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Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04596020
Enrollment
40
Registered
2020-10-22
Start date
2020-10-10
Completion date
2020-12-07
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

blood flow restriction, shoulder

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).

Detailed description

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 a non-BFR group. Both groups will perform the same training program 2 times a week over 8 weeks with one group performing the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant leg). Prior to starting the study the subjects will have their strength assessed by a blinded physical therapist using a hand held dynamometer. The muscles assessed will be the: quadriceps, the hamstrings, the supraspinatus, and the external rotators of the shoulder. Another blinded physical therapist will assess the cross-sectional area of the quadriceps and the supraspinatus tendon using ultrasonography. These tests will be repeated at the conclusion of the study. Subjects' training weight will be 30% of their 1 repetition max (1RM). 1RM will be determined using hand held dumbbells for the shoulder exercises and machines (knee extension, knee curl machines) for the lower extremity exercises. Subjects will be randomized to either the BFR or non-BFR group. Subjects in the BFR group will perform the lower extremity exercises under occlusion (i.e., BFR applied to the proximal thigh of the dominant lower extremity). Both groups will perform 4 sets of each lower extremity exercise for 30/15/15/15 reps. After completing the lower extremity exercises the subjects will perform the shoulder exercises (scaption, sidelying external rotation) for 3 sets of 15 repetitions each. The shoulder exercises will not be performed with BFR in either group.

Interventions

OTHERBlood 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

Sponsors

George Fox University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The assessors will not be aware of group allocation.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Strength AssessmentChange in Baseline Strength (Newtons) at 8 weeksStrength will be assessed using a hand held dynamometer and traditional manual muscle test positions
UltrasonographyChange in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 WeeksDiagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus

Countries

United States

Contacts

Primary ContactJason Brumitt, PhD
jbrumitt@georgefox.edu15045542461

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026