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Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients

NCT04917952 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-06-08

No results posted yet for this study

Summary

Resistance training of knee extensor muscles is being used in physiotherapy management in knee osteoarthritis (OA) to improve pain and physical function. Blood flow restriction (BFR) has been suggested to improve pain and increase muscle strength in healthy subjects and certain diseases. Although there are clinical studies suggesting improvements in knee osteoarthritis symptoms after 4-12 weeks of exercise with BFR, the acute effects of the intervention have not been known.

This study aims to assess the effectiveness of low load exercise therapy combined with BFR on acute pain reduction and within 24 hours post-intervention on people with knee OA compared to a placebo group.

This study will take place in Athens, Greece, as part of the postgraduate MSc program of the Physiotherapy department of the University of West Attica.

Conditions

Interventions

DEVICE

Blood Flow Restriction (BFR)

* Exercise: Bilateral knee extension at range 90ο-0ο * Load: 30% 1RM * BFR: Yes, 80% at both legs * Sets: 4 * Reps: 30-15-15-15 * Rest: 30'' between sets * Tempo: 2-0-2-0 Participants of the intervention group will receive an exercise protocol with blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer. Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets. In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load. Blood flow restriction will be applied at 80% by using pressure cuffs. The cuffs will be applied to the proximal thigh. Cuff pressure needed for a 100% vascular occlusion will be determined for each individual at a seated and relaxed position.

DEVICE

Sham Blood Flow Restriction (sham BFR)

* Exercise: Bilateral knee extension at range 90ο-0ο * Load: 30% 1RM * BFR: Yes, Sham BFR, 10mm Hg at both legs * Sets: 4 * Reps: 30-15-15-15 * Rest: 30'' between sets * Tempo: 2-0-2-0 Participants of the control group will receive an exercise protocol with sham blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer. Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets. In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load. Sham technique for blood flow restriction will be applied by using pressure cuffs inflated at 10mm Hg. The cuffs will be applied to the proximal thigh. Cuff pressure will be applied for each individual at a seated and relaxed position.

Sponsors & Collaborators

  • University of West Attica

    lead OTHER

Principal Investigators

  • George Gioftsos · University of West Attica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04917952 on ClinicalTrials.gov