Blood Flow RestrictionNCT05606744
Effects of Blood Flow Restriction During Eccentric Resistance Exercise
A study testing Eccentric exercise / Eccentric exercise with blood flow restriction in people with Blood Flow Restriction, run by Utah State University.
Trial summary
The purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities. 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
- What is being tested?
- Eccentric exercise / Eccentric exercise with blood flow restriction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 1 Mar 2024
- 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
- 18 - 30 years old
- strength train lower body 1-3 times per week
Who cannot join
- lower body surgery or injury in the last 12 months
- have any neuromuscular disease
- height >76 inches tall
- height <54 inches tall
- eccentric strength greater than 725 pounds
- pregnant or plan to be pregnant in the duration of the protocol
Show all 9Show fewer
- don't do resistance exercise at least once per week
- perform intense cardio or strength training >4 days per week
- Present with any other significant comorbid conditions that would impair the ability to participate in the exercise-based testing
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Blood Flow Restriction During Multiple-joint Eccentric Resistance Training on Muscle Morphology and Function of the Lower Body
The purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities.
- Conditions
- Blood Flow Restriction
- Being tested
- Eccentric exercise / Eccentric exercise with blood flow restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exercise / Eccentric exercise with blood flow restrictionDevice
Individuals will be randomized to receive eccentric exercise only, or eccentric exercise with blood flow restriction.
| Study group | Role | What they receive |
|---|---|---|
| Eccentric exercise | Active comparator | Only multi-joint eccentric exercise Receives: Device: Eccentric exercise / Eccentric exercise with blood flow restriction |
| Eccentric training with blood flow restriction | Experimental | Multi-joint eccentric exercise with blood flow restriction Receives: Device: Eccentric exercise / Eccentric exercise with blood flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale (soreness)
soreness
Measured: Baseline (pretest)
visual analog scale (soreness)
soreness
Measured: immediately post exercise
visual analog scale (soreness)
soreness
Measured: 24 hours post exercise
visual analog scale (soreness)
soreness
Measured: 48 hours post exercise
visual analog scale (soreness)
soreness
Measured: 72 hours post exercise
force algometer (soreness)
soreness
Measured: Baseline (pretest)
force algometer (soreness)
soreness
Measured: immediately post exercise
force algometer (soreness)
soreness
Measured: 24 hours post exercise
force algometer (soreness)
soreness
Measured: 48 hours post exercise
force algometer (soreness)
soreness
Measured: 72 hours post exercise
Secondary outcomes (10)
Eccentric muscle strength
muscle strength will be assessed on the Eccentron.
Measured: Baseline (pretest)
Eccentric muscle strength
muscle strength will be assessed on the Eccentron.
Measured: immediately post exercise
Eccentric muscle strength
muscle strength will be assessed on the Eccentron.
Measured: 24 hours post exercise
Eccentric muscle strength
muscle strength will be assessed on the Eccentron.
Measured: 48 hours post exercise
Eccentric muscle strength
muscle strength will be assessed on the Eccentron.
Measured: 72 hours post exercise
Single-leg hop
3 single-leg hops per limb
Measured: Baseline (pretest)
Single-leg hop
3 single-leg hops per limb
Measured: immediately post exercise
Single-leg hop
3 single-leg hops per limb
Measured: 24 hours post exercise
Single-leg hop
3 single-leg hops per limb
Measured: 48 hours post exercise
Single-leg hop
3 single-leg hops per limb
Measured: 72 hours post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2022
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Flow RestrictionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Individuals will be randomly assigned to a BFR or non BFR exercise condition. The subjects will perform a single, 3-5 minute bout of eccentric exercise on the Eccentron device either with BFR (with restriction cuffs on the thigh per the procedures below) or without the BFR.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Utah State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brennan Thompson, Utah State University
- Investigators
- Brennan Thompson, PhD, Principal investigator, Utah State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05606744
- Sponsor's protocol ID
- 12042a
- Status last verified
- Nov 2022
- First submitted
- 13 Oct 2022
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction During Multiple-joint Eccentric Resistance Training on Muscle Morphology and Function of the Lower Body
- ClinicalTrials.gov ID
- NCT05606744
- Acronym / sponsor ID
- 12042a
- Conditions
- Blood Flow Restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Nov 2022 (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 purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Individuals will be randomly assigned to a BFR or non BFR exercise condition. The subjects will perform a single, 3-5 minute bout of eccentric exercise on the Eccentron device either with BFR (with restriction cuffs on the thigh per the procedures below) or without the BFR.
| Arm | Type | Receives |
|---|---|---|
| Eccentric exercise | Active comparator | Device: Eccentric exercise / Eccentric exercise with blood flow restrictionOnly multi-joint eccentric exercise |
| Eccentric training with blood flow restriction | Experimental | Device: Eccentric exercise / Eccentric exercise with blood flow restrictionMulti-joint eccentric exercise with blood flow restriction |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 - 30 years old
- strength train lower body 1-3 times per week
Key exclusion criteria (9 listed)
- lower body surgery or injury in the last 12 months
- have any neuromuscular disease
- height >76 inches tall
- height <54 inches tall
- eccentric strength greater than 725 pounds
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 |
|---|---|---|
| Eccentric exercise / Eccentric exercise with blood flow restrictionIndividuals will be randomized to receive eccentric exercise only, or eccentric exercise with blood flow restriction. | Device | Eccentric exercise, Eccentric training with blood flow restriction |
Primary outcome
visual analog scale (soreness)
Time frame: Baseline (pretest)
soreness
visual analog scale (soreness)
Time frame: immediately post exercise
soreness
visual analog scale (soreness)
Time frame: 24 hours post exercise
soreness
visual analog scale (soreness)
Time frame: 48 hours post exercise
soreness
visual analog scale (soreness)
Time frame: 72 hours post exercise
soreness
force algometer (soreness)
Time frame: Baseline (pretest)
soreness
force algometer (soreness)
Time frame: immediately post exercise
soreness
force algometer (soreness)
Time frame: 24 hours post exercise
soreness
force algometer (soreness)
Time frame: 48 hours post exercise
soreness
force algometer (soreness)
Time frame: 72 hours post exercise
soreness
10 secondary outcomes
Eccentric muscle strength
Time frame: Baseline (pretest)
Eccentric muscle strength
Time frame: immediately post exercise
Eccentric muscle strength
Time frame: 24 hours post exercise
Eccentric muscle strength
Time frame: 48 hours post exercise
Eccentric muscle strength
Time frame: 72 hours post exercise
Single-leg hop
Time frame: Baseline (pretest)
Single-leg hop
Time frame: immediately post exercise
Single-leg hop
Time frame: 24 hours post exercise
Single-leg hop
Time frame: 48 hours post exercise
Single-leg hop
Time frame: 72 hours post exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
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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.
Brennan Thompson, PhD principal investigator
Utah State University
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise / Eccentric exercise with blood flow restriction in people with Blood Flow Restriction, run by Utah State University.
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 2 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Brennan J Thompson, PhD (435-797-5785, brennan.thompson@usu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analog scale (soreness) (time frame: Baseline (pretest)). The study lists 10 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 7 Nov 2022.