Severe Muscle AtrophyBFRTNCT04357184
BFRT for Severe Lower Extremity Muscle Atrophy
A study testing Blood flow restriction training in people with Severe Muscle Atrophy and Muscle Weakness, run by Cincinnati Sportsmedicine Research and Education Foundation at 1 site in United States.
Trial summary
Muscle weakness or atrophy is a common condition following acute and chronic musculoskeletal injuries. Strength training is an imperative component in clinical rehabilitation of musculoskeletal injuries. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Severe Muscle Atrophy, Muscle Weakness
- What is being tested?
- Blood flow restriction training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2020to 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with > 20% deficit in isometric quadriceps and/or hamstrings strength
- Patients willing to complete at least 9 BFRT training sessions
- Patients willing to provide informed consent (or parental consent)
Who cannot join
- Pregnancy
- History of varicose veins
- History of blood clots or active blood clot
- Taking oral contraceptives
- History of heart attack
- Unstable cardiac disease
Show all 9Show fewer
- Taking heart failure medication
- Uncontrolled hypertension (> 140/90)
- Uncontrolled tachycardia (> 100 bpm)
Trial locations and contacts
1 site in 1 country.
United States1 site
Cincinnati Sportsmedicine and Orthopaedic Center
Cincinnati, Ohio, 45242
About this study
Official title: Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy
Muscle weakness or atrophy is a common condition following acute and chronic musculoskeletal injuries. Strength training is an imperative component in clinical rehabilitation of musculoskeletal injuries. Heavy exercise loads (approximately 70% of one repetition maximum) is necessary to elicit muscle hypertrophy and strength gains. However, patients with severe muscle atrophy are frequently unable to tolerate these loads due to pain. Blood flow resistance training with low resistance loads may be used to safely develop muscle strength.
Read the detailed description
Blood flow restriction training (BFRT) is a safe type of low intensity resistance exercise that has demonstrated enhanced muscle growth, muscle strength, oxygen delivery and utilization (VO2Max). With BFRT, lighter loads can be used to build muscle while sparing the joints from heavy loading and without overly fatiguing the central nervous system.
The objectives of BFRT are 1) to increase the effectiveness of physical therapy, 2) safely increase muscle mass, reduce arterial stiffness, increase bone density, increase Vo2Max, improve carotid arterial compliance and enhance response of the autonomic nervous system, 3) improve muscle endurance in 1/3 the time, improve strength and hypertrophy after surgery, improve muscle recruitment and increase anabolic growth signaling.
- Conditions
- Severe Muscle Atrophy, Muscle Weakness
- Being tested
- Blood flow restriction training
- Medical subject headings
- Muscular Atrophy, Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction trainingOther
BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum
| Study group | Role | What they receive |
|---|---|---|
| BFRT with 4 exercises and low resistance loads | Experimental | Blood flow resistance training will be performed with a standard blood pressure cuff that is placed and inflated by a clinician. The patient will perform 4 exercises with low resistance loads that will produce a muscle burn to enhance promotion of strength. Training will be supervised in the clinic. The cuff is deflated between exercises. Receives: Other: Blood flow restriction training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric quadriceps and hamstrings muscle strength
Isometric knee flexor and extensor strength will be measured with an isokinetic dynamometer before training and after each series of 9 training sessions
Measured: Strength will be measured for each patient before training begins and then after 9 training sessions have been completed, for the duration of the study, up to 100 weeks
Secondary outcomes (1)
Patient rating
Patients will rate the intensity of muscle burn produced during training and overall satisfaction with the final result
Measured: The intensity of muscle burn will be determined during each training session. The overall satisfaction will be determined after the last training session for each patient, for the duration of the study, up to 100 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start14 Apr 2020
- 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 Severe Muscle AtrophyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sue Barber-Westin, Cincinnati Sportsmedicine Research and Education Foundation
- Investigators
- Frank R Noyes, MD, Principal investigator, Cincinnati Sportsmedicine Research and Education Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357184
- Sponsor's protocol ID
- BFRT17-37
- Acronym
- BFRT
- Status last verified
- Feb 2022
- First submitted
- 14 Apr 2020
- Last updated
- 16 Feb 2022
- 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 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Restriction Training for Severe Lower Extremity Muscle Atrophy
- ClinicalTrials.gov ID
- NCT04357184
- Acronym / sponsor ID
- BFRT / BFRT17-37
- Conditions
- Severe Muscle Atrophy, Muscle Weakness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cincinnati Sportsmedicine Research and Education FoundationUniversity, hospital or other
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 22 Apr 2020 (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.
Muscle weakness or atrophy is a common condition following acute and chronic musculoskeletal injuries. Strength training is an imperative component in clinical rehabilitation of musculoskeletal injuries. Heavy exercise loads (approximately 70% of one repetition maximum) is necessary to elicit muscle hypertrophy and strength gains. However, patients with severe muscle atrophy are frequently unable to tolerate these loads due to pain. Blood flow resistance training with low resistance loads may be used to safely develop muscle strength.
Detailed description
Blood flow restriction training (BFRT) is a safe type of low intensity resistance exercise that has demonstrated enhanced muscle growth, muscle strength, oxygen delivery and utilization (VO2Max). With BFRT, lighter loads can be used to build muscle while sparing the joints from heavy loading and without overly fatiguing the central nervous system.
The objectives of BFRT are 1) to increase the effectiveness of physical therapy, 2) safely increase muscle mass, reduce arterial stiffness, increase bone density, increase Vo2Max, improve carotid arterial compliance and enhance response of the autonomic nervous system, 3) improve muscle endurance in 1/3 the time, improve strength and hypertrophy after surgery, improve muscle recruitment and increase anabolic growth signaling.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BFRT with 4 exercises and low resistance loads | Experimental | Other: Blood flow restriction trainingBlood flow resistance training will be performed with a standard blood pressure cuff that is placed and inflated by a clinician. The patient will perform 4 exercises with low resistance loads that will produce a muscle burn to enhance promotion of strength. Training will be supervised in the clinic. The cuff is deflated between exercises. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with > 20% deficit in isometric quadriceps and/or hamstrings strength
- Patients willing to complete at least 9 BFRT training sessions
- Patients willing to provide informed consent (or parental consent)
Key exclusion criteria (9 listed)
- Pregnancy
- History of varicose veins
- History of blood clots or active blood clot
- Taking oral contraceptives
- History of heart attack
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 trainingBFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum | Other | BFRT with 4 exercises and low resistance loads |
Primary outcome
Isometric quadriceps and hamstrings muscle strength
Time frame: Strength will be measured for each patient before training begins and then after 9 training sessions have been completed, for the duration of the study, up to 100 weeks
Isometric knee flexor and extensor strength will be measured with an isokinetic dynamometer before training and after each series of 9 training sessions
1 secondary outcome
Patient rating
Time frame: The intensity of muscle burn will be determined during each training session. The overall satisfaction will be determined after the last training session for each patient, for the duration of the study, up to 100 weeks.
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 16 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Severe Muscle Atrophy
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
COMMAND Early Feasibility Study: Implantable BCI to Control a Digital Device for People With Paralysis
Neurologic Disorder, Paralysis
RecruitingObservational study
Multimodal Nutritional and Sarcopenia Assessment for Risk Stratification in Lung Cancer Surgery
Lung Cancer (Non-Small Cell), Sarcopenia
Active, not recruitingObservational study
Early Check: Expanded Screening in Newborns
Spinal Muscular Atrophy, Fragile X Syndrome
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.
Frank R Noyes, MD principal investigator
Cincinnati Sportsmedicine Research and Education Foundation
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 training in people with Severe Muscle Atrophy and Muscle Weakness, run by Cincinnati Sportsmedicine Research and Education Foundation 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 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: finished, as of the sponsor's last update on 16 Feb 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?
Isometric quadriceps and hamstrings muscle strength (time frame: Strength will be measured for each patient before training begins and then after 9 training sessions have been completed, for the duration of the study, up to 100 weeks). 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 16 Feb 2022.