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Blood Flow Restriction Training for The Shoulder

Sponsor
The Methodist Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT04540367
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
32.7
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Blood flow restriction therapy
 N/A

Detailed Description

Thirty-two healthy adults were randomized into two groups (BFRm=13,f=3, NoBFRm=10,f=6) that performed 8wks of shoulder LIX [2/wk, 4 sets (30/15/15/fatigue), 20%max] using common rotator cuff exercises [cable external rotation (ER), cable internal rotation (IR), dumbbell scaption (SCAP), and side-lying dumbbell ER (SLER)]. The BFR group also trained with an automated tourniquet placed at the proximal arm (50%-occlusion). Regional lean mass (dual-energy-xray-absorptiometry), isometric strength, and muscular endurance (repetitions-to-fatigue, RTF, 20%max, with and without 50%-occlusion) was measured before and after training. Electromyographic amplitude (EMGa) was also recorded from target shoulder muscles during endurance testing. A mixed-model ANCOVA (covaried on baseline measures) was used to detect within and between-group differences in primary outcome measures (α=0.05).

Study Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants were randomized to either perform exercises with blood flow restriction therapy or withoutParticipants were randomized to either perform exercises with blood flow restriction therapy or without
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit
Actual Study Start Date :
Nov 10, 2017
Actual Primary Completion Date :
Aug 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
No Intervention: No Intervention: Control

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

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

Device: Blood flow restriction therapy
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.

Outcome Measures

Primary Outcome Measures

  1. Determine if BFR changes loss of LE lean muscle mass [Baseline and 8 weeks]

    LE lean muscle mass was measured in grams using DEXA

  2. Isometric rotator cuff strength [Baseline and 8 weeks]

    Peak strength was measured using a hand-held dunamometer

Secondary Outcome Measures

  1. Strength endurance [Baseline and 8 weeks]

    repetitions to fatigue (RTF) were performed for 3 exercises

  2. Electromyography [Twice a week for 8 weeks]

    wireless surface electromyography (EMG, Trigno, Delsys®, Natick, Massachusetts, USA) was recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Healthy, untrained volunteers
Exclusion Criteria:

  1. Previous history of shoulder injury occurring in the laterality of choice

  2. Current painful dysfunction resulting in exercise limitation

  3. Any health-related exercise limitation as ordered by physician

  4. Vascular compromise or previous vascular surgery

  5. Ages outside of 18-65

  6. Inability to access clinic and equipment

  7. Currently involved in structured strength training regimen of the upper extremity

Contacts and Locations

Locations

Site City State Country Postal Code
1 Houston Methodist Hospital Houston Texas United States 77030

Sponsors and Collaborators

  • The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Patrick C McCulloch, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Patrick McCulloch, Principal Investigator, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT04540367
Other Study ID Numbers:
  • Pro00017362
First Posted:
Sep 7, 2020
Last Update Posted:
Sep 7, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Sep 7, 2020