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Completed

NCT Number: NCT04865692

Effects of Low Intensity 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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Routine physical therapy

Other

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

Primary outcomes

  1. Quadriceps muscle strength

    Time frame: 12 Weeks

    dynamometer was used to assess strength

  2. thigh muscle size

    Time frame: 12 weeks

    measuring tape was used to measure

  3. Pain

    Time frame: 12 weeks

    pain was measured through NPRS

Secondary outcomes

  1. Activities of daily living

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

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

Acronym: BFR

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 29, 2021
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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