Clinical trial NCT05446103: The Hypoalgesic Effects of Low Load Blood Flow Restriction Training (BFRT)
Official title: The Acute Effect of Upper Limb Low Load Blood Flow Restriction Training (BFRT) on Hypoalgesia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: blood flow restriction
pressure pain threshold
exercise
training
Lead sponsor: University of West Attica
Sponsor class: OTHER
First posted: 2022-07-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Pressure pain threshold
timeFrame: Baseline and 30 minutes
Secondary outcomes:
measure: Rating of perceived exertion
timeFrame: At the end of the 1st, 2nd, 3rd and 4th set ( after 1, 2, 3 and 4 minutes respectively)
measure: Blood pressure
timeFrame: Baseline and 30 minutes
Other outcomes:
Locations:
city: Aigáleo
country: Greece
facility: University of West Attica
state: Attiki
Study officials:
affiliation: University of West Attica
name: George Gioftsos, PhD
role: STUDY_CHAIR
affiliation: University of West Attica
name: Stefanos Karanasios, PhD
role: STUDY_DIRECTOR
affiliation: University of West Attica
name: Alexia Sozeri, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.
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