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

Healthy Lifestyle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05719090
• Other study ID #: #7
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: January 2023
• Source: Salisbury University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Healthy Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United States	Salisbury University	Salisbury	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Salisbury University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beta-Stiffness Index	A measurement that compares carotid SBP and DBP with carotid systolic and diastole diameters.	Baseline and 10 minutes after exercise on day 1
Primary	Carotid-femoral pulse wave velocity	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.	Baseline and 10 minutes after exercise on day 1