Recruiting

Blood Flow Restriction Therapy

Sponsor:

George Fox University

Code:

NCT04596020

Conditions

Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff

Muscle Weakness

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)

Study Details

Brief summary:

This 8-week study will investigate whether the application of blood flow restriction (BFR) therapy augments rotator cuff strength in untrained individuals. This is a RCT with subjects randomized to a BFR or non-BFR group. Both groups will do the same training program: 1) first sitting unilateral knee extension and standing unilateral knee curls (w/ or w/o BFR; 4 sets, 30/15/15/15 reps) and 2) scaption and sidelying external rotation (no BFR for either group; 3 sets x 15 reps each).

Conditions

Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff

Muscle Weakness

Study ID

NCT04596020

Start date

Oct 10, 2020

Status verified date

Oct, 2020

Completion date

Dec 7, 2020

Anticipated

Primary completion date

Dec 7, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

• Male or female subjects aged 18 and over

Exclusion Criteria:

  • Current neck, shoulder (or general upper extremity), and/or thoracic spine pathology;
  • Shoulder surgery (or general upper extremity surgery) during the prior 6-month time period;
  • Current lower extremity injury and/or having had a lower extremity surgery during the prior 6-month time period;
  • Cervical/thoracic spine surgery during the prior 1-year;
  • Subject having 1 or more contraindications for BFR training;
  • Under the age of 18 years.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blood Flow Restriction Group

This group will perform 2 lower extremity exercises (sitting unilateral knee extension, standing unilateral knee curl) under occlusion (i.e., BFR) for 4 sets (30/15/15/15 reps) each followed by 2 shoulder exercises (scaption and sidelying external rotation) 3 sets x 15 reps each. Exercises will be performed at 30% of 1RM.

active comparator: Non-Blood Flow Restriction Group

This group will perform the same exercises for the same volume without the use of BFR.

Interventions

Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)

Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit

Primary outcome measure

  • Strength Assessment [ Time Frame: Change in Baseline Strength (Newtons) at 8 weeks ]
  • Ultrasonography [ Time Frame: Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks ]

Central Contacts and Locations

Central contacts

Jason Brumitt, PhD

15045542461jbrumitt@georgefox.edu

Locations

George Fox University

Recruiting

Newberg, Oregon, United States, 97132

Contacts

Jason Brumitt, PhD

504-554-2461jbrumitt@georgefox.edu

Principal Investigator:

Jason Brumitt, PhD

More Information

Sponsor

George Fox University

Last update posted

Oct 22, 2020

Last verified

Oct, 2020

Keywords

  • blood flow restriction
  • shoulder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by George Fox University on 2020-10-22.