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Completed

NCT Number: NCT05719090

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salisbury University

Salisbury, Maryland, 21801, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-40 years old
  • Physically active (> 6 months of consistent exercise training)
  • Weight stable for previous 6 months (+/-2.5 kg)
  • Female subjects only- reported regular menstrual cycles for the last 2 years

Exclusion criteria

  • 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

Treatment and study plan

Delfi Personal Tourniquet Systems

Device

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

Primary outcomes

  1. Beta-Stiffness Index

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Salisbury University

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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