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

NCT ID: NCT04865692

Last Updated: 2021-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-15
• Study Completion Date: 2020-09-15

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Interventional group

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

Group Type: EXPERIMENTAL

BFRT

Intervention Type: OTHER

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

Routine Physical Therapy

Intervention Type: OTHER

knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold

Control Group

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

Group Type: OTHER

Routine Physical Therapy

Intervention Type: OTHER

knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold

Interventions

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

Intervention Type: OTHER

Routine Physical Therapy

knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold

Intervention Type: OTHER

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zoya Mujahid, DPT

Role: STUDY_CHAIR

University of Lahore

Locations

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

719-II

Identifier Type: -

Identifier Source: org_study_id