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Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis (BFR)

Primary Purpose

Osteoarthritis, Knee

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BFRT
Routine Physical Therapy
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Diagnosed patients of grade II knee osteoarthritis
  • Patient's age 45-65

Exclusion Criteria:

  • Bilateral knee replacement
  • Lower limb surgery in the last six months
  • Diagnosis of inflammatory joint or muscle disease
  • Chest pain during exercise or at rest; or need for supplemental oxygen
  • Pregnancy
  • Any systemic disease

Sites / Locations

  • University of Lahore Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Interventional group

Control Group

Arm Description

The interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy.

The Control group received routine physical therapy alone including knee isometrics and resisted knee extension

Outcomes

Primary Outcome Measures

Quadriceps muscle strength
dynamometer was used to assess strength
thigh muscle size
measuring tape was used to measure
Pain
pain was measured through NPRS

Secondary Outcome Measures

Activities of daily living

Full Information

First Posted
April 26, 2021
Last Updated
April 26, 2021
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT04865692
Brief Title
Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Acronym
BFR
Official Title
Effects of Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
September 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Objective is to compare the effects of routine physical therapy with and without low intensity blood flow restriction on pain and quadriceps muscle strength in women with knee osteoarthritis. A single blinded randomized controlled trial conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Defense Road, Lahore. Total 60 participants were randomly assigned in to two groups, with 30 in each group The intervention group received routine physiotherapy program combined with Low Intensity Blood Flow Restriction Technique (LI-BFR. While control group were treated with only routine physiotherapy. Dynamometer was used to assess the knee extensor strength while Knee injury and osteoarthritis outcome score was used to record any exacerbation in pain and effects of BFR on activities of daily living. Training load determined 20% of 1RM. Data analysis had done on SPSS version 23.
Detailed Description
nonparametric test Friedman test was for comparison within the groups and Mann Whitney U test was used for comparison between groups. Randomization had done through the sealed envelope method. After allocation subjects had received their treatment protocals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
The interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy.
Arm Title
Control Group
Arm Type
Other
Arm Description
The Control group received routine physical therapy alone including knee isometrics and resisted knee extension
Intervention Type
Other
Intervention Name(s)
BFRT
Intervention Description
Patients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh
Intervention Type
Other
Intervention Name(s)
Routine Physical Therapy
Intervention Description
knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold
Primary Outcome Measure Information:
Title
Quadriceps muscle strength
Description
dynamometer was used to assess strength
Time Frame
12 Weeks
Title
thigh muscle size
Description
measuring tape was used to measure
Time Frame
12 weeks
Title
Pain
Description
pain was measured through NPRS
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Activities of daily living
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Diagnosed patients of grade II knee osteoarthritis Patient's age 45-65 Exclusion Criteria: Bilateral knee replacement Lower limb surgery in the last six months Diagnosis of inflammatory joint or muscle disease Chest pain during exercise or at rest; or need for supplemental oxygen Pregnancy Any systemic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zoya Mujahid, DPT
Organizational Affiliation
University of Lahore
Official's Role
Study Chair
Facility Information:
Facility Name
University of Lahore Teaching Hospital
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Low Intensity Blood Flow Restriction on Clinical Outcomes in Women With Knee Osteoarthritis

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