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

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: BFRT; Other: Routine Physical Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • University of Lahore Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional group; The interventional group received resisted knee extension 20% of 1RM with blood flow restriction along with routine physical therapy.	Other: BFRT; 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; Other: Routine Physical Therapy; knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold
OTHER: Control Group; The Control group received routine physical therapy alone including knee isometrics and resisted knee extension	Other: Routine Physical Therapy; knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quadriceps muscle strength	dynamometer was used to assess strength	12 Weeks
thigh muscle size	measuring tape was used to measure	12 weeks
Pain	pain was measured through NPRS	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Activities of daily living	12 weeks

Collaborators and Investigators

• Sponsor: University of Lahore
• Investigators: Study Chair: zoya Mujahid, DPT, University of Lahore

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2018
• Primary Completion (ACTUAL): February 15, 2020
• Study Completion (ACTUAL): September 15, 2020

Study Registration Dates

• First Submitted: April 26, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (ACTUAL): April 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 719-II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No