Two Time a Week vs. Five Time a Week Blood Flow Restriction Training Program for the Lower Extremity.

Blood Flow Restriction Training for the Quad: Comparing Daily Training vs. Training Twice a Week

This study will randomize healthy adults who regularly perform resistance training exercises for the lower extremities (2x a week) to one of three groups: a blood flow restriction (BFR) exercise group that trains 2x a week, a BFR exercise group that trains 5x a week, and a control group that does not perform any additional BFR exercise. Those randomized to the BFR groups will perform the unilateral 90-0 knee extension exercise followed by the bilateral squat. Subjects will have the BFR applied to their dominant lower extremity and will perform 4 sets (30/15/15/15 reps) per exercise. Training will initial start at 30% of 1RM with training intensity increased by 5% every 2 weeks. The training program will last 8 weeks.

Pre- and posttests include ultrasound imaging of the dominant leg rectus femoris and strength testing via hand held dynamometry.

Study Overview

• Status: Recruiting
• Conditions: Blood Flow Restriction Training
• Intervention / Treatment: Other: 5x a week BFR training group; Other: 2x a week BFR training group

• Study Type: Interventional
• Enrollment (Anticipated): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jason Brumitt, PhD; Phone Number: 5035542461; Email: jbrumitt@georgefox.edu

Study Locations

• United States
  • Oregon
    • Newberg, Oregon, United States, 97132
      • Recruiting
      • George Fox University School of Physical Therapy
      • Contact: Jason Brumitt, PhD; Phone Number: 5035542461; Email: jbrumitt@georgefox.edu
      • Contact: Jason Brumitt, PhD; Phone Number: 503-554-2461; Email: jbrumitt@georgefox.edu
    • Newberg, Oregon, United States, 97132
      • Recruiting
      • George Fox University
      • Contact: Jason Brumitt, PhD; Phone Number: 503-554-2461; Email: jbrumitt@georgefox.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: healthy adults 18 years of age who currently perform weight-lifting (i.e., resistance training) exercise 2x a week.

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Exclusion Criteria: current musculoskeletal injury; surgery to the low back or lower extremities during the prior year; one or more contraindications to blood flow restriction training.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5x a week BFR training group; Subjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh daily (5x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program.	Other: 5x a week BFR training group; This group will perform the two exercises 5x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh.
Experimental: 2x a week BFR training group; Subjects will perform 2 exercises (LAQ and squat) with BFR applied to dominant thigh twice a week (2x/wk). Exercises performed for 4 sets (30/15/15/15 reps) initially at 30% 1RM; with load increased by 5% every 2 weeks. Training program lasts for 8 weeks. They are also to continue with their regular independent exercise program.	Other: 2x a week BFR training group; This group will perform the two exercises 2x a week with blood flow restriction, set to 80% of limb occlusion pressure, applied to the dominant thigh.
No Intervention: Control group; This group will not perform any BFR exercises. They are to continue with their regular independent exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscular strength	Hand held dynamometry will be used to assess changes in strength (bilaterally) for the quadricep, hip extensors, and hip abductors.	8 weeks
Cross-sectional area of the rectus femoris	Ultrasound imaging will measure the cross-sectional area of the rectus femoris	8 weeks

Collaborators and Investigators

• Sponsor: George Fox University
• Investigators: Principal Investigator: JASON BRUMITT, PhD, College of Physical Therapy; George Fox University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: GeorgeFoxU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No