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CTRI Number  CTRI/2024/12/078026 [Registered on: 12/12/2024] Trial Registered Prospectively
Last Modified On: 11/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of cardiovascular and strength training on the uneven surface on walking and balance in elderly people- 6 Week follow up study 
Scientific Title of Study   Effectiveness of circuit training on the uneven surface on gait ability and balance in the elderly population: 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  Dr Prachi Dorlikar 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Community Physiotherapy, OPD-7 & MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  8767697313  
Fax    
Email  prachidorlikar0510@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Doss Prakash S 
Designation  Professor 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Community Physiotherapy, OPD-7 & MGM Institute of Physiotherapy.

Aurangabad
MAHARASHTRA
431003
India 
Phone  9886386726  
Fax    
Email  dossprakashs@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prachi Dorlikar 
Designation  Postgraduate student 
Affiliation  MGM Institute of Physiotherapy 
Address  Department of Community Physiotherapy, OPD-7 & MGM Institute of Physiotherapy

Aurangabad
MAHARASHTRA
431003
India 
Phone  8767697313  
Fax    
Email  prachidorlikar0510@gmail.com  
 
Source of Monetary or Material Support  
MGM Institute of Physiotherapy, N-6 Cidco, Aurangabad, 431003,India 
 
Primary Sponsor  
Name  MGM Institute of Physiotherapy 
Address  N6-Cidco,Aurangabad,431003,India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prachi B Dorlikar  MGM Institute of Physiotherapy  Department of Community Physiotherapy, OPD No. 7,MGM Institute of Physiotherapy, N-6 Cidco Aurangabad MAHARASHTRA
Aurangabad
MAHARASHTRA 
8767697313

prachidorlikar0510@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MGM Institue of Physiotherapy Institutional Ethics Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R269||Unspecified abnormalities of gaitand mobility,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Control Group  Conduct Training sessions on a flat surface using similar exercises and duration as the intervention group 
Intervention  Intervention Group  Circuit Training(Uneven Surface): Set up an area with varied surfaces (e.g., foam pads, and artificial grass) to create an uneven surfaces. Design a circuit training routine including exercises targeting strength, flexibility, and balance. Exercises may include- Hip extension Squats Ladder agility Farm walk (walking with weight in hand) Alternative lunges Standing with reduced base of support( two leg balance/ one leg balance) Step up Graded reaching(forward ,sideway, backward) Ensure proper supervision and assistance to prevent falls or injuries. Gradually progress intensity and complexity of exercises based on participants abilities and tolerance. Training Sessions: Conduct supervised training sessions for both groups, typically 4 times per week for 6 weeks .each session will be 30-40 min long. Each session should include a warm-up, the circuit training routine, and a cool-down period with stretching exercises. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Score of Berg Balance scale is between 41 to 50 out of 54.
Score of Dynamic Gait Index is between 16 to 20 out of 24. 
 
ExclusionCriteria 
Details  If they are unable to walk,
severe dementia (not able to understand or follow verbal commands),
stroke,
Lover limb fracture
Cardiovascular condition
hip- or knee- replacement surgery within the previous 6 months 
 
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 
Gait- Pattern, pace & deviation
Dynamic balance
 
1st day of intervention, 21st day (after 3rd week) of intervention and last day(after 6th week) of intervention . 
 
Secondary Outcome  
Outcome  TimePoints 
Gait Speed test  1 min 
30 second chair stand test  1 min 
Berg balance scale  15 min 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   22/12/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

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

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [prachidorlikar0510@gmail.com].

  6. For how long will this data be available start date provided 30-06-2025 and end date provided 31-10-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Male or female in age between 60-75 will be taken .Eligible participant will be included for the study. Before collection of the data, Informed written and verbal consent will be taken from all the participants. The subjects will be interviewed and the information gathered about their demographic data of patients including name, age, gender, occupation, any history of systemic diseases and medications will be documented. All variables will be measured on 1st day of intervention, 21st day (after 3rd week) of intervention and last day(after 6th week) of intervention .Participant will be randomized by using block randomization technique into two group, group 1 is intervention and group 2 is control group. The intervention group will participate in circuit training conducted on uneven surfaces, such as foam pads and artificial grass. The control group will undergo similar circuit training sessions but on flat surfaces, performing the same exercises for the same duration. For both groups, training sessions will be supervised and conducted four times per week for six weeks, with each session lasting 30-40 minutes. Each session will include a warm-up phase, the main circuit training routine, and a cool-down period with stretching exercises. After the intervention period, all the outcomes will be checked to assess the progression of all the parameters. A statistical Analysis of the collected data will be conducted. A conclusion will be established based on the result of the study.
 
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