Muscle MassNCT03055260
Low Intensity Blood Flow Restriction Training Study
A study testing Blood flow restriction cuff in people with Muscle Mass, run by University of Minnesota at 1 site in United States.
Trial summary
The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both… Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Mass
- What is being tested?
- Blood flow restriction cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2017to 31 Dec 2018
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-49
Who cannot join
- Pregnant
- Hypertensive
- Recent back or lower extremity injury
- History of blood clotting
- Varicose veins
- Adults lacking the capacity to consent for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
Fairview Health Services
Minneapolis, Minnesota, 55414
About this study
Official title: Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy
The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. After baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested and compared to the initial measurements.
Read the detailed description
Session 1 - baseline testing
- 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements of both right and left quadriceps muscle using ultrasound technology.
- After day 1 testing; randomly allocate subjects to either control group or experimental group
Sessions 2-13 - 6 weeks of exercise protocol, 2x/per week
Both the experimental and control groups will complete the same protocol for the entirety of the study:
- 5- minute warm up
- Using a single-leg press exercise machine: Subjects complete the testing protocol with either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb.
- Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by ~30-90 seconds.
- Right and left legs will be alternating, but only one leg will have the occlusion cuff
Session 14 - Re-test
- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound
- Conditions
- Muscle Mass
- Being tested
- Blood flow restriction cuff, Blood Flow restriction Cuff-Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction cuffDevice
The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
Blood Flow restriction Cuff-PlaceboDevice
The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
| Study group | Role | What they receive |
|---|---|---|
| Blood flow restriction cuff | Experimental | This group will receive an active cuff that partially restricts blood flow to the experimental limb. Receives: Device: Blood flow restriction cuff |
| Blood Flow restriction Cuff-Placebo | Placebo comparator | This group will wear a placebo cuff, of which will not restrict blood flow at all. Receives: Device: Blood Flow restriction Cuff-Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Repetition Maximum
One repetition maximum on the single leg press. Isometric quadriceps extension strength.
Measured: 6 weeks
Secondary outcomes (1)
Quadriceps Muscle Thickness
Difference between groups in the measurement of the muscle thickness of the quadriceps muscle via ultrasound.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2017
- Study start23 May 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
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 (2)Papers the sponsor has linked to this study.
- Other trials for Muscle MassStudies 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
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Fairview Health Services
- Responsible party
- Sponsor
- Investigators
- Jon Schoenecker, DPT, Principal investigator, Fairview Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03055260
- Sponsor's protocol ID
- 1612M02121
- Status last verified
- Feb 2020
- First submitted
- 8 Feb 2017
- Last updated
- 28 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.
Publications
Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
PubMed 21922259Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.
PubMed 26463594
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Intensity Blood Flow Restriction Training on Lower Extremity Strength and Hypertrophy
- ClinicalTrials.gov ID
- NCT03055260
- Acronym / sponsor ID
- 1612M02121
- Conditions
- Muscle Mass
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Fairview Health Services
- Study start
- 23 May 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 16 Feb 2017 (actual)
- Results
- Posted 28 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The particpant will complete baseline testing by measuring subjects' quadriceps muscle thickness (cm) via ultrasound technology, as well as have them complete a one repetition maximum (1RM) test on the leg press machine and an isometric knee extension using a dynamometer - strength measures will be calculated for both right and left legs. After baseline testing, subjects will complete 6 weeks of the testing protocol that will consist of leg press exercises at 30% of their 1RM. Subjects will be randomized to either wear a cuff that partially restricts blood flow to the limb (Study Group), or to wear a cuff that does not restrict blood flow (Control Group). Exercises will be completed 2x/week and will take approximately 10 total minutes (5 for warm up, 5 for testing protocol) per session. After 6 weeks, muscle thickness, leg press 1RM, and quadriceps extension strength will be re-tested and compared to the initial measurements.
Detailed description
Session 1 - baseline testing
- 5-minute warm-up; 1RM calculation for both right and left legs using a supine leg press machine; isometric quadriceps strength measurement using a dynamometer; muscle thickness measurements of both right and left quadriceps muscle using ultrasound technology.
- After day 1 testing; randomly allocate subjects to either control group or experimental group
Sessions 2-13 - 6 weeks of exercise protocol, 2x/per week
Both the experimental and control groups will complete the same protocol for the entirety of the study:
- 5- minute warm up
- Using a single-leg press exercise machine: Subjects complete the testing protocol with either partial blood flow restriction (cuff inflated to 100-250 mmhg depending on size of person) or no blood flow restriction (placebo inflation) on right limb.
- Protocol: 30 repetitions - 15 repetitions - 15 repetitions - 15 repetitions with each set separated by ~30-90 seconds.
- Right and left legs will be alternating, but only one leg will have the occlusion cuff
Session 14 - Re-test
- Re-check 1RM, isometric quad strength, as well as muscle thickness of quadriceps with ultrasound
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction cuff | Experimental | Device: Blood flow restriction cuffThis group will receive an active cuff that partially restricts blood flow to the experimental limb. |
| Blood Flow restriction Cuff-Placebo | Placebo comparator | Device: Blood Flow restriction Cuff-PlaceboThis group will wear a placebo cuff, of which will not restrict blood flow at all. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 18-49
Key exclusion criteria (6 listed)
- Pregnant
- Hypertensive
- Recent back or lower extremity injury
- History of blood clotting
- Varicose veins
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 cuffThe intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb. | Device | Blood flow restriction cuff |
| Blood Flow restriction Cuff-PlaceboThe intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb. | Device | Blood Flow restriction Cuff-Placebo |
Primary outcome
One Repetition Maximum
Time frame: 6 weeks
One repetition maximum on the single leg press. Isometric quadriceps extension strength.
1 secondary outcome
Quadriceps Muscle Thickness
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21922259Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
- Background: PubMed 26463594Slysz J, Stultz J, Burr JF. The efficacy of blood flow restricted exercise: A systematic review & meta-analysis. J Sci Med Sport. 2016 Aug;19(8):669-75. doi: 10.1016/j.jsams.2015.09.005. Epub 2015 Sep 28.
- Individual participant dataSharing planned: Yes. Research coordinator/statistician will have access to blinded, individual data for the purpose of record keeping and analysis.
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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.
Jon Schoenecker, DPT principal investigator
Fairview Health Services
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 cuff in people with Muscle Mass, run by University of Minnesota 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 6 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 28 Feb 2020. 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. Some participants in this study may receive a placebo. 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 28 Feb 2020). 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?
One Repetition Maximum (time frame: 6 weeks). 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 NCT03055260, which also lists 2 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 28 Feb 2020.