NCT05710757

Brief Summary

The purpose of this study is to assess strength gains of proximal musculature in the nondominant upper extremity after implementing blood flow restriction (BFR) and myofascial release (MFR) with the supplementation of whey protein.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
9 months until next milestone

Study Start

First participant enrolled

October 16, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

March 20, 2024

Status Verified

March 1, 2024

Enrollment Period

11 months

First QC Date

January 12, 2023

Last Update Submit

March 19, 2024

Conditions

Keywords

blood flow restrictionmyofascial release

Outcome Measures

Primary Outcomes (1)

  • Scapular retraction strength

    Assess scapular retraction strength with a dynamometer

    8 weeks

Secondary Outcomes (1)

  • One repetition maximum (1RM)

    8 weeks

Other Outcomes (1)

  • Length for the pectoralis minor

    8 weeks

Study Arms (2)

Myofascial Release

EXPERIMENTAL

The Experimental group will receive a myofascial release pectoralis minor release intervention.

Other: myofascial releaseDevice: blood flow restriction

Sham Myofascial Release

SHAM COMPARATOR

The Control group will receive a sham myofascial release pectoralis minor release intervention.

Device: blood flow restrictionOther: myofascial release

Interventions

Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.

Myofascial Release

Blood flow restricted (BFR) exercise is the brief and non-continuous blockage of venous blood flow using a device that restricts the flow of blood while exercising. This technique is used to produce hypertrophy (muscle growth) and strength responses while exercising at a lighter load than traditionally required to produce a similar response.

Myofascial ReleaseSham Myofascial Release

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals between the age of 18 and 30

You may not qualify if:

  • Individuals with uncontrolled high blood pressure
  • Individuals with sickle cell anemia, current pregnancy
  • Individuals with a history of deep vein thrombosis
  • Individuals with diabetes
  • Individuals with active infection
  • Individuals with less than normal range of motion or muscle strength
  • Individuals with moderate to severe upper extremity injury in the past 12 months
  • Individuals with a current diagnosis of cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Interventions

Myofascial Release TherapyBlood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationExercise TherapyAftercareContinuity of Patient CarePatient Care

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The control group will receive a sham intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The control group will receive a sham myofascial release pectoralis minor release intervention. The experimental group will receive a myofascial release pectoralis minor release intervention. Both groups will receive blood flow restriction exercise to strength the scapula retractors.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

October 16, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

March 20, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations