- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04977804
Eccentric Resistance Training With Blood Flow Restriction on Muscle Function
November 30, 2023 updated by: Brennan Thompson, Utah State University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Logan, Utah, United States, 84322
- Utah State Universtiy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Eccentric only training
This is the experimental control; where this group will be used as the standard active comparison condition.
|
The interventions are a form or exercise, specifically resistance exercise.
|
|
Experimental: Eccentric plus blood-flow restriction
This is the experimental condition involving the eccentric resistance training with blood flow restriction.
|
Eccentric plus blood-flow restriction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eccentron maximal muscle strength
Time Frame: 7 weeks
|
Eccentric muscle strength will be assessed via Eccentron (BTE Technologies, Inc., USA), an seated isokinetic dynamometer.
|
7 weeks
|
|
Local muscle hypertrophy
Time Frame: 7 weeks
|
Muscle size changes of the quadriceps muscle measured an ultrasound device (GE NextGen LOGIQ, Tampa, Florida, USA).
|
7 weeks
|
|
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.
|
7 weeks
|
|
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.
|
7 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle soreness
Time Frame: 7 weeks
|
local muscle soreness will be assessed throughout the duration of the intervention period using a Wagner force algometer.
|
7 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brennan J Thompson, PhD, Utah State Univeristy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 30, 2024
Primary Completion (Estimated)
June 1, 2025
Study Completion (Estimated)
December 1, 2025
Study Registration Dates
First Submitted
July 20, 2021
First Submitted That Met QC Criteria
July 24, 2021
First Posted (Actual)
July 27, 2021
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12042b
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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