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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04865692
Other study ID # 719-II
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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