Can BFR Cycling Augment Strength and VO2peakNCT05344391
BFR Training on a Bike to Augment RC Strength, Leg Strength, and VO2 Peak
A study testing BFR cycling and Cycling without BFR in people with Can BFR Cycling Augment Strength and VO2peak, run by George Fox University at 2 sites in United States.
Trial summary
This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Can BFR Cycling Augment Strength and VO2peak
- What is being tested?
- BFR cycling and Cycling without BFR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Apr 2022to 30 Jan 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Inclusion Criteria: healthy adults (18 yrs of age and older) -
Exclusion Criteria: no current musculoskeletal symptoms/injuries; no prior lower extremity or shoulder/upper extremity surgery (dominant) during the prior year; no contraindications to BFR training
-
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
College of Physical Therapy / George Fox University
Newberg, Oregon, 97132
JASON BRUMITT, PhD, 503-554-2461, jbrumitt@georgefox.edu
- Recruiting
George Fox University School of Physical Therapy
Newberg, Oregon, 97132
Jason Brumitt, PhD, 503-554-2461, jbrumitt@georgefox.edu
Jason Brumitt, PhD, 5035542461, jbrumitt@georgefox.edu
About this study
Official title: Can BFR Training on a Bike Augment RC Strength, Leg Strength, and VO2 Peak
This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength (hand held dynamometer testing for supraspinatus and external rotators) and greater gains in VO2 peak.
Read the detailed description
This study will randomize healthy adult subjects to one of two groups: a BFR biking group that performs 10 min of cycling at 40% heart rate reserve (HRR) with bilateral occlusion applied to the proximal thighs (80% LOP) or to a non-biking BFR group perform 10 min of cycling at 40% HRR. After each cycling session subjects will perform 3x15 of the scaption exercise and 3x15 sidelying external rotation with their dominant upper extremity. They will initially start training the shoulder at 30% of 1RM (estimated from an equation formula) for the first 2 weeks followed by increasing training load by 1lbs each exercise every 2 weeks. The training program will last 6 weeks (3x week for 6 weeks, total of 18 sessions).
Pretest and posttests will include: VO2 peak testing on a cycle using Cosmed metabolic cart, hand held dynamometry to measure strength of the supraspinatus and external rotators of the shoulder using traditional manual muscle test positions, and on a separate day 10RM testing on a leg press for the dominant lower extremity.
- Being tested
- BFR cycling, Cycling without BFR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFR cyclingOther
Cycling with BFR followed by shoulder exercises
Cycling without BFROther
Cycling without BFR followed by shoulder exercises
| Study group | Role | What they receive |
|---|---|---|
| BFR cycling | Experimental | This group will perform cycling with BFR applied bilaterally at 80% LOP for 10 min and cycling at 40% HRR. Next they will perform 3x15 of the scaption and sidelying external rotation exercises. These will initially be performed at 30% 1RM; every 2 weeks load increased by 1lbs. Receives: Other: BFR cycling |
| Cycling without BFR | Active comparator | This group will perform cycling and the same shoulder exercises using the same training parameters; however, BFR will not be applied. Receives: Other: Cycling without BFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2peak
Pretest/posttest measures of VO2peak performance on the bicycle using Cosmed Metabolic Cart
Measured: 6 weeks
Shoulder Strength
Using a Hand Held Dynamometer; shoulder strength will be measured pretest/posttest for teh supraspinatus and the shoulder external rotators (dominant UE)
Measured: 6 weeks
10 RM unilateral leg press for the dominant lower extremity
Test 10 RM strength on the leg press for the dominant LE/ pretest/posttest
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start10 Apr 2022
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Can BFR Cycling Augment Strength and VO2peakStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Fox University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Brumitt, George Fox University
- Investigators
- JASON BRUMITT, PhD, Principal investigator, George Fox University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05344391
- Sponsor's protocol ID
- George Fox College of PT
- Status last verified
- Apr 2022
- First submitted
- 19 Apr 2022
- Last updated
- 25 Apr 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 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can BFR Training on a Bike Augment RC Strength, Leg Strength, and VO2 Peak
- ClinicalTrials.gov ID
- NCT05344391
- Acronym / sponsor ID
- George Fox College of PT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- George Fox UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 25 Apr 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.
This study will investigate if subjects who bike at 40% of heart rate reserve (HRR) with blood flow restriction (BFR) applied to bilateral thighs for 10 minutes (at 80% limb occlusion pressure) will experience greater gains in 10 rep max for dominant lower extremity leg press, greater gains in rotator cuff strength (hand held dynamometer testing for supraspinatus and external rotators) and greater gains in VO2 peak.
Detailed description
This study will randomize healthy adult subjects to one of two groups: a BFR biking group that performs 10 min of cycling at 40% heart rate reserve (HRR) with bilateral occlusion applied to the proximal thighs (80% LOP) or to a non-biking BFR group perform 10 min of cycling at 40% HRR. After each cycling session subjects will perform 3x15 of the scaption exercise and 3x15 sidelying external rotation with their dominant upper extremity. They will initially start training the shoulder at 30% of 1RM (estimated from an equation formula) for the first 2 weeks followed by increasing training load by 1lbs each exercise every 2 weeks. The training program will last 6 weeks (3x week for 6 weeks, total of 18 sessions).
Pretest and posttests will include: VO2 peak testing on a cycle using Cosmed metabolic cart, hand held dynamometry to measure strength of the supraspinatus and external rotators of the shoulder using traditional manual muscle test positions, and on a separate day 10RM testing on a leg press for the dominant lower extremity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BFR cycling | Experimental | Other: BFR cyclingThis group will perform cycling with BFR applied bilaterally at 80% LOP for 10 min and cycling at 40% HRR. Next they will perform 3x15 of the scaption and sidelying external rotation exercises. These will initially be performed at 30% 1RM; every 2 weeks load increased by 1lbs. |
| Cycling without BFR | Active comparator | Other: Cycling without BFRThis group will perform cycling and the same shoulder exercises using the same training parameters; however, BFR will not be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| BFR cyclingCycling with BFR followed by shoulder exercises | Other | BFR cycling |
| Cycling without BFRCycling without BFR followed by shoulder exercises | Other | Cycling without BFR |
Primary outcome
VO2peak
Time frame: 6 weeks
Pretest/posttest measures of VO2peak performance on the bicycle using Cosmed Metabolic Cart
Shoulder Strength
Time frame: 6 weeks
Using a Hand Held Dynamometer; shoulder strength will be measured pretest/posttest for teh supraspinatus and the shoulder external rotators (dominant UE)
10 RM unilateral leg press for the dominant lower extremity
Time frame: 6 weeks
Test 10 RM strength on the leg press for the dominant LE/ pretest/posttest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No
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.
JASON BRUMITT, PhD principal investigator
George Fox University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BFR cycling and Cycling without BFR in people with Can BFR Cycling Augment Strength and VO2peak, run by George Fox University at 2 sites 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?
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 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JASON BRUMITT, PhD (5035542461, jbrumitt@georgefox.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2peak (time frame: 6 weeks). The study lists 3 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 25 Apr 2022.