Back to resultsThe Effects of High Intensity Interval Exercise in Obese
Primary Purpose
Obesity, Endothelial Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
HIIE 1
HIIE 3
Control
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Obesity, aerobic exercise, interval exercise
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Obese Subjetcs
Arm Description
The subjects were welcomed for a visit to the Laboratory of Studies of Physical Training Applied to Health, where they performed an evaluation of body composition, maximal ergospirometric exercise test, and three experimental sessions (HIIE 1, HIIE 3 and Control) in a random order, which were performed with a 96 h interval between them.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Heart rate
Heart rate was monitored throughout the exercise session using a Polar RS800CX monitor (Polar®, Kempele, Finland).
Full Information
NCT ID
NCT03376906
First Posted
February 20, 2017
Last Updated
December 13, 2017
Sponsor
Federal University of Paraíba
1. Study Identification
Unique Protocol Identification Number
NCT03376906
Brief Title
The Effects of High Intensity Interval Exercise in Obese
Official Title
The Effects of High Intensity Interval Exercise With 1- and 3- Min Recovery Times in Obese
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
June 5, 2016 (Actual)
Primary Completion Date
December 20, 2016 (Actual)
Study Completion Date
January 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Endothelial Dysfunction
Keywords
Obesity, aerobic exercise, interval exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The subjects were welcomed for a visit to the Laboratory of Studies of Physical Training Applied to Health, where they performed an evaluation of body composition, maximal ergospirometric exercise test, and three experimental sessions in a random order, which were performed with a 96 h interval between them. In order to obtain the experimental session order, the researcher asked each subject to pick out random numbers that were inside an opaque envelope generated at www.randomizer.org.
Before the experimental sessions, subjects were instructed to maintain a regular sleep pattern, and to not consume alcohol, caffeine or xanthines (coffee, chocolate, soft drinks and tea), take medication or exercise in the 24 h prior to the experimental protocol sessions. In addition, they were duly instructed to fill out the food registry (food recall).
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Obese Subjetcs
Arm Type
Experimental
Arm Description
The subjects were welcomed for a visit to the Laboratory of Studies of Physical Training Applied to Health, where they performed an evaluation of body composition, maximal ergospirometric exercise test, and three experimental sessions (HIIE 1, HIIE 3 and Control) in a random order, which were performed with a 96 h interval between them.
Intervention Type
Procedure
Intervention Name(s)
HIIE 1
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
HIIE 3
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Forearm Blood Flow and Vascular Conductance
Description
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.
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Blood pressure
Description
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).
Time Frame
Up to 2 years
Title
Heart rate
Description
Heart rate was monitored throughout the exercise session using a Polar RS800CX monitor (Polar®, Kempele, Finland).
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria do Socorro B Santos, Ph.D.
Organizational Affiliation
Federal University of Paraíba
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of High Intensity Interval Exercise in Obese
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