Investigating Proximal Muscle Strength Effects by Incorpo... | NCT05710757

Studies
Investigating Proximal Muscle Strength Effects by Incorporating Proximal Muscle Lengthening

NCT05710757

Sponsor

University of Tennessee

Status

Unknown status

Last Update Posted

Mar 20, 2024Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Proximal Muscle Strength
Proximal Muscle Lengthening

Interventions

myofascial release
blood flow restriction
myofascial release

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 16, 2023Actual

Primary Completion Date

Sep 2024Estimated

Completion Date

Sep 2024Estimated

First Submitted Date

Jan 12, 2023

First Submission Date that Met QC Criteria

Jan 24, 2023

First Posted Date

Feb 2, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2024

Last Update Posted Date

Mar 20, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myofascial Release	Experimental	The Experimental group will receive a myofascial release pectoralis minor release intervention.	Other: myofascial release Device: blood flow restriction
Sham Myofascial Release	Sham Comparator	The Control group will receive a sham myofascial release pectoralis minor release intervention.	Device: blood flow restriction Other: myofascial release

Interventions

Name	Type	Description	Arm Group Labels	Other Names
myofascial release	Other	Myofascial release (MFR) is a technique that involves applying gentle sustained pressure into the myofascial connective tissue restrictions to eliminate pain and restore motion.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Scapular retraction strength	Assess scapular retraction strength with a dynamometer	8 weeks

Secondary Outcomes

Measure	Description	Time Frame
One repetition maximum (1RM)	maximum amount of weight that can be lifted one time for scapular retractors on a row machine	8 weeks

Other Outcomes

Measure	Description	Time Frame
Length for the pectoralis minor	Assess length of the pectoralis minor with a tape measure	8 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy individuals between the age of 18 and 30

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Tennessee Health Science Center		Memphis	Tennessee	38163	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000089803	Myofascial Release Therapy
D000090003	Blood Flow Restriction Therapy

Ancestor Terms

ID	Term
D008405	Massage
D064746	Therapy, Soft Tissue
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.