| 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
|
|
|
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
|
|
|
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
- 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 Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [prachidorlikar0510@gmail.com].
- 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.
- 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. |