NCT03376906

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable obesity

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

December 19, 2017

Completed
Last Updated

December 19, 2017

Status Verified

December 1, 2017

Enrollment Period

7 months

First QC Date

February 20, 2017

Last Update Submit

December 13, 2017

Conditions

Keywords

Obesityaerobic exerciseinterval exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Blood pressure

    Up to 2 years

  • Heart rate

    Up to 2 years

Study Arms (1)

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.

Procedure: HIIE 1Procedure: HIIE 3Procedure: Control

Interventions

HIIE 1PROCEDURE

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.

Obese Subjetcs
HIIE 3PROCEDURE

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).

Obese Subjetcs
ControlPROCEDURE

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.

Obese Subjetcs

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Maria do Socorro B Santos, Ph.D.

    Federal University of Paraíba

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist

Study Record Dates

First Submitted

February 20, 2017

First Posted

December 19, 2017

Study Start

June 5, 2016

Primary Completion

December 20, 2016

Study Completion

January 30, 2017

Last Updated

December 19, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share