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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05446103
Acronym
BFRT
Enrollment
40
Registered
2022-07-06
Start date
2022-07-31
Completion date
2022-12-31
Last updated
2022-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

blood flow restriction, pressure pain threshold, exercise, training

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

Interventions

OTHERBlood 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

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

Sponsors

University of West Attica
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Using sham blood flow restriction (A cuff will be placed on the arm with minimum pressure \<20% of arterial occlusive pressure)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure pain thresholdBaseline and 30 minutesChanges 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

MeasureTime frameDescription
Rating of perceived exertionAt 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 pressureBaseline and 30 minutesChanges 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)

Countries

Greece

Contacts

Primary ContactStefanos Karanasios, PhD
skaranasios@uniwa.gr+306947686583

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026