Blood Flow Restriction Training for The Shoulder

Healthy Clinical Trial

Official title:

Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04540367
• Other study ID #: Pro00017362
• Status: Completed
• Phase: N/A
• Start date: November 10, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2020
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.

Locations

Country	Name	City	State
United States	Houston Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The Methodist Hospital System

Country where clinical trial is conducted

United States, 

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine if BFR changes loss of LE lean muscle mass	LE lean muscle mass was measured in grams using DEXA	Baseline and 8 weeks
Primary	Isometric rotator cuff strength	Peak strength was measured using a hand-held dunamometer	Baseline and 8 weeks
Secondary	Strength endurance	repetitions to fatigue (RTF) were performed for 3 exercises	Baseline and 8 weeks
Secondary	Electromyography	wireless surface electromyography (EMG, Trigno, Delsys®, Natick, Massachusetts, USA) was recorded	Twice a week for 8 weeks