- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376906
The Effects of High Intensity Interval Exercise in Obese
December 13, 2017 updated by: Yokiny Silva, Federal University of Paraíba
The Effects of High Intensity Interval Exercise With 1- and 3- Min Recovery Times in Obese
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Obese Subjetcs
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.
|
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.
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).
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Forearm Blood Flow and Vascular Conductance
Time Frame: Up to 2 years
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Up to 2 years
|
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
|
|
Heart rate
Time Frame: Up to 2 years
|
Heart rate was monitored throughout the exercise session using a Polar RS800CX monitor (Polar®, Kempele, Finland).
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Maria do Socorro B Santos, Ph.D., Federal University of Paraíba
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 5, 2016
Primary Completion (Actual)
December 20, 2016
Study Completion (Actual)
January 30, 2017
Study Registration Dates
First Submitted
February 20, 2017
First Submitted That Met QC Criteria
December 13, 2017
First Posted (Actual)
December 19, 2017
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 13, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Interval exercise
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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