NCT05446103

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of West Attica · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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

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

Conditions

• Healthy

Interventions

Type	Name	Description
OTHER	Blood flow restriction training	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
OTHER	Sham Blood flow restriction training	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

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-01
• Completion: 2022-12-01
• First posted: 2022-07-06
• Last updated: 2022-07-06

Locations

1 site across 1 country: Greece