The Hypoalgesic Effects of Low Load Blood Flow Restriction Training (BFRT)

Study Overview
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Brief Summary
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A randomized controlled trial comparing the immediate effects of upper limb low-load blood flow restriction training (BFRT) with high load sham-BFRT on hypoalgesia and perceptual response in healthy adults

Detailed Description
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Healthy individuals will be randomized to one of two groups. A target of 40 patients for enrollment has been set for 80% power, p<0.05 (Effect size= 1). A single Intervention will be used (40 minutes). Intervention Group: A single exercise of elbow flexion with Blood Flow Restriction (30-15-15-15 reps) using 30% of 1 Repetition Maximum. Control Group: A single exercise of elbow flexion with sham Blood Flow Restriction (4x10 reps) using 65% of 1 Repetition Maximum. Primary outcome: pressure pain thresholds on quadriceps, biceps, lateral epicondyle and upper trapezius (bilateral). Secondary outcomes: difference in perceptual response (exertion), change in blood pressure

Official Title
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The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial

Conditions
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Healthy

Intervention / Treatment
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* Other: Blood flow restriction training
* Other: Sham Blood flow restriction training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI< 30 able to perform full elbow flexion and extension Exclusion Criteria: shoulder tendinopathy, cervical radiculopathy, rheumatoid arthritis, neurological deficit, serious cardiovascular diseases, venous deficiency, history of heart surgery, cancer history, breast surgery, orthopaedic surgeries during the last 6 months, thrombosis, diabetes, body mass Index ≥ 30, Crohn syndrome, family or personal history of pulmonary embolism

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFR<br>20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM) | Other: Blood flow restriction training<br>* After warming up, the load is set at 80% of the predicted 1Repetition Maximum (RM) for elbow flexors. Following each successful repetition, the load is increased by 0.5 to 1kg until patients: fail to execute the exercise through the entire range of motion; used improper form to complete the repetition; needed assistance; reported pain. We will allow a 2-3 min of rest between each attempt to ensure recovery. The session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An 40% occlusion pressure is set and subjects perform 4 sets of elbow flexion (30-15-15-15 reps) using 30% of 1 RM<br>|
| Sham Comparator: Sham BFR<br>20 healthy individuals will be assigned to perform elbow flexion exercises with high-load resistance training with sham BFR (65% of 1 RM) | Other: Sham Blood flow restriction training<br>* After warming up, the load is set at 80% of the predicted 1Repetition Maximum (RM) for elbow flexors. Following each successful repetition, the load is increased by 0.5 to 1kg until patients: fail to execute the exercise through the entire range of motion; used improper form to complete the repetition; needed assistance; reported pain. We will allow a 2-3 min of rest between each attempt to ensure recovery. The session starts by calculating the arterial occlusion pressure in the standard anatomical position. Participants rest in the standing position for 3-5 minutes before measurement to ensure restoration of blood flow circulation and a cuff is placed in the most proximal part of their dominant upper-limb. BFR application is conducted by using an automatic personalized tourniquet system (Mad-Up Pro, France). An <20% of occlusion pressure is set and subjects perform 4 sets of 10 reps of elbow flexion using 65% of 1 RM<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold | Changes between pre- and post- intervention in Pressure Pain Threshold will be measured using bilateral sites on quadriceps, upper trapezius, lateral epicondyle and biceps. The COMPACT DIGITAL ALGOMETER CAPACITIES TO: 100 lbf / 50 kgf / 500 N, will be used by an independent assessor. The assessor will be blinded to participants' group. | Baseline and 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of perceived exertion | Changes between each set of exercise of Perceived Exertion. Measurements will include a Borg 6-20 scale based on the strain and fatigue in muscles. 6 means 'no exertion at all' and 20 means 'maximal | At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively) | 
| Blood pressure | Changes in systolic and diastolic blood pressure between pre and post intervention. Blood pressure will be measured in a seated position using a electronic device (Omron) | Baseline and 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blood flow restriction, pressure pain threshold, exercise, training