ObesityNCT03376906
The Effects of High Intensity Interval Exercise in Obese
A study testing HIIE 1 and HIIE 3 in people with Obesity and Endothelial Dysfunction, run by Federal University of Paraíba.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity, Endothelial Dysfunction
- What is being tested?
- HIIE 1 and HIIE 3
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 5 Jun 2016to 30 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
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.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Endothelial Dysfunction
- Being tested
- HIIE 1, HIIE 3, Control
- Keywords
- Obesity, aerobic exercise, interval exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIE 1Procedure or surgery
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 3Procedure or surgery
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).
ControlProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Obese Subjetcs | Experimental | 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. Receives: Procedure: HIIE 1; Procedure: HIIE 3; Procedure: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (2)
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).
Measured: Up to 2 years
Heart rate
Heart rate was monitored throughout the exercise session using a Polar RS800CX monitor (Polar®, Kempele, Finland).
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2017
- Study start5 Jun 2016
- Primary completion20 Dec 2016
- Study completion30 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yokiny Silva, Federal University of Paraíba
- Investigators
- Maria do Socorro B Santos, Ph.D., Study director, Federal University of Paraíba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376906
- Sponsor's protocol ID
- Interval exercise
- Status last verified
- Dec 2017
- First submitted
- 20 Feb 2017
- Last updated
- 19 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of High Intensity Interval Exercise With 1- and 3- Min Recovery Times in Obese
- ClinicalTrials.gov ID
- NCT03376906
- Acronym / sponsor ID
- Interval exercise
- Conditions
- Obesity, Endothelial Dysfunction
- Keywords
- Obesity, aerobic exercise, interval exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- 5 Jun 2016 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 30 Jan 2017 (actual)
- First posted
- 19 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| Obese Subjetcs | Experimental | Procedure: HIIE 1, Procedure: HIIE 3, Procedure: ControlThe 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIE 1In 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. | Procedure or surgery | Obese Subjetcs |
| HIIE 3In 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). | Procedure or surgery | Obese Subjetcs |
| ControlIn 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. | Procedure or surgery | Obese Subjetcs |
Primary outcome
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.
2 secondary outcomes
Blood pressure
Time frame: Up to 2 years
Heart rate
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria do Socorro B Santos, Ph.D. study director
Federal University of Paraíba
Questions about this trial
What is this clinical trial studying?
A study testing HIIE 1 and HIIE 3 in people with Obesity and Endothelial Dysfunction, run by Federal University of Paraíba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm Blood Flow and Vascular Conductance (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2017.