Clinical trial NCT04540367: Blood Flow Restriction Training for The Shoulder
Official title: Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants were randomized to either perform exercises with blood flow restriction therapy or without
Primary purpose: BASIC_SCIENCE

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.

Detailed description: Healthy Volunteers: 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).

Pitchers: Twenty-eight collegiate baseball pitchers were randomized into 2 groups (BFRN=15, NOBFRN=13) that, in conjunction with offseason training, performed 8wks of shoulder LIX \[Throwing arm only; 2/wk, 4 sets (30/15/15/fatigue), 20%isometric max\] using 4 exercises \[cable external and internal rotation (ER/IR), dumbbell scaption, and side-lying dumbbell ER\]. The BFR group also trained with an automated tourniquet on the proximal arm (50%-occlusion). Regional lean mass (dual-energy x-ray absorptiometry), rotator cuff strength (dynamometry: IR0\&90, ° ER0\&90, ° Scaption, Flexion), and fastball biomechanics were assessed pre- and post-training. Achievable workload (sets × reps × resistance) was also recorded. An ANCOVA (covaried on baseline measures) repeated on training timepoint was used to detect within-group and between-group differences in outcome measures (α=0.05). For significant pairwise comparisons, effect size (ES) was calculated using a Cohen's d statistic and interpreted as: 0-0.1, negligible(N); 0.1-0.3, small(S); 0.3-0.5, moderate(M); 0.5-0.7, large(L); \>0.7, very large(VL).

Eligibility criteria: 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

Primary outcomes:
measure: Determine if BFR Changes UE Lean Muscle Mass in the General Population
timeFrame: Baseline and 8 weeks
measure: Isometric Rotator Cuff Strength in General Population
timeFrame: Baseline and 8 weeks
measure: Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers
timeFrame: Baseline, 8 weeks
measure: Isometric Rotator Cuff Strength in Pitchers
timeFrame: Baseline, 8 weeks
Secondary outcomes:
measure: Strength Endurance in General Population
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Patrick C McCulloch, MD
role: PRINCIPAL_INVESTIGATOR
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