The Influences of Single Chamber vs. Multi-chamber Blood Flow Restriction Cuffs

Salisbury University

Status: Active, not recruiting

Conditions: Blood Vessel Disease; Muscle Edema

Treatments: Device: Delfi

Study type: Interventional

Funder types: Other

Identifiers

NCT06276673

301

Details and patient eligibility

About

The purpose of this study is to investigate the use of single (SC) and multi-chamber (MC) blood flow restriction (BFR) cuff exercise on indices of arterial stiffness, muscle morphology, and participant perception.

Full description

Thirty adults aged 18-40 years old will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week. A familiarization session will also occur one week before starting the treatment period. Each subject will undergo a series of tests including anthropometry, ultrasonography of the carotid artery, applanation tonometry, ultrasonography of the vastus lateralis, blood pressure acquisition, body composition, and maximal strength assessments (1RM). The exercise trial will consist of sets of dumbbell wall squats performed to failure with a 2-seconds concentric and 2-seconds eccentric cadence, at 20% of their 1RM using 60% of the supine limb occlusion pressure (LOP) with 1-minute rest intervals. Assessments will be performed immediately before and after the exercise bout during each treatment session. Two-way ANOVAs will be used to examine the main effects of treatment and treatment-order interaction on pulse wave velocity, muscle cross-sectional area, and perceptual response.

Enrollment: 35 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Physically active (> 1,000 MET/min/wk) for at least six months.
2. Weight stable for previous 6 months (+/-2.5 kg)
3. Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion criteria

1. BP>140/90 mmHg
2. BMI>40 kg/m2
3. Diabetes
4. Familial hypercholesterolemia
5. Past or current history of CHD, stroke or major CVD events. Respiratory diseases (not including asthma), endocrine or metabolic, neurological, or hematological disorders that would compromise the study or the health of the subject.
6. Women must not be pregnant, plan to become pregnant during the study, or be nursing
7. Active renal or liver disease
8. All medications and supplements that influence dependent variables*
9. Recent surgery < 2 months
10. Alcohol abuse
11. Sleep apnea
12. Claustrophobia

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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35 participants in 3 patient groups, including a placebo group

single chamber blood flow restriction cuff

Experimental group

Description:

Single Chamber BFR (Delfi, Vancouver, Canada) training devices will be used for exercise and testing sessions (see attachment). Cuffs will be placed around the right and left proximal thigh. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed.

Treatment:

Device: Delfi

Multiple chamber blood flow restriction cuff

Experimental group

Description:

Multiple chamber BFR (B-Strong, Park City, UT) training devices will be used for exercise and testing sessions (see attachment). Cuffs will be placed around the right and left proximal thigh. The LOP will be set at 60% immediately before exercise and will be applied during the entire exercise set (approximately 30-60 seconds in duration) in accordance with manufacturer specifications. The cuffs will maintain pressure during training and rest periods. The LOP will be decreased to 0% immediately after the set is completed.

Treatment:

Device: Delfi

No BFR cuff

Placebo Comparator group

Description:

No cuff will be worn during the training session.

Treatment:

Device: Delfi