Blood Flow Restriction and Low-Intensity Resistance TrainingNCT04938947
Resistance Training and Blood Flow Restriction
A study testing Blood Flow Restriction Cuffs, Low-Intensity Resistance Training and High-Intensity Resistance Training in people with Blood Flow Restriction and Low-Intensity Resistance Training, run by University of Kansas at 1 site in United States.
Trial summary
The primary purposes of the proposed study is 1) To examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction and 2) To examine changes in motor… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Flow Restriction and Low-Intensity Resistance Training
- What is being tested?
- Blood Flow Restriction Cuffs, Low-Intensity Resistance Training and High-Intensity Resistance Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Sep 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- -
Who cannot join
- Participants must not have participated in resistance training more than 5 times in the 6 months preceding the study.
- Participants must be healthy and free of any cardiovascular, metabolic or musculoskeletal conditions that may affect the results of the investigation.
- Participants must not have a history of severe hip, knee and/or ankle injuries, or any other pathological conditions that impair their motor control.
- Participants must not have any pre-existing cardiovascular conditions that involve blood flow/blood clotting.
- Participants who are currently taking blood thinners or any medications regulating blood pressures or heart rate will not be eligible to participate in the study.
- Female participants who are pregnant at the start of or who are planning to become pregnant during the resistance training intervention will not be eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Resistance Training With Blood Flow Restriction on Motor Unit Hypertrophy in the Vastus Lateralis
The primary purposes of the proposed study is 1) To examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction and 2) To examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction.
Read the detailed description
Specific Aims and Hypotheses:
Specific Aim 1: To examine the changes of type I and II (different types of muscle fibers) muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 1: Type I and II fiber cross-sectional area will increase following low-intensity resistance training with blood flow restriction, however, only cross-sectional area of type II fibers will increase post high-intensity resistance training.
Specific Aim 2: To examine changes in the size of the motor units that are active during low and high intensity contractions in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 2: The motor units that are active during low and high intensity contractions will increase in size from low-intensity resistance training with blood flow restriction, but only the motor units that are active during high intensity contractions will increase in size from high-intensity resistance training.
Specific Aim 3: To examine changes in whole muscle cross-sectional area as measured via ultrasound pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 3: Whole muscle cross-sectional area will increase to similar degrees from both high-intensity resistance training and low-intensity resistance training with blood flow restriction.
- Being tested
- Blood Flow Restriction Cuffs, Low-Intensity Resistance Training, High-Intensity Resistance Training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Flow Restriction CuffsDevice
Also called Blood Flow Occlusion Cuffs
This intervention consists of inflatable cuffs that are designed to partially occlude veinous blood return from the lower extremities during resistance training.
Low-Intensity Resistance TrainingOther
This intervention consists of performing low-intensity bilateral (both legs at the same time) leg extensions using 30% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.
High-Intensity Resistance TrainingOther
This intervention consists of performing high-intensity bilateral (both legs at the same time) leg extensions using 80% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Resistance Training Group | Experimental | Participants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each resistance training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure (likely 8-12 repetitions) using 80% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2). Receives: Other: High-Intensity Resistance Training |
| Low-Intensity Resistance Training with Blood Flow Restriction Group | Experimental | Participants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure using 30% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2). Participants in this group will perform all leg extensions with blood flow restriction cuffs applied to the proximal thigh of both legs. The pressure that the cuffs are inflated to will be calculated based on estimates of each subject's arterial occlusion pressure from their thigh circumference. Once the target pressure is reached, the cuffs will not be deflated until after the final set of the training session. Receives: Device: Blood Flow Restriction Cuffs; Other: Low-Intensity Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine changes in muscle fiber cross-sectional area
A primary purpose of the study is to examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction
Measured: July 2021-May 2022
Determine changes in motor unit size
Another primary purpose of the study is to examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction
Measured: July 2021- May 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start22 Sep 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow Restriction and Low-Intensity Resistance TrainingStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanner Reece, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938947
- Sponsor's protocol ID
- STUDY00147374
- Status last verified
- Oct 2022
- First submitted
- 22 Jun 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Resistance Training With Blood Flow Restriction on Motor Unit Hypertrophy in the Vastus Lateralis
- ClinicalTrials.gov ID
- NCT04938947
- Acronym / sponsor ID
- STUDY00147374
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- 22 Sep 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purposes of the proposed study is 1) To examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction and 2) To examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction.
Detailed description
Specific Aims and Hypotheses:
Specific Aim 1: To examine the changes of type I and II (different types of muscle fibers) muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 1: Type I and II fiber cross-sectional area will increase following low-intensity resistance training with blood flow restriction, however, only cross-sectional area of type II fibers will increase post high-intensity resistance training.
Specific Aim 2: To examine changes in the size of the motor units that are active during low and high intensity contractions in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 2: The motor units that are active during low and high intensity contractions will increase in size from low-intensity resistance training with blood flow restriction, but only the motor units that are active during high intensity contractions will increase in size from high-intensity resistance training.
Specific Aim 3: To examine changes in whole muscle cross-sectional area as measured via ultrasound pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction. Hypothesis 3: Whole muscle cross-sectional area will increase to similar degrees from both high-intensity resistance training and low-intensity resistance training with blood flow restriction.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Resistance Training Group | Experimental | Other: High-Intensity Resistance TrainingParticipants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each resistance training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure (likely 8-12 repetitions) using 80% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2). |
| Low-Intensity Resistance Training with Blood Flow Restriction Group | Experimental | Device: Blood Flow Restriction Cuffs, Other: Low-Intensity Resistance TrainingParticipants in this group will complete 3 resistance training sessions per week for 6 weeks (18 sessions total). During each training session, participants will perform 3 sets of bilateral leg-extensions (performed with both legs) to volitional failure using 30% of their 1-repetition maximum (the most weight they are able to perform 1 complete repetition with, but not 2). Participants in this group will perform all leg extensions with blood flow restriction cuffs applied to the proximal thigh of both legs. The pressure that the cuffs are inflated to will be calculated based on estimates of each subject's arterial occlusion pressure from their thigh circumference. Once the target pressure is reached, the cuffs will not be deflated until after the final set of the training session. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (6 listed)
- Participants must not have participated in resistance training more than 5 times in the 6 months preceding the study.
- Participants must be healthy and free of any cardiovascular, metabolic or musculoskeletal conditions that may affect the results of the investigation.
- Participants must not have a history of severe hip, knee and/or ankle injuries, or any other pathological conditions that impair their motor control.
- Participants must not have any pre-existing cardiovascular conditions that involve blood flow/blood clotting.
- Participants who are currently taking blood thinners or any medications regulating blood pressures or heart rate will not be eligible to participate in the study.
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 CuffsAlso: Blood Flow Occlusion CuffsThis intervention consists of inflatable cuffs that are designed to partially occlude veinous blood return from the lower extremities during resistance training. | Device | Low-Intensity Resistance Training with Blood Flow Restriction Group |
| Low-Intensity Resistance TrainingThis intervention consists of performing low-intensity bilateral (both legs at the same time) leg extensions using 30% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure. | Other | Low-Intensity Resistance Training with Blood Flow Restriction Group |
| High-Intensity Resistance TrainingThis intervention consists of performing high-intensity bilateral (both legs at the same time) leg extensions using 80% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure. | Other | High-Intensity Resistance Training Group |
Primary outcome
Determine changes in muscle fiber cross-sectional area
Time frame: July 2021-May 2022
A primary purpose of the study is to examine the changes of muscle fiber cross-sectional areas in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction
Determine changes in motor unit size
Time frame: July 2021- May 2022
Another primary purpose of the study is to examine changes in motor unit size (a non-invasive measure of muscle fiber size) in the leg extensor muscles (vastus lateralis) pre- to post- 6 weeks of high-intensity resistance training and low-intensity resistance training with blood flow restriction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cuffs, Low-Intensity Resistance Training and High-Intensity Resistance Training in people with Blood Flow Restriction and Low-Intensity Resistance Training, run by University of Kansas 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 1 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 changes in muscle fiber cross-sectional area (time frame: July 2021-May 2022). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Nov 2022.