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

NCT04596020 | Unknown

• 1 other identifier: 2183025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

blood flow restriction; shoulder

Outcome Measures

Primary Outcomes (2)

• Strength Assessment

  Strength will be assessed using a hand held dynamometer and traditional manual muscle test positions

  Change in Baseline Strength (Newtons) at 8 weeks

• Ultrasonography

  Diagnostic ultrasound will be used to measure the cross-sectional area of the quadriceps (specifically the Rectus Femoris) and the tendon of the supraspinatus

  Change in Baseline Cross-Sectional Area of the Quadriceps (specifically Rectus Femoris) and the Supraspinatus tendon at 8 Weeks

Study Arms (2)

Blood Flow Restriction Group

EXPERIMENTAL

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.

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

Non-Blood Flow Restriction Group

ACTIVE COMPARATOR

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

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

Interventions

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

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

Also known as: Non-Blood Flow Restriction Group (exercise without blood flow restriction)

Blood Flow Restriction Group; Non-Blood Flow Restriction Group

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18 and over

You may not qualify if:

• 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.

Sponsors & Collaborators

• George Fox University: lead

Study Sites (1)

George Fox University

Newberg, Oregon, 97132, United States

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Interventions

Exercise

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jason Brumitt, PhD

  College of Physical Therapy, George Fox University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jason Brumitt, PhD

CONTACT

15045542461; jbrumitt@georgefox.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors will not be aware of 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: October 8, 2020
• First Posted: October 22, 2020
• Study Start: October 10, 2020
• Primary Completion: December 7, 2020
• Study Completion: December 7, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)