Blood Flow Restriction Training for The Shoulder

NCT04540367 | Completed Results FDA Device

• 1 other identifier: Pro00017362
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine if BFR-LIX promotes greater increases in shoulder lean mass, rotator cuff strength, endurance, and acute increases in shoulder muscle activation compared to LIX alone.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Determine if BFR Changes UE Lean Muscle Mass in the General Population

  UE lean muscle mass was measured in grams using DEXA. These data are reported as an average of both the left and right side.

  Baseline and 8 weeks

• Isometric Rotator Cuff Strength in General Population

  Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.

  Baseline and 8 weeks

• Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers

  Shoulder lean muscle mass was measured in grams using DEXA. These data are reported for each arm.

  Baseline, 8 weeks

• Isometric Rotator Cuff Strength in Pitchers

  Peak strength was measured using a hand-held dynamometer. A standardized procedure was used for shoulder strength testing, and all testing was performed by a sports-specialized (American Board of Physical Therapy Specialties Sports Clinical Specialist) physical therapist. A total of 6 different maximal isometric strength tests were used to measure the strength of the rotator cuff muscles in the following order: (1) seated forward flexion at 90 of shoulder abduction, (2) seated scaption at 90, (3) seated external rotation (ER) at 0, (4) seated internal rotation (IR) at 0, (5) prone ER at 90, and (6) prone IR at 90. Peak strength was measured using a microFET2 (Hoggan Scientific) hand-held dynamometer. For each isometric test, participants performed a 3-second maximal-exertion contraction against the dynamometer to determine peak strength. For each measure, tests were performed 3 times, and the highest value among the 3 trials was selected as the maximal strength value.

  Baseline, 8 weeks

Secondary Outcomes (1)

• Strength Endurance in General Population

  Baseline and 8 weeks

Study Arms (2)

No Intervention: Control

NO INTERVENTION

Participants in this group performed the exercises without the blood flow restriction therapy cuff

Experimental: BFR

EXPERIMENTAL

Participants in this group performed the exercises with the blood flow restriction therapy cuff

Device: Blood flow restriction therapy

Interventions

Blood flow restriction therapy DEVICE

The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.

Experimental: BFR

Eligibility Criteria

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

You may qualify if:

• Healthy, untrained volunteers

You may not qualify if:

• Previous history of shoulder injury occurring in the laterality of choice
• Current painful dysfunction resulting in exercise limitation
• Any health-related exercise limitation as ordered by physician
• Vascular compromise or previous vascular surgery
• Ages outside of 18-65
• Inability to access clinic and equipment
• Currently involved in structured strength training regimen of the upper extremity

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

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MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Results Point of Contact

• Title: Bradley Lambert
• Organization: Houston Methodist Hospital

bslambert@houstonmethodist.org

8326872483

Study Officials

• Patrick C McCulloch, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomized to either perform exercises with blood flow restriction therapy or without

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: September 7, 2020
• Study Start: November 10, 2017
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: August 9, 2024
• Results First Posted: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)