline, 12 weeks and 24 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Physical function by
Senior Fitness Test, Berg Balance Scale, Timed Up and Go (TUG) Test, Instrumental Activities of Daily Living Scale
 		 Baseline, 12 weeks and 24 weeks 
 
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)   10/11/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/11/2025 
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 Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [azmanhossain51@gmail.com].

  6. For how long will this data be available start date provided 02-01-2026 and end date provided 18-12-2031?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

The COGEX-D Randomized Controlled Trial aims to assess the effects of a 12-week community-based structured group exercise program on cognitive and physical function among older adults with dementia. The study includes community-dwelling adults aged 60 years or older who have a clinically confirmed dementia diagnosis according to DSM criteria and an MMSE score between 10 and 24. Participants must also be able to sit on a chair and walk 10 feet independently. Those with severe neurological, psychiatric, cardiorespiratory, or musculoskeletal conditions that prevent safe participation in exercise, along with individuals with a history of cancer, major surgery, severe sensory impairments, or substance abuse, will be excluded. The trial features two groups: an experimental group and a control group. The experimental group will receive a 12-week intervention combining lifestyle education—focusing on diet, hydration, sleep, and healthy aging—with a structured group exercise program. This exercise regimen will include aerobic walking, strength training, stretching, and breathing exercises, with sessions occurring three times per week and led by a trained physiotherapist. The control group will follow the same lifestyle education but will not engage in the exercise program. Adherence to the program will be monitored, and cognitive and physical function will be assessed at baseline, 12 weeks, and 24 weeks using various tests, including the MMSE, Addenbrooke’s Cognitive Examination-Revised, Senior Fitness Test, Berg Balance Scale, and the Timed Up and Go Test. The study will enroll 120 participants, with a total duration of 8 months, and the outcomes will provide valuable insight into the potential benefits of structured exercise on both cognitive and physical function in older adults with dementia.

 
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