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

Not Applicable

• Conditions: Healthy
• Interventions: Other: Blood flow restriction training; Other: Sham Blood flow restriction training

• Registration Number: NCT05446103
• Lead Sponsor: University of West Attica

Brief 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

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-28
• Study First Submitted QC: 2022-06-30
• Last Update Submitted: 2022-06-30
• Study Start: 2022-07
• Study First Posted: 2022-07-06
• Last Update Posted: 2022-07-06
• Primary Completion: 2022-09
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BFR	Blood flow restriction training	20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM)
Sham BFR	Sham Blood flow restriction training	20 healthy individuals will be assigned to perform elbow flexion exercises with high-load resistance training with sham BFR (65% of 1 RM)

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	Baseline and 30 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Rating of perceived exertion	At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively)	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
Blood pressure	Baseline and 30 minutes	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)

Trial Locations

Locations (1)

University of West Attica; 🇬🇷 Aigáleo, Attiki, Greece