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

NCT05342909 | Unknown

• 1 other identifier: GeorgeFoxU
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Blood Flow Restriction Training

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

5x a week BFR training group

EXPERIMENTAL

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

2x a week BFR training group

EXPERIMENTAL

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

Control group

NO INTERVENTION

This group will not perform any BFR exercises. They are to continue with their regular independent exercise program.

Interventions

5x a week BFR training group OTHER

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.

5x a week BFR training group

2x a week BFR training group OTHER

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.

2x a week BFR training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• George Fox University: lead

Study Sites (2)

George Fox University School of Physical Therapy

Newberg, Oregon, 97132, United States

RECRUITING

George Fox University

Newberg, Oregon, 97132, United States

RECRUITING

Study Officials

• JASON BRUMITT, PhD

  College of Physical Therapy; George Fox University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Brumitt, PhD

CONTACT

5035542461; jbrumitt@georgefox.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessors are blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Physical Therapy

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 25, 2022
• Study Start: September 1, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)