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

NCT ID: NCT04596020

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-10
• Study Completion Date: 2020-12-07

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Non-Blood Flow Restriction Group

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Other Intervention Names

Non-Blood Flow Restriction Group (exercise without blood flow restriction)

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

George Fox University

OTHER

Sponsor Role: lead

Responsible Party

Jason Brumitt

Associate Professor of Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Brumitt, PhD

Role: PRINCIPAL_INVESTIGATOR

College of Physical Therapy, George Fox University

Locations

George Fox University

Newberg, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jason Brumitt, PhD

Role: CONTACT

jbrumitt@georgefox.edu

15045542461

Facility Contacts

Jason Brumitt, PhD

Role: primary

jbrumitt@georgefox.edu

504-554-2461

Other Identifiers

2183025

Identifier Type: -

Identifier Source: org_study_id