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

NCT04865692 | Completed DMC

• 1 other identifier: 719-II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Activities of daily living

  12 weeks

Study Arms (2)

Interventional group

EXPERIMENTAL

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

Other: BFRT; Other: Routine Physical Therapy

Control Group

OTHER

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

Other: Routine Physical Therapy

Interventions

BFRT 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

Interventional group

Routine Physical Therapy OTHER

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

Control Group; Interventional group

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• zoya Mujahid, DPT

  University of Lahore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: February 15, 2018
• Primary Completion: February 15, 2020
• Study Completion: September 15, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)