| CTRI Number |
CTRI/2022/01/039083 [Registered on: 03/01/2022] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| 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
|
TO CHECK THE EFFECT BLOOD FLOW RESTRICTION EXERCISE AND PROGRESSIVE RESISTED EXERCISE ON PAIN PHYSICAL FUNCTION AND MUSCLE STRENGTH IN SUBJECTS WITH OSTEOARTHRITIS OF KNEE |
|
Scientific Title of Study
|
EFFECT OF BLOOD FLOW RESTRICTION TRAINING VERSUS PROGRESSIVE RESISTED EXERCISE ON PAIN PHYSICAL FUNCTION AND MUSCLE STRENGTH IN SUBJECTS WITH OSTEOARTHRITIS OF KNEE : A COMPARATIVE STUDY. |
| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Drashti Jani |
| Designation |
MPT Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
6, Nilkanthpark society opposite gokulnagar Dakor District - Kheda
Parul University limda waghodia parul university PO limda Ta Waghodia 391760
Vadodara
GUJARAT
388225
India |
| Phone |
8488832389 |
| Fax |
2668-260201 |
| Email |
janidrashti333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Drashti Jani |
| Designation |
MPT Student |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
6, Nilkanthpark society opposite gokulnagar Dakor District - Kheda
Parul University limda waghodia parul university PO limda Ta Waghodia 391760
GUJARAT
388225
India |
| Phone |
8488832389 |
| Fax |
2668-260201 |
| Email |
janidrashti333@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandip Parekh |
| Designation |
Assistant Professor |
| Affiliation |
Parul Institute of Physiotherapy |
| Address |
Parul University P.O Limda ,Ta. Waghodia - 391760,Dist.Vadodara ,Gujarat Parul University P.O Limda ,Ta. Waghodia 391760,Dist.Vadodara ,Gujarat Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9727081135 |
| Fax |
|
| Email |
sandip.parekh28008@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Sevashram Hospital,
Musculoskeletal Physiotherapy OPD,2nd Floor,Room No.201 |
|
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Primary Sponsor
|
| Name |
Parul Institute of Physiotherapy |
| Address |
304/A Dean Office Parul Institute of Physiotherapy,Parul University Waghodia. |
| Type of Sponsor |
Other [Private Physiotherapy College] |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Drashti Jani |
Parul Sevashram Hospital |
Musculoskeletal Physiotherapy OPD,2nd Floor,Room No.201
Vadodara
GUJARAT |
8488832389
janidrashti333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| parul university institutional ethics committee for human research (PU-IECHR) |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
blood flow restriction |
blood flow restriction training is an occlusion training in which we will partially restrict the vein flow which acts on reducing pain and increasing muscle strength |
| Comparator Agent |
progressive resisted exercise |
in this training the resisted exercises are given to reduce pain and improve muscle strength in patients with osteoarthritis of knee |
|
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Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Mild to moderate knee pain
2.Participants will be given a written consent form.
3.Knee OA of one or both knees with grade 1 or 2 (Kellgren and Lawrence classification system) based on plain x-rays
|
|
| ExclusionCriteria |
| Details |
1.History of peripheral vascular disease
2.History of neurological disease with affected the gait
3.History of undergone surgery or any invasive procedure on knee in previous 6 months.
4.History of lower extremity infection.
5.Subject who is taking medications known to increase the clotting risk
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| 1 RM is 1 repetition maximum. It is used to check the strength of muscle.In which how much person can lift the weight according we will measure the strength of muscle. |
It will be measured before 1st day of intervention and after 4 week of intervention. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
WOMAC SCORE: It is evaluate the osteoarthritis of knee joint. it is self administreted intrument.
|
WOMAC SCORE will be measure before 1st intervention and after 4 weeks of intervention
|
| VAS : It is subjective measure for pain.score will be recorded by making handwritten mark on 10 cm line that represents continuum between no pain and worst pain |
VAS will be measure before 1st intervention and after 4 week of intervention |
|
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Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/01/2022 |
| 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="0"
Months="6"
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 - NO
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Brief Summary
|
To compare effectiveness of blood flow restriction and progressive resisted exercise on pain physical function and muscle strength in subjects with osteoarthritis of knee.To determine the effect of BFR on pain in subjects with osteoarthritis of knee. To determine the effect of BFR on physical function in subjects with osteoarthritis of knee. To determine the effect of BFR on muscle strength in subjects with osteoarthritis of knee. To determine the effect of PRE on pain in subjects with osteoarthritis of knee. To determine the effect of PRE on physical function in subjects with osteoarthritis of knee. To determine the effect of PRE on muscle strength in subjects with osteoarthritis of knee. To compare the effectiveness of BFR and PRE on pain in subject with osteoarthritis of knee. To compare the effectiveness of BFR and PRE on physical function in subject with osteoarthritis of knee. To compare the effectiveness of BFR and PRE on muscle strength in subject with osteoarthritis of knee
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