HealthyBFRTNCT05446103
The Hypoalgesic Effects of Low Load Blood Flow Restriction Training (BFRT)
A study testing Blood flow restriction training in people with Healthy, run by University of West Attica at 1 site in Greece.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood flow restriction training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGreece
- Study dates
- Jul 2022to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI< 30
- able to perform full elbow flexion and extension
Who cannot join
- shoulder tendinopathy,
- cervical radiculopathy,
- rheumatoid arthritis,
- neurological deficit,
- serious cardiovascular diseases,
- venous deficiency,
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of West Attica
Aigáleo, Attica, 12243
George Gioftsos, PhD, +30 210 538 7485, gioftsos@uniwa.gr
About this study
Official title: The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial
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
Read the 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
- Being tested
- Blood flow restriction training, Sham Blood flow restriction training
- Keywords
- blood flow restriction, pressure pain threshold, exercise, training
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
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
Sham Blood flow restriction trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| BFR | Experimental | 20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM) Receives: 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) Receives: Other: Sham Blood flow restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 30 minutes
Secondary outcomes (2)
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
Measured: 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)
Measured: Baseline and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of West Attica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefanos Karanasios, University of West Attica
- Investigators
- George Gioftsos, PhD, Study chair, University of West AtticaStefanos Karanasios, PhD, Study director, University of West AtticaAlexia Sozeri, MSc, Principal investigator, University of West Attica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446103
- Sponsor's protocol ID
- SK1
- Acronym
- BFRT
- Status last verified
- Jun 2022
- First submitted
- 28 Jun 2022
- Last updated
- 6 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 32423577Gearhart 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.
PubMed 11710658Hughes 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.
PubMed 32105522Hughes 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.
PubMed 31288213Korakakis 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.
PubMed 29879638Korakakis 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.
PubMed 30268966Lacruz 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.
PubMed 28100183Calvo 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.
PubMed 28289561Minniti 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.
PubMed 31710505Patterson 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.
PubMed 31156448
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05446103
- Acronym / sponsor ID
- BFRT / SK1
- Conditions
- Healthy
- Keywords
- blood flow restriction, pressure pain threshold, exercise, training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of West AtticaUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR | Experimental | Other: Blood flow restriction training20 healthy individuals will be assigned to perform elbow flexion exercises with low-load resistance BFR training (30% of 1 RM) |
| Sham BFR | Sham comparator | Other: Sham Blood flow restriction training20 healthy individuals will be assigned to perform elbow flexion exercises with high-load resistance training with sham BFR (65% of 1 RM) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI< 30
- able to perform full elbow flexion and extension
Key exclusion criteria (15 listed)
- shoulder tendinopathy,
- cervical radiculopathy,
- rheumatoid arthritis,
- neurological deficit,
- serious cardiovascular diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction trainingAfter 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 | BFR |
| Sham Blood flow restriction trainingAfter 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 | Other | Sham BFR |
Primary outcome
Pressure pain threshold
Time frame: 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.
2 secondary outcomes
Rating of perceived exertion
Time frame: At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively)
Blood pressure
Time frame: Baseline and 30 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
- Background: PubMed 32423577Bowman 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.
- Background: PubMed 11710658Gearhart 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.
- Background: PubMed 32105522Hughes 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.
- Background: PubMed 31288213Hughes 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.
- Background: PubMed 29879638Korakakis 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.
- Background: PubMed 30268966Korakakis 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.
- Background: PubMed 28100183Lacruz 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.
- Background: PubMed 28289561Calvo 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.
- Background: PubMed 31710505Minniti 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.
- Background: PubMed 31156448Patterson 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Gioftsos, PhD study chair
University of West Attica
Stefanos Karanasios, PhD study director
University of West Attica
Alexia Sozeri, MSc principal investigator
University of West Attica
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction training in people with Healthy, run by University of West Attica at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanos Karanasios, PhD (+306947686583, skaranasios@uniwa.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: Baseline and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05446103, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.