| CTRI Number |
CTRI/2024/05/066785 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| 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
|
Effects of blood flow restriction training (BFRT) versus conventional endurance training on pain, ability to walk for long durations and function in patients with osteoarthritis of the knee - A randomized control trial |
|
Scientific Title of Study
|
Effects of blood flow restriction training (BFRT) versus conventional endurance training on pain, walking endurance and function in patients with knee osteoarthritis- A randomized control 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 |
Arti Premnarayan Vaidya |
| Designation |
post gradute student |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune MAHARASHTRA 411005 India |
| Phone |
7218208163 |
| Fax |
|
| Email |
vaidyaarati5@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sona Kolke |
| Designation |
Professor and HOD Musculoskeletal Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, Department of musculoskeletal physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune MAHARASHTRA 411005 India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sona Kolke |
| Designation |
Professor and HOD Musculoskeletal Department |
| Affiliation |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, Department of musculoskeletal physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005
Pune MAHARASHTRA 411005 India |
| Phone |
9371004121 |
| Fax |
|
| Email |
sona.sarma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005, India |
|
|
Primary Sponsor
|
| Name |
Arti Premnarayan Vaidya |
| Address |
Sancheti Institute for Orthopaedics and Rehabilitation college of physiotherapy, 11/12 Thube Park, Shivajinagar,
Pune – 411 005 |
| Type of Sponsor |
Other [self] |
|
|
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 Arti Premnarayan Vaidya |
Sancheti Institute for Orthopaedics and Rehabilitation College of Physiotherapy |
Sancheti Institute for
Orthopaedics and
Rehabilitation College
of Physiotherapy, Department of physiotherapy 11/12
Thube Park Shivaji
Nagar Pune 411005 Pune MAHARASHTRA |
7218208163
vaidyaarati5@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sancheti Institute for Orthopaedics and Rehabilitation Institutional Ethics Committee |
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 (BFRT) |
The experimental group will receive walking endurance with blood flow restriction training, session will be for 15- 20 min with 40-50% heart rate reserve, 3 sessions per week (on alternate days) for a period of 6 weeks. |
| Comparator Agent |
conventional endurance training |
The control group will receive conventional walking endurance training and will be for 30- 45 min with 40-50% heart rate reserve, 3 sessions per week (on alternate days) for a period of 6 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with knee OA,
Patients with Kellegren-Lawrence grade 2- 3 knee osteoarthritis,
Either gender with age group of 45- 65 years,
Knee pain on visual analog scale greater than 3 or less than or equal to 7 |
|
| ExclusionCriteria |
| Details |
Recent injury, uncontrolled hypertension, uncontrolled diabetes mellitus, clotting disorders, varicose veins, Metabolic, and endocrine disorders, which precluded exercise participation,
Intra articular infiltration with hyaluronic acid and corticosteroids infiltration over the last 6 months.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual analog scale, 6 min walk test, SF36 ( Short Form), WOMAC scale CRD version |
At baseline (0 week)
Post intervention (after 6 weeks) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Seven Day Physical Activity Recall (7 day PAR), AIMS2 (Arthritis Impact Measurement Scale), Timed up and go test, 30 sec sit to stand test
|
At baseline (0 week)
Post intervention (after 6 weeks) |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
15/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Osteoarthritis is a heterogeneous chronic progressive disease
traditionally characterized by cartilage degeneration, joint space narrowing,
and osteophyte formation. Common clinical symptoms include gradual onset knee pain worsened with activity, knee stiffness, and swelling. Weakness of the quadriceps and muscles of the feet, along with proprioceptive loss, leads to changes in balance and gait, limiting the ability to climb stairs, rise from a chair, and walk, ultimately resulting in dependency in daily living activities. Inactivity leads to decreased
aerobic capacity, endurance, and mobility, ultimately resulting in a reduction
in quality of life. Blood flow restriction training (BFRT)
provides a method to facilitate aerobic capacity with minimum duration. The
controlled compression and restricted blood flow may create an environment
where individuals can engage in exercise with less pain, which may eventually
result in improved walking endurance. However, there has been limited
exploration of the BFRT in improving the endurance in patients with knee OA. Engaging
in tolerable exercise programs is beneficial for these patients, as it helps
reduce fatigue, anxiety, and recover their self-esteem, motivation, and
well-being. With paucity of literature on blood flow restriction training on knee OA, there is a need to explore its efficacy. Thus, the current study aims to compare the effects of blood flow restriction training with conventional endurance training on pain, walking endurance, and function in patients with knee OA. Primary Hypothesis: There will be equal effects
of blood flow restriction training and conventional endurance training on pain,
walking endurance, and function in patients with knee osteoarthritis
Alternate Hypothesis: Blood flow restriction
training will have better effects on pain, walking endurance, and function in
patients with knee osteoarthritis
|