Effectiveness of Blood Flow Restriction Exercise Therapy to Reduce Pain in Knee Osteoarthritis Patients
NCT ID: NCT04917952
Last Updated: 2021-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
42 participants
INTERVENTIONAL
2021-06-30
2021-08-31
Brief Summary
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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.
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Detailed Description
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The intervention group will complete a single exercise session with BFR 80%, 30% 1RM, while the control group will have sham BFR, 30% 1RM.
Pain Pressure Threshold (PPT) will be assessed with the use of a digital pressure dynamometer.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BFR group
The intervention group will receive resisted knee extension 30% of 1RM with blood flow restriction.
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.
Sham BFR group
The control group will receive resisted knee extension 30% of 1RM with sham blood flow restriction.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* VAS/NRS Knee pain ≥3/10 during activity
Exclusion Criteria
* Has followed knee exercise or kinesiotherapy program in the past 3 months
* New medicines in the past 3 months
* Any lower limb surgery in the past 6 months
* Knee arthroplasty surgery (Knee replacement)
* Any active healing process affecting walking (fracture, sprain, strain, etc.)
* Diagnosed with rheumatologic/neurologic disease affecting functionality
* Diagnosed or history of heart or vascular diseases
* Diagnosed with respiratory/metabolic disease
* Personal history of cancer
* Cognitive problems
* Pregnancy (only for female participants)
* Any other indication not to participate in exercise
ALL
No
Sponsors
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University of West Attica
OTHER
Responsible Party
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Christos Anagnostis
Principal Investigator
Principal Investigators
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George Gioftsos
Role: STUDY_DIRECTOR
University of West Attica
Central Contacts
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Other Identifiers
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36676 - 27/04/202
Identifier Type: -
Identifier Source: org_study_id
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