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

NCT05446103 | Unknown

• 1 other identifier: SK1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

blood flow restriction; pressure pain threshold; exercise; training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rating of perceived exertion

  At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively)

• Blood pressure

  Baseline and 30 minutes

Study Arms (2)

BFR

EXPERIMENTAL

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

Sham BFR

SHAM COMPARATOR

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

Interventions

Blood flow restriction training OTHER

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

BFR

Sham Blood flow restriction training OTHER

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

Sham BFR

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI\< 30
• able to perform full elbow flexion and extension

You may not qualify if:

• 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

Sponsors & Collaborators

• University of West Attica: lead

Study Sites (1)

University of West Attica

Aigáleo, Attica, 12243, Greece

Location

Related Publications (10)

• Bowman EN, Elshaar R, Milligan H, Jue G, Mohr K, Brown P, Watanabe DM, Limpisvasti O. Upper-extremity blood flow restriction: the proximal, distal, and contralateral effects-a randomized controlled trial. J Shoulder Elbow Surg. 2020 Jun;29(6):1267-1274. doi: 10.1016/j.jse.2020.02.003.

  PMID: 32423577 BACKGROUND

• Gearhart RE, Goss FL, Lagally KM, Jakicic JM, Gallagher J, Robertson RJ. Standardized scaling procedures for rating perceived exertion during resistance exercise. J Strength Cond Res. 2001 Aug;15(3):320-5.

  PMID: 11710658 BACKGROUND

• Hughes L, Patterson SD. The effect of blood flow restriction exercise on exercise-induced hypoalgesia and endogenous opioid and endocannabinoid mechanisms of pain modulation. J Appl Physiol (1985). 2020 Apr 1;128(4):914-924. doi: 10.1152/japplphysiol.00768.2019. Epub 2020 Feb 27.

  PMID: 32105522 BACKGROUND

• Hughes L, Patterson SD, Haddad F, Rosenblatt B, Gissane C, McCarthy D, Clarke T, Ferris G, Dawes J, Paton B. Examination of the comfort and pain experienced with blood flow restriction training during post-surgery rehabilitation of anterior cruciate ligament reconstruction patients: A UK National Health Service trial. Phys Ther Sport. 2019 Sep;39:90-98. doi: 10.1016/j.ptsp.2019.06.014. Epub 2019 Jul 2.

  PMID: 31288213 BACKGROUND

• Korakakis V, Whiteley R, Epameinontidis K. Blood Flow Restriction induces hypoalgesia in recreationally active adult male anterior knee pain patients allowing therapeutic exercise loading. Phys Ther Sport. 2018 Jul;32:235-243. doi: 10.1016/j.ptsp.2018.05.021. Epub 2018 May 31.

  PMID: 29879638 BACKGROUND

• Korakakis V, Whiteley R, Giakas G. Low load resistance training with blood flow restriction decreases anterior knee pain more than resistance training alone. A pilot randomised controlled trial. Phys Ther Sport. 2018 Nov;34:121-128. doi: 10.1016/j.ptsp.2018.09.007. Epub 2018 Sep 19.

  PMID: 30268966 BACKGROUND

• Lacruz ME, Kluttig A, Kuss O, Tiller D, Medenwald D, Nuding S, Greiser KH, Frantz S, Haerting J. Short-term blood pressure variability - variation between arm side, body position and successive measurements: a population-based cohort study. BMC Cardiovasc Disord. 2017 Jan 18;17(1):31. doi: 10.1186/s12872-017-0468-7.

  PMID: 28100183 BACKGROUND

• Calvo Lobo C, Romero Morales C, Rodriguez Sanz D, Sanz Corbalan I, Sanchez Romero EA, Fernandez Carnero J, Lopez Lopez D. Comparison of hand grip strength and upper limb pressure pain threshold between older adults with or without non-specific shoulder pain. PeerJ. 2017 Feb 9;5:e2995. doi: 10.7717/peerj.2995. eCollection 2017.

  PMID: 28289561 BACKGROUND

• Minniti MC, Statkevich AP, Kelly RL, Rigsby VP, Exline MM, Rhon DI, Clewley D. The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Am J Sports Med. 2020 Jun;48(7):1773-1785. doi: 10.1177/0363546519882652. Epub 2019 Nov 11.

  PMID: 31710505 BACKGROUND

• Patterson SD, Hughes L, Warmington S, Burr J, Scott BR, Owens J, Abe T, Nielsen JL, Libardi CA, Laurentino G, Neto GR, Brandner C, Martin-Hernandez J, Loenneke J. Blood Flow Restriction Exercise: Considerations of Methodology, Application, and Safety. Front Physiol. 2019 May 15;10:533. doi: 10.3389/fphys.2019.00533. eCollection 2019.

  PMID: 31156448 BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• George Gioftsos, PhD

  University of West Attica

  STUDY CHAIR

• Stefanos Karanasios, PhD

  University of West Attica

  STUDY DIRECTOR

• Alexia Sozeri, MSc

  University of West Attica

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanos Karanasios, PhD

CONTACT

+306947686583; skaranasios@uniwa.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Using sham blood flow restriction (A cuff will be placed on the arm with minimum pressure \<20% of arterial occlusive pressure)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 6, 2022
• Study Start: July 1, 2022
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

GR (1)