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

NCT ID: NCT06276673

Last Updated: 2024-02-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-13
• Study Completion Date: 2024-12-10

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.

Detailed 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.

Conditions

Blood Vessel Disease; Muscle Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

single chamber blood flow restriction cuff

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.

Group Type: EXPERIMENTAL

Delfi

Intervention Type: 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.

Multiple chamber blood flow restriction cuff

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.

Group Type: EXPERIMENTAL

Delfi

Intervention Type: 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.

No BFR cuff

No cuff will be worn during the training session.

Group Type: PLACEBO_COMPARATOR

Delfi

Intervention Type: 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.

Interventions

Delfi

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.

Intervention Type: DEVICE

Other Intervention Names

B-Strong

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Salisbury University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Werner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Salisbury University

Salisbury, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39610655 (View on PubMed)

Other Identifiers

301

Identifier Type: -

Identifier Source: org_study_id