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CTRI Number  CTRI/2026/01/100978 [Registered on: 13/01/2026] Trial Registered Prospectively
Last Modified On: 13/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   The role of physical fitness in alleviating chronic low back pain and enhancing mental health among Bangladeshs elderly 
Scientific Title of Study   Effectiveness of specific physical fitness program on chronic low back pain and mental health of elderly in Bangladesh: A Randomized controlled trial study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Asma Islam 
Designation  Associate Professor of Physiotherapy, Bangladesh Health Professions Institute (BHPI) 
Affiliation  Bangladesh Health Professions Institute (BHPI) 
Address  Department of Physiotherapy, Bangladesh Health Professions Institute (BHPI), Savar, Dhaka



1343
Other 
Phone  880186683355  
Fax    
Email  asma.islam@crp-bangladesh.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Md Shakhaoat Hossain  
Designation  Associate Professor 
Affiliation  Jahangirnagar University 
Address  Department of Public Health and Informatics, Jahangirnagar University



1342
Other 
Phone  8801767177063  
Fax    
Email  shakhaoat@juniv.edu  
 
Details of Contact Person
Public Query  
Name  Dr Md Shakhaoat Hossain  
Designation  Associate Professor 
Affiliation  Jahangirnagar University 
Address  Department of Public Health and Informatics Jahangirnagar University



1342
Other 
Phone  8801767177063  
Fax    
Email  shakhaoat@juniv.edu  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Asma Islam 
Address  Department of Physiotherapy, Bangladesh Health Professions Institute (BHPI), chapain , Savar, Dhaka-1343, Bangladesh 
Type of Sponsor  Other [self ] 
 
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 
Dr Farjana Sharmin   Centre for the Rehabilitation of the Paralysed (CRP)  Musculoskeletal unit, Department of Physiotherapy, Centre for the Rehabilitation of the Paralysed (CRP), Savar, Dhaka 1334, Bangladesh

 		 8801614118881

farjanasharminpt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
CRP Ethical Review committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional physiotherapy approaches used with older adults with low back pain  1. Manual Therapy-5 minutes 2. Aerobic Conditioning -5 minutes Strength Training 5 minutes Flexibility exercise 5 minutes Postural Training 2 mins Functional Training 3 mins 3. Electrotherapeutic modalities- 5-10 minutes 4. Education and Self-2 minssManagement  
Intervention  Supervised physical fitness program for older adults with chronic low back pain  1. Warm Up Five Minutes 2. Aerobic Training Ten Minutes 3. Resistance And Strength Training Nine Minutes 4. Flexibility or Lumbar Mobility Two Minutes 5. Balance Training And Cool Down Two Minutes 6. Guided Deep Breathing One Minute 7. Positive Reflection One Minute  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Both males and females with chronic low back pain (more than 3 months).
Age is 60 and above for attending the CRP for rehabilitation services.
 
 
ExclusionCriteria 
Details  Persons with a serious psychological problem and unable or unwilling to respond or communicate.
Patients who are not willing to communicate or participate.
Bed bound participants
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Anthropometric measurements
Visual Analogue Scale (VAS)
The senior fitness test (Fullerton Functional Test) to assess the functional fitness of older adults & strength test
Heel Raise Test, Calf Muscle Strength (Gastrocnemius–Soleus)
Supine Bridge Test (Gluteus Maximus & Core Stability)
Hospital Anxiety and Depression Scale (HADS) 		 2 years
 
 
Secondary Outcome  
Outcome  TimePoints 
Fall risk assessment tool (FRAT)  2 years  
 
Target Sample Size   Total Sample Size="200"
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)   28/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  28/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
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 [shakhaoat@juniv.edu].

  6. For how long will this data be available start date provided 15-01-2026 and end date provided 19-02-2028?
    Response - Immediately following publication. No end date.

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

Chronic low back pain is a common and disabling condition among elderly people in Bangladesh. It often leads to reduced quality of life, poor mental health, and increased risk of falls. Conventional physiotherapy mainly provides short term symptom relief and recurrence of pain is common. Adding a structured physical fitness program may help achieve better and longer-lasting outcomes.

This randomized controlled trial aims to evaluate the effectiveness of a supervised physical fitness program combined with conventional physiotherapy in elderly individuals with chronic low back pain. The study will be conducted at the Centre for the Rehabilitation of the Paralysed in Bangladesh. A total of 200 participants aged 60 years and above with chronic low back pain will be randomly assigned to either an intervention group or a control group. The intervention group will receive conventional care along with a supervised physical fitness program for six weeks, while the control group will receive conventional care only.

Primary outcome measures will include pain intensity assessed using the Visual Analog Scale and mental health status assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes will include physical fitness assessed by the Senior Fitness Test and fall risk assessed using a Falls Risk Assessment Tool. Assessments will be conducted at baseline, after six weeks of intervention, and at six months follow-up.

The study is expected to show that the integrated physical fitness program combined with conventional care leads to greater improvement in pain reduction, mental health, physical fitness, and fall risk compared to conventional care alone. The findings may support improved long-term management strategies for chronic low back pain among the elderly population in Bangladesh.

 
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