- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05344391
BFR Training on a Bike to Augment RC Strength, Leg Strength, and VO2 Peak
Can BFR Training on a Bike Augment RC Strength, Leg Strength, and VO2 Peak
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jason Brumitt, PhD
- Phone Number: 5035542461
- Email: jbrumitt@georgefox.edu
Study Locations
-
-
Oregon
-
Newberg, Oregon, United States, 97132
- Recruiting
- College of Physical Therapy / George Fox University
-
Contact:
- Jason Brumitt, PhD
- Phone Number: 503-554-2461
- Email: jbrumitt@georgefox.edu
-
Newberg, Oregon, United States, 97132
- Recruiting
- George Fox University School of Physical Therapy
-
Contact:
- Jason Brumitt, PhD
- Phone Number: 5035542461
- Email: jbrumitt@georgefox.edu
-
Contact:
- Jason Brumitt, PhD
- Phone Number: 503-554-2461
- Email: jbrumitt@georgefox.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: BFR cycling
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.
|
Cycling with BFR followed by shoulder exercises
|
|
Active Comparator: Cycling without BFR
This group will perform cycling and the same shoulder exercises using the same training parameters; however, BFR will not be applied.
|
Cycling without BFR followed by shoulder exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
VO2peak
Time Frame: 6 weeks
|
Pretest/posttest measures of VO2peak performance on the bicycle using Cosmed Metabolic Cart
|
6 weeks
|
|
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)
|
6 weeks
|
|
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
|
6 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jason Brumitt, PhD, George Fox University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- George Fox College of PT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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