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

Osteoarthritis, Knee Clinical Trial

— BFR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865692
• Other study ID #: 719-II
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: September 15, 2020

Study information

• Verified date: April 2021
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Pakistan	University of Lahore Teaching Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quadriceps muscle strength	dynamometer was used to assess strength	12 Weeks
Primary	thigh muscle size	measuring tape was used to measure	12 weeks
Primary	Pain	pain was measured through NPRS	12 weeks
Secondary	Activities of daily living		12 weeks