Healthy
Conditions
Keywords
Blood Flow Restriction (BFR), Healthy Volunteers
Brief summary
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects.
Detailed description
The purpose of this research is to determine the effects of low-load blood flow restriction (BFR) training compared to conventional strengthening using dynamic force plate and isometric force frame analyses in healthy subjects. The primary research procedures are: Subjects will be randomized into either BFR or conventional strengthening groups. BFR and conventional strengthening programs will be implemented. Force plate and force frame data will be collected at baseline, 4, 6, 8, 12, and 16 weeks. Subject Population. The study will enroll 18 healthy volunteers. The study includes 6 visits. The total study duration for each subject is 16 weeks. The device the investigators intend to use is Class I and in a class of devices that is exempt from the FDA requirement for premarket notification/approval (exempt from 510K or PMA), which would not be subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act
Interventions
DEVICEBFR
Exercises may involve warm up on a stationary bike for 5 minutes, application of a BFR cuff (a cuff that often uses air to inflate around a limb) on the selected extremity, and exercise sets (e.g. banded squats, step ups, Romanian dead lifts). We will record metrics on an iPad. Testing will be done with ForceDecks and ForceFrames (system for measuring muscle strength and imbalance).
OTHERStanard strengthening program.
The exercise program will be completed 3 times per week Participants will warm up on a stationary bike for 5 minutes The program will consist of the following exercises using a 30,15,15,15 rep scheme: Banded squats Step ups (8 inch) Romanian dead lifts (RDL)
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers without history of knee pathology requiring physical therapy or surgery * Individuals between 18 and 40 years old
Exclusion criteria
* History of venous thromboembolism or other hematologic disorder Pregnant * Coronary artery disease, peripheral arterial disease, or hypertension (\> 140/90 mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the change in Force plate measures from baseline to 16 weeks | Measured at 4,6,8,12 and 16 weeks. | Displacement |
| The change in Force plate measures from baseline to 16 weeks | Measured at 4, 6, 8, 12, and 16 weeks. | Force (N) |
| the changes in Force plate measures from baseline to 16 weeks | Measured at 4,6,8,12 and 16 weeks. | Relative strength index (RSI) |
| the changes in Force Frame measures from baseline to 16 weeks | Measured at 4,6,8,12 and 16 weeks. | Force (N) |
| the changes in Force Frame measure from baseline to 16 weeks | Measured at 4,6,8,12 and 16 weeks. | Velocity M/sec |
Countries
United States
Outcome results
None listed