Blood Flow RestrictionNCT04977804
Eccentric Resistance Training With Blood Flow Restriction on Muscle Function
A study testing Exercise and Eccentric plus blood-flow restriction in people with Blood Flow Restriction, run by Utah State University at 1 site in United States.
Trial summary
The study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size. 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?
- Exercise and Eccentric plus blood-flow restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2024to 1 Dec 2025
- 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 of age
- currently engaged in some form of resistance training between 1-3 times per week
- must have been training aerobically, but no more than 3 hours a week for the past six months
Who cannot join
- Must not have had any surgery of the lower limbs within the past 1 year period
- Must not have any neuromuscular disorder (e.g., Muscular dystrophy etc.)
- < 76 inches tall (in order to fit on the training machine)
- Maximal strength of < 725 lbs for the eccentric training device
- If any of the subjects are pregnant or plan to be pregnant in the duration of the protocol.
- For those randomized to the BFR group, if any of the subject's thighs are too large for the BFR cuffs (greater than 68 cm).
Trial locations and contacts
1 site in 1 country.
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 study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.
Read the detailed description
Subjects will be randomly assigned to two groups: an eccentric only resistance training group or an eccentric training plus blood flow restriction group. Subjects will train at a moderately low intensity on a multiple-joint eccentric device. Those in the blood flow restriction will wear blood flow restriction cuffs on their upper thighs to reduce blood flow during the brief protocol. The training session will occur twice per week and will last ~5 minutes, including a one minute warm up, a one minute cool down and a three minute workout phase. The training program will last 7 weeks. Testing will be conducted at baseline (following a one session familiarization), 4 weeks and after the end of the 7 week training period. Assessments will focus on muscle strength, function, and morphology (size).
- Conditions
- Blood Flow Restriction
- Being tested
- Exercise, Eccentric plus blood-flow restriction
- Keywords
- resistance training, muscle function, quadriceps, eccentric strength, vertical jump, muscle quality, muscle hypertrophy, eccentric training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
The interventions are a form or exercise, specifically resistance exercise.
Eccentric plus blood-flow restrictionOther
Eccentric plus blood-flow restriction
| Study group | Role | What they receive |
|---|---|---|
| Eccentric only training | Active comparator | This is the experimental control; where this group will be used as the standard active comparison condition. Receives: Other: Exercise |
| Eccentric plus blood-flow restriction | Experimental | This is the experimental condition involving the eccentric resistance training with blood flow restriction. Receives: Other: Eccentric plus blood-flow restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eccentron maximal muscle strength
Eccentric muscle strength will be assessed via Eccentron (BTE Technologies, Inc., USA), an seated isokinetic dynamometer.
Measured: 7 weeks
Local muscle hypertrophy
Muscle size changes of the quadriceps muscle measured an ultrasound device (GE NextGen LOGIQ, Tampa, Florida, USA).
Measured: 7 weeks
Muscle mass
dual energy x-ray absorptiometry device (DEXA) the Hologic Horizon W Dual X-ray absorptiometry (Hologic Canada ULC, Mississauga, ON, Canada) will be used to assess appendicular (lower body) mean mass.
Measured: 7 weeks
Muscle function
Vertical jump height will assess 3 maximal countermovement attempts on a jump mat (Just Jump Technologies, Huntsville, AL, USA) that measures jump height based on flight time.
Measured: 7 weeks
Secondary outcomes (1)
Muscle soreness
local muscle soreness will be assessed throughout the duration of the intervention period using a Wagner force algometer.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start30 Mar 2024 (estimated)
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Why it stopped: A key faculty at our college who was helping with the project left the college.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two group, randomized parallel group design.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
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 J Thompson, PhD, Principal investigator, Utah State Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977804
- Sponsor's protocol ID
- 12042b
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2021
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 7 Dec 2023. 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
- NCT04977804
- Acronym / sponsor ID
- 12042b
- Conditions
- Blood Flow Restriction
- Keywords
- resistance training, muscle function, quadriceps, eccentric strength, vertical jump, muscle quality, muscle hypertrophy, eccentric training
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A key faculty at our college who was helping with the project left the college.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Utah State UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 27 Jul 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 study will determine the effects of adding blood flow restriction to eccentric training to assess whether this increases the improvements of muscle strength and size.
Detailed description
Subjects will be randomly assigned to two groups: an eccentric only resistance training group or an eccentric training plus blood flow restriction group. Subjects will train at a moderately low intensity on a multiple-joint eccentric device. Those in the blood flow restriction will wear blood flow restriction cuffs on their upper thighs to reduce blood flow during the brief protocol. The training session will occur twice per week and will last ~5 minutes, including a one minute warm up, a one minute cool down and a three minute workout phase. The training program will last 7 weeks. Testing will be conducted at baseline (following a one session familiarization), 4 weeks and after the end of the 7 week training period. Assessments will focus on muscle strength, function, and morphology (size).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Two group, randomized parallel group design.
| Arm | Type | Receives |
|---|---|---|
| Eccentric only training | Active comparator | Other: ExerciseThis is the experimental control; where this group will be used as the standard active comparison condition. |
| Eccentric plus blood-flow restriction | Experimental | Other: Eccentric plus blood-flow restrictionThis is the experimental condition involving the eccentric resistance training with blood flow restriction. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-30 years of age
- currently engaged in some form of resistance training between 1-3 times per week
- must have been training aerobically, but no more than 3 hours a week for the past six months
Key exclusion criteria (6 listed)
- Must not have had any surgery of the lower limbs within the past 1 year period
- Must not have any neuromuscular disorder (e.g., Muscular dystrophy etc.)
- < 76 inches tall (in order to fit on the training machine)
- Maximal strength of < 725 lbs for the eccentric training device
- If any of the subjects are pregnant or plan to be pregnant in the duration of the protocol.
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 |
|---|---|---|
| ExerciseThe interventions are a form or exercise, specifically resistance exercise. | Other | Eccentric only training |
| Eccentric plus blood-flow restrictionEccentric plus blood-flow restriction | Other | Eccentric plus blood-flow restriction |
Primary outcome
Eccentron maximal muscle strength
Time frame: 7 weeks
Eccentric muscle strength will be assessed via Eccentron (BTE Technologies, Inc., USA), an seated isokinetic dynamometer.
Local muscle hypertrophy
Time frame: 7 weeks
Muscle size changes of the quadriceps muscle measured an ultrasound device (GE NextGen LOGIQ, Tampa, Florida, USA).
Muscle mass
Time frame: 7 weeks
dual energy x-ray absorptiometry device (DEXA) the Hologic Horizon W Dual X-ray absorptiometry (Hologic Canada ULC, Mississauga, ON, Canada) will be used to assess appendicular (lower body) mean mass.
Muscle function
Time frame: 7 weeks
Vertical jump height will assess 3 maximal countermovement attempts on a jump mat (Just Jump Technologies, Huntsville, AL, USA) that measures jump height based on flight time.
1 secondary outcome
Muscle soreness
Time frame: 7 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
- 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.
Brennan J Thompson, PhD principal investigator
Utah State Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Eccentric plus blood-flow restriction in people with Blood Flow Restriction, run by Utah State University 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 3 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: withdrawn, as of the sponsor's last update on 7 Dec 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
Eccentron maximal muscle strength (time frame: 7 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?
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 Dec 2023.