Acute Effects of Blood Flow Restriction Training to Failure on Hypoalgesia in Patients With Severe Knee Osteoarthritis Using Dynamic or Fixed Occlusion Pressure

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

About this trial

This study aims to compare the acute effects on hypoalgesia of training to failure using blood flow restriction (BFR) with dynamic occlusion versus BFR with fixed occlusion in patients with severe gonarthrosis. Two different training conditions will be performed 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. Each participant will complete two individual sessions under different training conditions, randomly assigned with a 72-hour interval between sessions.

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 to failure 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). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

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

    Device

    A single quadriceps extension exercise at 30% of 1 repetition maximum (1RM) with fixed occlusion at 50% of limb occlusion pressure (LOP). The exercise protocol will consist of 4 sets to muscle failure with 30 seconds of rest between sets and a continuous level of occlusion.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Exercise to failure under low load resistance with moderate blood occlusion and dynamic pressure.Experimental treatment 1 intervention
Group B: Exercise to failure under low load resistance with moderate blood occlusion and fixed pressure.Experimental 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

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
4

Kinesiophobia (The Tampa Scale for Kinesiophobia)

The Tampa Scale for Kinesiophobia is a questionnaire designed to assess fear of movement and avoidance of physical activity due to pain. It consists of 17 items answered on a scale of 1 (strongly disagree) to 4 (strongly agree), measuring two main factors: fear of movement and activity avoidance. The total score ranges from 17 to 68 points, with higher scores indicating greater kinesophobia.

Time frame
Before the intervention and at the end of the study

Other outcomes

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