Clinical trial NCT05868304: Lower Extremity BFR-randomized Controlled Trial Healthy Volunteers
Official title: Dynamic and Isometric Strength Analyses of Lower Extremity Blood Flow Restriction Training: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Blood Flow Restriction (BFR)
Healthy Volunteers
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: The change in Force plate measures from baseline to 16 weeks
timeFrame: Measured at 4, 6, 8, 12, and 16 weeks.
measure: The change in Force plate measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: The change in Force plate measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: the changes in Force plate measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: the change in Force plate measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: the changes in Force Frame measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: the changes in Force Frame measures from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
measure: the changes in Force Frame measure from baseline to 16 weeks
timeFrame: Measured at 4,6,8,12 and 16 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedar Sinai Kerlan jobe orthopedic institute
state: California
Study officials:
References: