Perceptual, Hemodynamic and Cardiovascular Responses of Two Different BFR Training Protocols

NCT05145335 | Completed

• 1 other identifier: BC-11035
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

BFR training is growing in popularity and a variety of devices are on the market for clinical use. One way in which it is thought that BFR resistance training safety can be increased is by using a BFR cuff that regulates the applied pressure to the limb during each repetition. This is thought to reduce perceptual, hemodynamic and cardiovascular responses to non-autoregulated approaches, theoretically increasing long-term compliance and safety with BFR training.

Conditions

Healthy

Keywords

Blood Flow Restriction; Strength training; Cardiovascular safety; Hemodynamics

Outcome Measures

Primary Outcomes (3)

• Change in heart rate

  Effect of leg extension exercise with blood flow restriction on the cardiovascular system

  5 weeks

• Change in blood pressure

  Effect of leg extension exercise with blood flow restriction on the hemodynamic system

  5 weeks

• Change in rate of perceived exertion (RPE)

  What is the perception of the patient when doing leg extensions with BFR

  5 weeks

Secondary Outcomes (3)

• Change in 1 repetition maximum

  5 weeks

• Change in fatiguability

  5 weeks

• change in delayed onset muscle soreness

  5 weeks

Study Arms (2)

Autoregulated cuff

EXPERIMENTAL

two sessions in which an autoregulated cuff will be used to adapt the pressure in order to keep the total pressure given constant. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue.

Device: Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training

non-autoregulated cuff

ACTIVE COMPARATOR

two sessions in which an non-autoregulated cuff will be used. In these two sessions, the pressure will not be adapted. Consequently, during each muscle contraction the pressure will rise because the cuff is not autoregulated. First session will be within a 30-15-15-15 reps protocol, the second session will be performed until max fatigue.

Device: Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training)

Interventions

Autoregulated Blood Flow Restriction Cuff (smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training DEVICE

This group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which autoregulates so when the quadriceps muscle contracts, the total amount of pressure doesn't increase, as the tourniquet will lower the pressure to keep the total amount of pressure constant.

Also known as: Kaatsu, Partial vascular occlusion

Autoregulated cuff

Non-autoregulated blood flow restriction cuff ((smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training) DEVICE

This group will undergo 2 sessions consisting of a low load leg extension exercise combined with a pressurized tourniquet which does not autoregulate so when the quadriceps muscle contracts, the total amount of pressure will increase, as the tourniquet will not lower the pressure to keep the total amount of pressure constant.

Also known as: Kaatsu, Partial vascular occlusion

non-autoregulated cuff

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy participants
• Be motivated to visit Ghent University Hospital 5 times for 30 minutes

You may not qualify if:

• Suffering from a neuromuscular disease, affecting lower limbs
• Reduced functioning or pain in the dominant leg
• Taking pain medication
• Previous cardiovascular surgery affecting lower limbs
• Symptomatic cardiovascular or hemodynamic suffering
• Pregnant
• Increased risk for DVT (genetic or history of)
• Not being able to perform physical activities, for whatever (medical) reason

Sponsors & Collaborators

• University Ghent: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (1)

University Ghent

Ghent, East-Flanders, 9000, Belgium

Location

Study Officials

• Erik Witvrouw, Prof. dr.

  University Ghent

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: December 6, 2021
• Study Start: October 2, 2021
• Primary Completion: December 23, 2021
• Study Completion: April 3, 2022
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

BE (1)