Clinical trial NCT04596020: Can Blood Flow Restriction Therapy Improve Strength and Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
Official title: Can Blood Flow Restriction Therapy Improve Strength and Muscle Cross-Sectional Area for Shoulder External Rotators Better Than Exercise Alone?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Can Blood Flow Restriction Therapy Augments Strength Gains in the Rotator Cuff
Muscle Weakness
Keywords: blood flow restriction
shoulder
Lead sponsor: George Fox University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Strength Assessment
timeFrame: Change in Baseline Strength (Newtons) at 8 weeks
measure: Ultrasonography
timeFrame: Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Newberg
country: United States
facility: George Fox University
state: Oregon
Study officials:
affiliation: College of Physical Therapy, George Fox University
name: Jason Brumitt, PhD
role: PRINCIPAL_INVESTIGATOR
References: