| CTRI Number |
CTRI/2024/12/077895 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
09/12/2024 |
| 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
|
Blood flow restriction training in knee osteoarthritis participants to improve pain, muscle strength, and quality of life |
|
Scientific Title of Study
|
Augmenting the impact of blood flow restriction training for management of knee osteoarthritis on pain, muscle strength and overall quality of life |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hijab Chaudhry |
| Designation |
Research Scholar |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida Uttar Pradesh
PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8445136471 |
| Fax |
|
| Email |
hijabchaudhary3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida Uttar Pradesh
PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjib Kumar Das |
| Designation |
Associate Professor |
| Affiliation |
Department of Physiotherapy, Amity Institute of Health Allied Sciences |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University
F1 LGF Sector 125 Noida Uttar Pradesh
PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8879485847 |
| Fax |
|
| Email |
skdas@amity.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Gautam Buddha Nagar Uttar Pradesh 201313 India |
|
|
Primary Sponsor
|
| Name |
Hijab Chaudhry |
| Address |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University F1 LGF Sector 125 Noida Uttar Pradesh
PIN 201313 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sanjib Kumar Das |
Department of Physiotherapy Amity Institute of Health Allied Sciences
Amity University F1 LGF Sector 125 Noida Uttar Pradesh PIN 201313 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Hijab Chaudhry |
Amity Institute of Health Allied Sciences |
Department of Physiotherapy Amity Institute of Health Allied Sciences Amity University F1 LGF Sector 125 Noida Uttar Pradesh PIN 201313
Gautam Buddha Nagar
UTTAR PRADESH |
8445136471
hijabchaudhary3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC Committee Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Noida, Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blood flow restriction training with low load resistance |
Blood flow restriction training-The therapist will apply a specialized cuff to the proximal part of the upper thigh to partially restrict blood flow to the leg. A sphygmomanometer will regulate the pressure and the pressure will be 150-180mmHg. The patient then performs low-intensity exercise (dynamic quads in high sitting) under supervision at 30-40% of 1RM 4 sets per exercise (30 reps in 1st, and 15 reps consecutively for 2nd,3rd,4th) between each rep 30-60 sec of rest and 1-2 between each exercise set. After completion of 6-week treatment parameters pain, muscle strength, physical function, and overall quality of life will be assessed at baseline,3rd week, and 6th week. |
| Comparator Agent |
Conventional physiotherapy protocol of knee osteoarthritis |
The conventional physiotherapy protocol for the management of knee osteoarthritis focuses on alleviating symptoms, improving joint function, and slowing disease progression. Management like heat therapy, ROM exercise, joint mobilization, knee strengthening and stretching exercises improve functionality through a tailored approach. This protocol is progression-based as participants progress to increase the intensity and frequency of exercises. After completion of the 6-week treatment parameters pain, muscle strength, physical function, and overall quality of life will be assessed at baseline,3rd week, and 6th week. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Both male and female
2 Age group between 40 years to 60 years
3 Participants having knee osteoarthritis confirmed by Xray and ACR criteria (Grade 2 and Grade 3)
4 Willing to participate in the study by signing informed consent
|
|
| ExclusionCriteria |
| Details |
1 Age below 40 years and above 60 years
2 Recent surgery, fracture, injury
3 Any medical condition which can affect the health status of the participants
4 History of DVT, diabetes, hypertension, varicose veins, and perivascular disease
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pain, Physical Function, Muscle Strength and Quality of Life |
Baseline assessment - before intervention
Follow-up assessment- After 3rd week
Final assessment - After 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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 3 |
|
Date of First Enrollment (India)
|
20/12/2024 |
| 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="0"
Months="4"
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
|
|
Brief Summary
|
Knee osteoarthritis (OA) is more prevalent in women aged 40–50 and men above 55. The management of knee OA poses significant challenges, as symptoms progressively affect physical, physiological, and social aspects of health, leading to pain and disability. Although international studies highlight the efficacy of blood flow restriction (BFR) training in addressing these issues, research on its application in the Indian context remains scarce. This study aims to evaluate the effectiveness and safety of BFR training in knee OA patients in India, contributing to evidence-based, culturally relevant rehabilitation practices. Aim: 1. To determine the impact of blood flow restriction training for treating knee osteoarthritis on pain and physical function. 2. To determine the impact of blood flow restriction training for treating knee osteoarthritis on muscle strength. 3. To determine the impact of blood flow restriction training for treating knee osteoarthritis on quality of life. Objectives: 1. Assess the impact of BFR training on pain and physical function in individuals with knee OA 2. Evaluate the effect of BFR training on muscle strength in knee OA patients. 3.Analyze the influence of BFR training on the quality of life (QOL) in individuals with knee OA
Hypothesis:
Null Hypothesis – Ø 1:No significant improvement in pain and physical function was observed with the application of BFR training in individuals with knee osteoarthritis. Ø 2:No significant improvement was observed in muscle strength with the application of BFR training in individuals with knee osteoarthritis. Ø 3: No significant improvement in quality of life was observed with the application of BFR training in individuals with knee osteoarthritis. Alternate Hypothesis – Ø 1:Significant improvement on pain and physical function with the application of BFR training in individuals with knee osteoarthritis. Ø 2:Significant improvement on muscle strength with the application of BFR training in individuals with knee osteoarthritis.
Ø 3:Significant improvement was observed in quality of life with the application of BFR training in individuals with knee osteoarthritis. |