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

NCT06276673 | Active Not Recruiting FDA Device

• 1 other identifier: 301
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Vessel Disease; Muscle Edema

Outcome Measures

Primary Outcomes (2)

• Arterial Stiffness

  A measurement of vascular health.

  Prior to and 10-minutes after the exercise intervention

• Muscle Morphology

  A measurement of vastus lateralis cross sectional area

  Prior to and immediately after the exercise intervention

Study Arms (3)

single chamber blood flow restriction cuff

EXPERIMENTAL

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.

Device: Delfi

Multiple chamber blood flow restriction cuff

EXPERIMENTAL

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.

Device: Delfi

No BFR cuff

PLACEBO COMPARATOR

No cuff will be worn during the training session.

Device: Delfi

Interventions

Delfi DEVICE

Cuffs will be worn throughout the entire training session. Training session consist of lower intensity wall squats. Four sets of wall squats will be performed to failure. Arterial stiffness and muscle morphological assessments will be conducted before and after the exercise.

Also known as: B-Strong

Multiple chamber blood flow restriction cuff; No BFR cuff; single chamber blood flow restriction cuff

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• BP\>140/90 mmHg
• BMI\>40 kg/m2
• Diabetes
• Familial hypercholesterolemia
• 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.
• Women must not be pregnant, plan to become pregnant during the study, or be nursing
• Active renal or liver disease
• All medications and supplements that influence dependent variables\*
• Recent surgery \< 2 months
• Alcohol abuse
• Sleep apnea
• Claustrophobia

Sponsors & Collaborators

• Salisbury University: lead

Study Sites (1)

Salisbury University

Salisbury, Maryland, 21801, United States

Location

Related Publications (1)

• Rolnick N, de Queiros VS, Moghaddam M, Peikon E, Taylor S, Watson S, Ruffhead C, Zupnik S, Werner T. Cardiovascular, perceptual, and performance responses to single- vs. multi-chambered blood flow restriction cuffs. Front Sports Act Living. 2024 Nov 14;6:1469356. doi: 10.3389/fspor.2024.1469356. eCollection 2024.

  PMID: 39610655 DERIVED

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Unable to blind due to differences in cuff size and appearance.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will undergo three treatment sessions (control (no BFR), SC BFR, and MC BFR) in a randomized order separated by one week.

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 26, 2024
• Study Start: February 13, 2024
• Primary Completion: November 10, 2024
• Study Completion: December 10, 2024
• Last Updated: February 26, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be shared after study is published for five years.

Locations

US (1)