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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376906
Other study ID # Interval exercise
Secondary ID
Status Completed
Phase N/A
First received February 20, 2017
Last updated December 13, 2017
Start date June 5, 2016
Est. completion date January 30, 2017

Study information

Verified date December 2017
Source Federal University of Paraíba
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Obesity is a complex and multifactorial disease. Excess weight is related to endothelial dysfunction, inflammation and oxidative stress which increases the risk for cardiovascular diseases. High-intensity interval exercise can release vasodilatory substances and promote increased muscle blood flow.


Description:

This study evaluated the effects of the recovery interval duration (1 vs. 3 min) in high intensity interval exercise (HIIE) on the hemodinamics responses in obese individuals. Twelve obese subjects (27 ± 3.8 yrs) were evaluated, who underwent three experimental sessions with a randomized crossover design: one control session (no exercise) and two HIIE sessions with the same workload (10 x 1min @92%VO2max / 1[HIIE 1] or 3[HIIE 3] min @0%). Forearm blood flow (FBF) and blood pressure (BP) were measured before and after the experimental sessions. Heart rate and relative perceived exertion were assessed during HIIE.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date January 30, 2017
Est. primary completion date December 20, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion criteria for the study were obesity and the conditions of being insufficiently active, non-smokers and without previous history of: heart disease, obstructive or restrictive pulmonary diseases, and orthopedic morbidities. Fifty-one (51) subjects were evaluated for eligibility, and 39 subjects were excluded after an initial interview since they did not meet the aforementioned inclusion criteria.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
HIIE 1
In the HIIE 1 session, all the subjects performed 10 stimuli of 1 min at high intensity (92% of VO2Max) with passive recovery (without exercise) of 1 min.
HIIE 3
In the HIIE 3 session, the subjects performed the same stimulus of the HIIE1, but with passive recovery of 3 min. Both protocols started with a warm-up of 5 min at 50% of the VO2Peak performed on a T2-100 GE Healthcare® treadmill (Lynn Medical, Wixon, Michigan, USA).
Control
In the control session, participants remained seated for 30 min. During HIIE 1 and 2, HR and RPE were assessed immediately after stimulus intervals (ten measurements at each HIIE). In all sessions, the subjects remained in supine position to obtain hemodynamic measurements which were obtained before and at 10 min, 30 min and 60 min after the HIIE and control sessions.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Federal University of Paraíba

Outcome

Type Measure Description Time frame Safety issue
Primary Forearm Blood Flow and Vascular Conductance Forearm muscular blood flow was obtained through the venous occlusion plethysmography technique (19). For this, a silicon tube filled with mercury and connected to a low-pressure transducer was placed around the forearm, 5 cm away from the humeral-radial joint, connected to a plethysmograph (Hokanson® / EC6 plethysmograph, Bellevue, Washington, USA). A cuff was placed around the wrist and another at the upper arm, and the wrist cuff was inflated to a supra-systolic level every 1 min before measurements start. The arm cuff was inflated above the venous pressure at 10 s intervals for a period of 7 to 8 s. The increase in tension in the silastic tube reflects the increase in the volume of the forearm, which indicates vasodilation. The muscle flow wave signal was collected and stored on the WINDAQ DI 200 DATAQ program. Vascular conductance in the forearm was calculated by the blood flow ratio in the forearm (mL.min-1.100mL-1) and mean arterial pressure (mmHg) multiplied by 100. Up to 2 years
Secondary Blood pressure Blood pressure values were obtained in a non-invasive manner, using an oscillometric method (Dixtal®, DX 2020; Manaus, Amazonas, Brazil). The occlusive cuff was positioned on the left ankle of the subject and was inflated minute by minute, providing systolic (SBP), diastolic (DBP) and mean (MBP) blood pressure values. For electrocardiogram (ECG) acquisition, three electrodes were placed on the thorax of the subjects in the bipolar position and DII derivation. After pre-amplification of the ECG signal, a conversion from analog to digital was performed, and later stored in a computer and processed by the WINDAQ DI-200 program (WinDaq DI-200, Akron, Ohio). Up to 2 years
Secondary Heart rate Heart rate was monitored throughout the exercise session using a Polar RS800CX monitor (Polar®, Kempele, Finland). Up to 2 years
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