Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Exercise on Indices of Arterial Stiffness

Sponsor
Salisbury University (Other)
Overall Status
Completed
CT.gov ID
NCT05719090
Collaborator
(none)
20
1
3
3.3
6

Study Details

Study Description

Brief Summary

To investigate the acute effects of autoregulated (AR) and non-autoregulated (NAR) BFR exercise on indices of arterial stiffness. AR BFR training devices adjust pressure in the cuff ensuring similar pressure throughout the range of motion when the muscles are contracted (dilatated) and relaxed. NAR BFR training devices do not adjust pressure in the cuff throughout the range of motion when the muscles are contracted and relaxed which cause greater pressures at different points in the range of motion. METHODS: Following a randomized AR or NAR familiarization training session, 20 adults (23±5 years; 7 female) participated in 3 randomized treatment-order sessions with AR-BFR, NAR-BFR, and no- BFR separated by 1-week washout periods. Participants performed 4 sets of dumbbell wall squats to failure using 20% of 1 repetition maximum (1-RM) at 2-second concentric/eccentric cadence. Training limb occlusion pressure (LOP) was set at 60% of supine LOP for both the AT and NAR sessions. Testing before and immediately following the training session included ultrasonography of the carotid artery, applanation tonometry, and blood pressure acquisition. Two-way ANOVAs were used to examine the effects of treatment and the treatment-order interaction on pulse wave velocity (PWV), beta-stiffness index (β-stiff), and arterial compliance (AC). RESULTS: There were no baseline differences in CF- (carotid-femoral) PWV, CR- (carotid-radial) PWV, β-stiff, and AC (all p > 0.05). CF-PWV increased in the NAR-BFR (mean difference = 0.57±1.12 m/s, p = 0.02) and no-BFR (mean difference = 0.63±1.42 m/s, p = 0.03) groups following the exercise session. CR-PWV increased in the no-BFR (mean difference = 0.82±1.5 m/s, p = 0.03) group. And there was an interaction effect in CFPWV between AR-BFR and NAR-BFR (mean difference = 0.70±1.6 m/s, p = 0.03). CONCLUSION: These findings show acute AR-BFR training does not influence indices of arterial stiffness while acute NAR-BRF training increases central stiffness.

Condition or Disease Intervention/Treatment Phase
  • Device: Delfi Personal Tourniquet Systems
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Acute Effects of Autoregulated and Non-autoregulated Blood Flow Restrictive Exercise on Indices of Arterial Stiffness
Actual Study Start Date :
Oct 1, 2022
Actual Primary Completion Date :
Dec 10, 2022
Actual Study Completion Date :
Jan 10, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Autoregulated blood flow restriction

Autoregulated BFR expands as the muscle progresses into the stretch-shortening cycle.

Device: Delfi Personal Tourniquet Systems
Measure within & between differences in acute vascular compliance from pre- to post-training with autoregulated BFR, nonautoregulated BFR and no BFR conditions.

Active Comparator: Non-autoregulated blood flow restriction

Non-autoregulated BFR does not expand as the muscle progresses into the stretch-shortening cycle.

Device: Delfi Personal Tourniquet Systems
Measure within & between differences in acute vascular compliance from pre- to post-training with autoregulated BFR, nonautoregulated BFR and no BFR conditions.

Active Comparator: No blood flow restriction

This group serves as the control group for this study

Device: Delfi Personal Tourniquet Systems
Measure within & between differences in acute vascular compliance from pre- to post-training with autoregulated BFR, nonautoregulated BFR and no BFR conditions.

Outcome Measures

Primary Outcome Measures

  1. Beta-Stiffness Index [Baseline and 10 minutes after exercise on day 1]

    A measurement that compares carotid SBP and DBP with carotid systolic and diastole diameters.

  2. Carotid-femoral pulse wave velocity [Baseline and 10 minutes after exercise on day 1]

    A measurement that records the time difference between the foot of the systolic wave form as it arrives at the carotid and femoral arterial sites. It is measured with an arterial tonometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Age 18-40 years old

  2. Physically active (> 6 months of consistent exercise training)

  3. Weight stable for previous 6 months (+/-2.5 kg)

  4. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Salisbury University Salisbury Maryland United States 21801

Sponsors and Collaborators

  • Salisbury University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Salisbury University
ClinicalTrials.gov Identifier:
NCT05719090
Other Study ID Numbers:
  • #7
First Posted:
Feb 8, 2023
Last Update Posted:
Feb 8, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes

Study Results

No Results Posted as of Feb 8, 2023