HealthyNCT04540367
Blood Flow Restriction Training for The Shoulder
A study testing Blood flow restriction therapy in people with Healthy, run by The Methodist Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Blood flow restriction therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2017to 1 Aug 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy, untrained volunteers
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit
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.
Read the 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).
- Conditions
- Healthy
- Being tested
- Blood flow restriction therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control | No intervention | Participants in this group performed the exercises without the blood flow restriction therapy cuff |
| Experimental: BFR | Experimental | Participants in this group performed the exercises with the blood flow restriction therapy cuff Receives: Device: Blood flow restriction therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if BFR Changes UE Lean Muscle Mass in the General Population
UE lean muscle mass was measured in grams using DEXA. These data are reported as an average of both the left and right side.
Measured: Baseline and 8 weeks
Isometric Rotator Cuff Strength in General Population
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.
Measured: Baseline and 8 weeks
Determine if BFR Changes Shoulder Lean Muscle Mass in Pitchers
Shoulder lean muscle mass was measured in grams using DEXA. These data are reported for each arm.
Measured: Baseline, 8 weeks
Isometric Rotator Cuff Strength in Pitchers
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.
Measured: Baseline, 8 weeks
Secondary outcomes (1)
Strength Endurance in General Population
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.
Measured: Baseline and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start10 Nov 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomized to either perform exercises with blood flow restriction therapy or without
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
- Investigators
- Patrick C McCulloch, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540367
- Sponsor's protocol ID
- Pro00017362
- Status last verified
- Aug 2024
- First submitted
- 26 Aug 2020
- Last updated
- 9 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Adams GR. Invited Review: Autocrine/paracrine IGF-I and skeletal muscle adaptation. J Appl Physiol (1985). 2002 Sep;93(3):1159-67. doi: 10.1152/japplphysiol.01264.2001.
PubMed 12183514Burd NA, Holwerda AM, Selby KC, West DW, Staples AW, Cain NE, Cashaback JG, Potvin JR, Baker SK, Phillips SM. Resistance exercise volume affects myofibrillar protein synthesis and anabolic signalling molecule phosphorylation in young men. J Physiol. 2010 Aug 15;588(Pt 16):3119-30. doi: 10.1113/jphysiol.2010.192856. Epub 2010 Jun 25.
PubMed 20581041Cifrek M, Medved V, Tonkovic S, Ostojic S. Surface EMG based muscle fatigue evaluation in biomechanics. Clin Biomech (Bristol). 2009 May;24(4):327-40. doi: 10.1016/j.clinbiomech.2009.01.010. Epub 2009 Mar 13.
PubMed 19285766Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.
PubMed 17909396Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014 Oct;23(10):1454-61. doi: 10.1016/j.jse.2014.01.006. Epub 2014 Apr 13.
PubMed 24726484Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
PubMed 26294055Cornish SM, Bugera EM, Duhamel TA, Peeler JD, Anderson JE. A focused review of myokines as a potential contributor to muscle hypertrophy from resistance-based exercise. Eur J Appl Physiol. 2020 May;120(5):941-959. doi: 10.1007/s00421-020-04337-1. Epub 2020 Mar 6.
PubMed 32144492Counts BR, Dankel SJ, Barnett BE, Kim D, Mouser JG, Allen KM, Thiebaud RS, Abe T, Bemben MG, Loenneke JP. Influence of relative blood flow restriction pressure on muscle activation and muscle adaptation. Muscle Nerve. 2016 Mar;53(3):438-45. doi: 10.1002/mus.24756. Epub 2015 Dec 29.
PubMed 26137897Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
PubMed 26446893Figueiredo VC, de Salles BF, Trajano GS. Volume for Muscle Hypertrophy and Health Outcomes: The Most Effective Variable in Resistance Training. Sports Med. 2018 Mar;48(3):499-505. doi: 10.1007/s40279-017-0793-0.
PubMed 29022275Glowacki SP, Martin SE, Maurer A, Baek W, Green JS, Crouse SF. Effects of resistance, endurance, and concurrent exercise on training outcomes in men. Med Sci Sports Exerc. 2004 Dec;36(12):2119-27. doi: 10.1249/01.mss.0000147629.74832.52.
PubMed 15570149Hollman JH, Berling TA, Crum EO, Miller KM, Simmons BT, Youdas JW. Do Verbal and Tactile Cueing Selectively Alter Gluteus Maximus and Hamstring Recruitment During a Supine Bridging Exercise in Active Females? A Randomized Controlled Trial. J Sport Rehabil. 2018 Mar 1;27(2):138-143. doi: 10.1123/jsr.2016-0130. Epub 2018 Mar 1.
PubMed 28121207Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.
PubMed 28259850Hughes L, Rosenblatt B, Gissane C, Paton B, Patterson SD. Interface pressure, perceptual, and mean arterial pressure responses to different blood flow restriction systems. Scand J Med Sci Sports. 2018 Jul;28(7):1757-1765. doi: 10.1111/sms.13092. Epub 2018 Apr 30.
PubMed 29630752Illyes A, Kiss RM. Shoulder muscle activity during pushing, pulling, elevation and overhead throw. J Electromyogr Kinesiol. 2005 Jun;15(3):282-9. doi: 10.1016/j.jelekin.2004.10.005.
PubMed 15763675
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training for The Shoulder: A Case for Proximal Benefit
- ClinicalTrials.gov ID
- NCT04540367
- Acronym / sponsor ID
- Pro00017362
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 7 Sep 2020 (actual)
- Results
- Posted 9 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized to either perform exercises with blood flow restriction therapy or without
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control | No intervention | –Participants in this group performed the exercises without the blood flow restriction therapy cuff |
| Experimental: BFR | Experimental | Device: Blood flow restriction therapyParticipants in this group performed the exercises with the blood flow restriction therapy cuff |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, untrained volunteers
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction therapyThe study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises. | Device | Experimental: BFR |
Primary outcome
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.
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.
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.
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.
1 secondary outcome
Strength Endurance in General Population
Time frame: Baseline and 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12183514Adams GR. Invited Review: Autocrine/paracrine IGF-I and skeletal muscle adaptation. J Appl Physiol (1985). 2002 Sep;93(3):1159-67. doi: 10.1152/japplphysiol.01264.2001.
- Background: PubMed 20581041Burd NA, Holwerda AM, Selby KC, West DW, Staples AW, Cain NE, Cashaback JG, Potvin JR, Baker SK, Phillips SM. Resistance exercise volume affects myofibrillar protein synthesis and anabolic signalling molecule phosphorylation in young men. J Physiol. 2010 Aug 15;588(Pt 16):3119-30. doi: 10.1113/jphysiol.2010.192856. Epub 2010 Jun 25.
- Background: PubMed 19285766Cifrek M, Medved V, Tonkovic S, Ostojic S. Surface EMG based muscle fatigue evaluation in biomechanics. Clin Biomech (Bristol). 2009 May;24(4):327-40. doi: 10.1016/j.clinbiomech.2009.01.010. Epub 2009 Mar 13.
- Background: PubMed 17909396Cook SB, Clark BC, Ploutz-Snyder LL. Effects of exercise load and blood-flow restriction on skeletal muscle function. Med Sci Sports Exerc. 2007 Oct;39(10):1708-13. doi: 10.1249/mss.0b013e31812383d6.
- Background: PubMed 24726484Cools AM, De Wilde L, Van Tongel A, Ceyssens C, Ryckewaert R, Cambier DC. Measuring shoulder external and internal rotation strength and range of motion: comprehensive intra-rater and inter-rater reliability study of several testing protocols. J Shoulder Elbow Surg. 2014 Oct;23(10):1454-61. doi: 10.1016/j.jse.2014.01.006. Epub 2014 Apr 13.
- Background: PubMed 26294055Cools AM, Vanderstukken F, Vereecken F, Duprez M, Heyman K, Goethals N, Johansson F. Eccentric and isometric shoulder rotator cuff strength testing using a hand-held dynamometer: reference values for overhead athletes. Knee Surg Sports Traumatol Arthrosc. 2016 Dec;24(12):3838-3847. doi: 10.1007/s00167-015-3755-9. Epub 2015 Aug 21.
- Background: PubMed 32144492Cornish SM, Bugera EM, Duhamel TA, Peeler JD, Anderson JE. A focused review of myokines as a potential contributor to muscle hypertrophy from resistance-based exercise. Eur J Appl Physiol. 2020 May;120(5):941-959. doi: 10.1007/s00421-020-04337-1. Epub 2020 Mar 6.
- Background: PubMed 26137897Counts BR, Dankel SJ, Barnett BE, Kim D, Mouser JG, Allen KM, Thiebaud RS, Abe T, Bemben MG, Loenneke JP. Influence of relative blood flow restriction pressure on muscle activation and muscle adaptation. Muscle Nerve. 2016 Mar;53(3):438-45. doi: 10.1002/mus.24756. Epub 2015 Dec 29.
- Background: PubMed 26446893Dankel SJ, Jessee MB, Abe T, Loenneke JP. The Effects of Blood Flow Restriction on Upper-Body Musculature Located Distal and Proximal to Applied Pressure. Sports Med. 2016 Jan;46(1):23-33. doi: 10.1007/s40279-015-0407-7.
- Background: PubMed 29022275Figueiredo VC, de Salles BF, Trajano GS. Volume for Muscle Hypertrophy and Health Outcomes: The Most Effective Variable in Resistance Training. Sports Med. 2018 Mar;48(3):499-505. doi: 10.1007/s40279-017-0793-0.
- Background: PubMed 15570149Glowacki SP, Martin SE, Maurer A, Baek W, Green JS, Crouse SF. Effects of resistance, endurance, and concurrent exercise on training outcomes in men. Med Sci Sports Exerc. 2004 Dec;36(12):2119-27. doi: 10.1249/01.mss.0000147629.74832.52.
- Background: PubMed 28121207Hollman JH, Berling TA, Crum EO, Miller KM, Simmons BT, Youdas JW. Do Verbal and Tactile Cueing Selectively Alter Gluteus Maximus and Hamstring Recruitment During a Supine Bridging Exercise in Active Females? A Randomized Controlled Trial. J Sport Rehabil. 2018 Mar 1;27(2):138-143. doi: 10.1123/jsr.2016-0130. Epub 2018 Mar 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick C McCulloch, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction therapy in people with Healthy, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if BFR Changes UE Lean Muscle Mass in the General Population (time frame: Baseline and 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04540367, which also lists 37 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.