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Acute Exercise Responses With Blood Flow Restriction Under Dynamic Pressure Compared to Fixed Pressure in Patients With Severe Gonarthrosis

ConditionSevere Knee Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-85
SponsorUniversity of Valencia

About this trial

This study aims to evaluate the acute effects of blood flow restriction (BFR) training on hypoalgesia and neuromuscular responses in patients with severe gonarthrosis by comparing the application of pressure with a dynamic versus a fixed configuration. There will be six different training conditions with varying levels of blood flow occlusion (%BFR) and percentage of load (%RM): 1) 30% RM and 50% BFR with dynamic pressure; 2) 30% RM and 50% BFR with fixed pressure; 3) 50% RM and 50% BFR with dynamic pressure; 4) 50% RM and 50% BFR with fixed pressure; 5) 30% RM and 80% BFR with dynamic pressure; 6) 30% RM and 80% BFR with fixed pressure.

Each participant will complete six individual sessions under different training conditions, assigned in a random order with a 72-hour interval between each session.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 50 and 85 years

Diagnosis of severe gonarthrosis according to the clinical and radiographic criteria of the American College of Rheumatology guidelines.

On the waiting list for unilateral total knee replacement (TKR) surgery

Disqualifiers

Pain in the contralateral leg with an intensity ≥80/100 mm on the visual analog scale (VAS) during daily activities.

Previous hip or knee replacement surgery and osteotomy within the last year.

Autoimmune arthritis

Medical conditions that contraindicate exercise.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Low-intensity resistance exercise with moderate arterial occlusion pressure and dynamic pressure.

    Device

    A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with dynamic occlusion at 50% of limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

  • Low-intensity resistance exercise with moderate arterial occlusion pressure and fixed pressure.

    Device

    A single quadriceps extension exercise at 30% of 1RM with fixed occlusion at 50% of limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

  • Moderate-intensity resistance exercise with low arterial occlusion pressure and dynamic pressure.

    Device

    A single quadriceps extension exercise at 50% of 1RM with dynamic occlusion at 30% of limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

  • Moderate-intensity resistance exercise with low arterial occlusion pressure and fixed pressure.

    Device

    A single quadriceps extension exercise at 50% of 1RM with a fixed occlusion of 30% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

  • Low-intensity resistance exercise with high arterial occlusion pressure and dynamic pressure.

    Device

    A single quadriceps extension exercise at 15% of 1RM with a dynamic occlusion of 80% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

  • Low-intensity resistance exercise with high arterial occlusion pressure and fixed pressure.

    Device

    A single quadriceps extension exercise at 15% of 1RM with a fixed occlusion of 80% of the limb occlusion pressure (LOP), performing 4 sets of 30, 15, 15, 15 repetitions with 30 seconds of rest between sets.

Treatment groups

45 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Low-load resistance exercise with moderate blood occlusion and dynamic pressure.Experimental treatment 1 intervention
Group B: Low-load resistance exercise with moderate blood occlusion and fixed pressure.Experimental treatment 1 intervention
Group C: Moderate-load resistance exercise with low blood occlusion and dynamic pressure.Experimental treatment 1 intervention
Group D: Moderate-load resistance exercise with low blood occlusion and fixed pressure.Experimental treatment 1 intervention
Group E: Low-load resistance exercise with high blood occlusion and dynamic pressureExperimental treatment 1 intervention
Group F: Low-load resistance exercise with high blood occlusion and fixed pressureExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pain intensity at rest (Visual Analogue Scale, 0-10)

Pain intensity perceived on a Visual Analogue Scale, at rest, being 0 no pain and 10 the worst pain imaginable.

Time frame
Periprocedural

Secondary outcomes

1

Pressure pain threshold

Pressure pain threshold measured in the middle deltoid (peripheral sensitivity) and tibialis anterior (central sensitivity), using an algometer

Time frame
Periprocedural
2

Perceived exertion scale (The BORG CR10 Scale)

The BORG CR10 Scale is a subjective tool used to measure the intensity of the perceived exertion of a person during an activity through a rate of perceived exertion (RPE). It is scored on a scale of 0 to 10, where 0 is no exertion and 10 is maximum exertion.

Time frame
Periprocedural
3

Surface electromyography

Surface electromyography for the study of muscle recruitment (vastus medialis and vastus lateralis)

Time frame
Periprocedural
4

Occurrence of adverse effects

Occurrence of adverse effects (e.g., pain, delayed onset muscle soreness, sudden weakness of the trained limb, redness or swelling of the trained limb, etc.) by self-report.

Time frame
Immediately after the intervention, 72 hours later, and two weeks after the study ended.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Valencia

Lead sponsor

Source ClinicalTrials.gov
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