Trial Outcomes & Findings for Blood Flow Restriction Training for The Shoulder (NCT NCT04540367)

Last Updated: 2024-08-09

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

69 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2024-08-09

Participant Flow

Participant milestones

Participant milestones
Measure	No Intervention: Control (General Population) Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population.	Experimental: BFR (General Population) Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered part of the general population.	No Intervention: Control (Pitchers) Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered the pitchers.	Experimental: BFR (Pitchers) Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered the pitchers.
Overall Study STARTED	16	16	18	19
Overall Study COMPLETED	16	16	13	15
Overall Study NOT COMPLETED	0	0	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	No Intervention: Control (Pitchers) Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered the pitchers.	Experimental: BFR (Pitchers) Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered the pitchers.
Overall Study Withdrawal by Subject	0	2
Overall Study COVID-19 Contact Tracing Protocols prevented completion of study activities	4	1
Overall Study Adverse Event	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No Intervention: Control (General Population) n=16 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population.	Experimental: BFR (General Population) n=16 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered part of the general population.	No Intervention: Control (Pitchers) n=13 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered the pitchers.	Experimental: BFR (Pitchers) n=15 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered the pitchers.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=16 Participants	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=16 Participants	16 Participants n=16 Participants	13 Participants n=13 Participants	15 Participants n=15 Participants	60 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=16 Participants	0 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	0 Participants n=60 Participants
Age, Continuous	25.8 years STANDARD_DEVIATION 8.3 • n=16 Participants	27.6 years STANDARD_DEVIATION 8.8 • n=16 Participants	19.8 years STANDARD_DEVIATION 1.5 • n=13 Participants	19.7 years STANDARD_DEVIATION 1.2 • n=15 Participants	26.7 years STANDARD_DEVIATION 8.5 • n=60 Participants
Sex: Female, Male Female	6 Participants n=16 Participants	3 Participants n=16 Participants	0 Participants n=13 Participants	0 Participants n=15 Participants	9 Participants n=60 Participants
Sex: Female, Male Male	10 Participants n=16 Participants	13 Participants n=16 Participants	13 Participants n=13 Participants	15 Participants n=15 Participants	51 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	16 participants n=16 Participants	16 participants n=16 Participants	13 participants n=13 Participants	15 participants n=15 Participants	32 participants n=60 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	General Population, No Intervention: Control n=16 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff	General Population, Experimental: BFR n=16 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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.
Determine if BFR Changes UE Lean Muscle Mass in the General Population Upper extremity lean muscle mass at 8 weeks	-17 g Standard Deviation 77	175 g Standard Deviation 54
Determine if BFR Changes UE Lean Muscle Mass in the General Population Shoulder region lean muscle mass at 8 weeks	96 g Standard Deviation 61	278 g Standard Deviation 90

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	General Population, No Intervention: Control n=16 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff	General Population, Experimental: BFR n=16 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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.
Isometric Rotator Cuff Strength in General Population Pre Flexion	12.1 kg Standard Deviation 0.4	12.2 kg Standard Deviation 0.4
Isometric Rotator Cuff Strength in General Population Post Flexion	11.9 kg Standard Deviation 0.4	12.8 kg Standard Deviation 0.4
Isometric Rotator Cuff Strength in General Population Pre Scaption	12 kg Standard Deviation 0.2	12.1 kg Standard Deviation 0.2
Isometric Rotator Cuff Strength in General Population Post Scaption	12.5 kg Standard Deviation 0.2	12.4 kg Standard Deviation 0.2
Isometric Rotator Cuff Strength in General Population Pre ER at 0	13.7 kg Standard Deviation 0.4	13.9 kg Standard Deviation 0.4
Isometric Rotator Cuff Strength in General Population Post ER at 0	13.9 kg Standard Deviation 0.4	14.1 kg Standard Deviation 0.4
Isometric Rotator Cuff Strength in General Population Pre IR at 0	20.1 kg Standard Deviation 0.7	20.2 kg Standard Deviation 0.7
Isometric Rotator Cuff Strength in General Population Post IR at 0	20.2 kg Standard Deviation 0.7	23.1 kg Standard Deviation 0.7
Isometric Rotator Cuff Strength in General Population Pre ER at 90	15.6 kg Standard Deviation 0.7	16 kg Standard Deviation 0.7
Isometric Rotator Cuff Strength in General Population Post ER at 90	14.7 kg Standard Deviation 0.8	16.1 kg Standard Deviation 0.7
Isometric Rotator Cuff Strength in General Population Pre IR at 90	17.4 kg Standard Deviation 0.8	17.9 kg Standard Deviation 0.8
Isometric Rotator Cuff Strength in General Population Post IR at 90	18.1 kg Standard Deviation 0.8	18.6 kg Standard Deviation 0.8

PRIMARY outcome

Timeframe: Baseline, 8 weeks

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

Outcome measures

Outcome measures
Measure	General Population, No Intervention: Control n=13 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff	General Population, Experimental: BFR n=15 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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.
Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers Shoulder Lean Muscle Mass in Throwing Arm at 8 Weeks	4307.3 g Standard Deviation 51.7	4410.1 g Standard Deviation 52
Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers Shoulder Lean Muscle Mass in Non-Throwing Arm at 8 Weeks	4347.3 g Standard Deviation 56	4346.2 g Standard Deviation 55.5
Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers Shoulder Lean Muscle Mass in Throwing Arm at Baseline	4291.8 g Standard Deviation 51.7	4279 g Standard Deviation 52
Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers Shoulder Lean Muscle Mass in Non-Throwing Arm at Baseline	4284.1 g Standard Deviation 55.9	4272.1 g Standard Deviation 55.5

PRIMARY outcome

Timeframe: Baseline, 8 weeks

Outcome measures

Outcome measures
Measure	General Population, No Intervention: Control n=13 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff	General Population, Experimental: BFR n=15 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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.
Isometric Rotator Cuff Strength in Pitchers Pre Flexion in Throwing Arm	14.8 kg Standard Deviation 0.6	14.7 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Post Flexion in Throwing Arm	13.2 kg Standard Deviation 0.6	14.0 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Pre Flexion in Non-throwing arm	14.7 kg Standard Deviation 0.6	14.6 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Post flexion in Non-Throwing Arm	14.2 kg Standard Deviation 0.6	14.0 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Pre Scaption in Throwing Arm	14.7 kg Standard Deviation 0.6	14.7 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Post Scaption in Throwing Arm	14.5 kg Standard Deviation 0.6	14.5 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Pre Scaption in Non-Throwing Arm	14.7 kg Standard Deviation 0.6	14.7 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Post Scaption in Non-Throwing Arm	14.1 kg Standard Deviation 0.6	14.3 kg Standard Deviation 0.5
Isometric Rotator Cuff Strength in Pitchers Pre ER at 0 in Throwing Arm	16.2 kg Standard Deviation 0.9	15.9 kg Standard Deviation 0.8
Isometric Rotator Cuff Strength in Pitchers Post ER at 0 in Throwing Arm	16.4 kg Standard Deviation 0.9	15.8 kg Standard Deviation 0.8
Isometric Rotator Cuff Strength in Pitchers Pre ER at 0 in Non-Throwing Arm	16.0 kg Standard Deviation 0.9	16.0 kg Standard Deviation 0.8
Isometric Rotator Cuff Strength in Pitchers Post ER at 0 in Non-Throwing Arm	16.0 kg Standard Deviation 0.9	15.9 kg Standard Deviation 0.8
Isometric Rotator Cuff Strength in Pitchers Pre IR at 0 in Throwing Arm	24.8 kg Standard Deviation 1.4	24.3 kg Standard Deviation 1.2
Isometric Rotator Cuff Strength in Pitchers Post IR at 0 in Throwing Arm	21.8 kg Standard Deviation 1.4	25.4 kg Standard Deviation 1.2
Isometric Rotator Cuff Strength in Pitchers Pre IR at 0 in Non-Throwing Arm	24.2 kg Standard Deviation 1.3	24.1 kg Standard Deviation 1.2
Isometric Rotator Cuff Strength in Pitchers Post IR at 0 in Non-Throwing Arm	22.5 kg Standard Deviation 1.3	24.4 kg Standard Deviation 1.2
Isometric Rotator Cuff Strength in Pitchers Pre ER at 90 in Throwing Arm	19.7 kg Standard Deviation 1.4	19.7 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Post ER at 90 in Throwing Arm	18.9 kg Standard Deviation 1.4	17.3 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Pre ER at 90 in Non-Throwing Arm	20.1 kg Standard Deviation 1.4	20.0 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Post ER at 90 in Non-Throwing Arm	21.1 kg Standard Deviation 1.4	17.8 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Pre IR at 90 in Throwing Arm	20.0 kg Standard Deviation 1.5	19.7 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Post IR at 90 in Throwing Arm	20.9 kg Standard Deviation 1.5	22.1 kg Standard Deviation 1.3
Isometric Rotator Cuff Strength in Pitchers Pre IR at 90 in Non-Throwing Arm	19.5 kg Standard Deviation 1.5	19.9 kg Standard Deviation 1.4
Isometric Rotator Cuff Strength in Pitchers Post IR at 90 in Non-Throwing Arm	21.4 kg Standard Deviation 1.5	20.4 kg Standard Deviation 1.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	General Population, No Intervention: Control n=16 Participants Participants in this group performed the exercises without the blood flow restriction therapy cuff	General Population, Experimental: BFR n=16 Participants Participants in this group performed the exercises with the blood flow restriction therapy cuff 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.
Strength Endurance in General Population Cable ER - Pre at 50% LOP	97.3 kg Standard Deviation 10.8	94.1 kg Standard Deviation 10.9
Strength Endurance in General Population Cable ER Post at 50% LOP	155.1 kg Standard Deviation 10.8	155.1 kg Standard Deviation 10.9
Strength Endurance in General Population Cable IR - Pre at 50% LOP	230.7 kg Standard Deviation 19.5	230.9 kg Standard Deviation 19.5
Strength Endurance in General Population Cable IR - Post at 50% LOP	305.9 kg Standard Deviation 19.5	389.5 kg Standard Deviation 19.6
Strength Endurance in General Population Scaption - Pre at 50% LOP	134.8 kg Standard Deviation 18.8	137 kg Standard Deviation 18.9
Strength Endurance in General Population Scaption - Post at 50% LOP	211.2 kg Standard Deviation 18.8	240.3 kg Standard Deviation 18.8
Strength Endurance in General Population Cable ER - Pre without LOP	99.5 kg Standard Deviation 12.8	96.2 kg Standard Deviation 10.8
Strength Endurance in General Population Cable ER Post without LOP	157.2 kg Standard Deviation 10.7	155.9 kg Standard Deviation 10.8
Strength Endurance in General Population Cable IR - Pre at without LOP	249.1 kg Standard Deviation 17.8	249.3 kg Standard Deviation 17.9
Strength Endurance in General Population Cable IR - Post at without LOP	342.2 kg Standard Deviation 17.8	407 kg Standard Deviation 17.9
Strength Endurance in General Population Scaption - Pre at without LOP	138.6 kg Standard Deviation 18.3	140.2 kg Standard Deviation 18.4
Strength Endurance in General Population Scaption - Post without LOP	222.7 kg Standard Deviation 18.4	231.7 kg Standard Deviation 18.4

Adverse Events

No Intervention: Control (General Population)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: BFR (General Population)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention: Control (Pitchers)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental: BFR (Pitchers)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	No Intervention: Control (General Population) n=16 participants at risk Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered part of the general population.	Experimental: BFR (General Population) n=16 participants at risk Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered part of the general population.	No Intervention: Control (Pitchers) n=13 participants at risk Participants in this group performed the exercises without the blood flow restriction therapy cuff. Additionally, these participants are considered the pitchers.	Experimental: BFR (Pitchers) n=15 participants at risk Participants in this group performed the exercises with the blood flow restriction therapy cuff 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. Additionally, these participants are considered the pitchers.
Injury, poisoning and procedural complications Other	0.00% 0/16 • The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks. It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.	6.2% 1/16 • Number of events 1 • The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks. It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.	0.00% 0/13 • The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks. It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.	0.00% 0/15 • The AE was a single episode of a muscle strain. The subject was monitored from the time of the event through study completion, an average of 8 weeks. It was a muscle strain as the volunteer had an untrained arm. It was treated with ibuprofen, the subject was completely fine and able to finish the study.

Other adverse events

Adverse event data not reported

Additional Information

Bradley Lambert

Houston Methodist Hospital

Phone: 8326872483

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place