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Completed

NCT Number: NCT04540367

Blood Flow Restriction Training for The Shoulder

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy, untrained volunteers

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Baseline and 8 weeks

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

  2. Isometric Rotator Cuff Strength in General Population

    Time frame: Baseline and 8 weeks

    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.

  3. Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers

    Time frame: Baseline, 8 weeks

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

  4. Isometric Rotator Cuff Strength in Pitchers

    Time frame: Baseline, 8 weeks

    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.

Secondary outcomes

  1. Strength Endurance in General Population

    Time frame: Baseline and 8 weeks

    repetitions to fatigue (RTF) were performed for 3 exercises. Volume (repetitions x resistance, kg) was calculated for each trial as is common for strength training investigations.

    After strength testing, participants were asked to perform the first of 2 endurance tests separated by 48 to 72 hours. On both occasions, a single set of repetitions to fatigue (RTF) were performed for 3 exercises in the following order: standing cable ER at 0 of shoulder abduction, standing cable IR at 0, and dumbbell scaption with each exercise separated by a 2-minute rest period and alternating between arms (order randomized). This test was performed in both groups with and without 50% limb occlusion pressure (LOP) applied by an automated tourniquet system. A nylon cuff was placed around the most proximal portion of the upper extremity for all testing. The order of testing was randomized between the 2 testing days for each participant.

Sponsors and collaborators

Lead sponsor

The Methodist Hospital Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 7, 2020
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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