NCT03236285

Brief Summary

The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 20, 2018

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

3.6 years

First QC Date

July 27, 2017

Last Update Submit

March 11, 2019

Conditions

ObesityOverweightPhysical Activity

Keywords

ObesityMicrocirculationEndothelial functionLaser speckle imagingCapillary density

Outcome Measures

Primary Outcomes (1)

  • Capillary density

    Number of spontaneously perfused skin capillaries per mm2

    6 months

Secondary Outcomes (1)

  • Microvascular reactivity assessed by laser speckle contrast imaging

    6 months

Study Arms (4)

HIIT only

EXPERIMENTAL

Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state

Behavioral: High-intensity interval exercise training in the fed state

CT+FAST

EXPERIMENTAL

Volunteers will be submitted to continous training (CT) performed in the fasting state

Behavioral: Continous exercise training in the fasting state

CT only

EXPERIMENTAL

Volunteers will be submitted to continous training (CT) performed in fed state.

Behavioral: Continous exercise training in the fed state

HIIT+FAST

EXPERIMENTAL

Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.

Behavioral: High-intensity interval exercise training in the fasting state

Interventions

High-intensity interval exercise training in the fed stateBEHAVIORAL

High-intensity interval exercise training in the fed state

HIIT only
Continous exercise training in the fed stateBEHAVIORAL

Continous exercise training in the fed state

CT only
High-intensity interval exercise training in the fasting stateBEHAVIORAL

High-intensity interval exercise training in the fasting state

HIIT+FAST
Continous exercise training in the fasting stateBEHAVIORAL

Continous exercise training in the fasting state

CT+FAST

Eligibility Criteria

Age30 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female gender
  • Age≥ 30 years and ≤50 years
  • Premenopausal status
  • Body mass index \>25 kg/m2
  • At least one of the following:
  • waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol \<50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl

You may not qualify if:

  • Any cardiovascular disease, including systemic hypertension
  • Diabetes mellitus
  • Chronic pulmonary disease
  • Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
  • Orthopedic or neurologic conditions that might impair exercise training
  • Pregnancy or breastfeeding
  • Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
  • Current engagement in any exercise training protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Cardiology, Ministry of Health, Brazil

Rio de Janeiro, 22240-006, Brazil

Location

Related Publications (1)

  • De Lorenzo A, Van Bavel D, de Moraes R, Tibirica EV. High-intensity interval training or continuous training, combined or not with fasting, in obese or overweight women with cardiometabolic risk factors: study protocol for a randomised clinical trial. BMJ Open. 2018 Apr 28;8(4):e019304. doi: 10.1136/bmjopen-2017-019304.

    PMID: 29705753DERIVED

MeSH Terms

Conditions

ObesityOverweightMotor Activity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • EDUARDO V TIBIRICA, MD, PhD

    National Innstitute of Cardiology

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 27, 2017

First Posted

August 1, 2017

Study Start

February 20, 2018

Primary Completion

October 1, 2021

Study Completion

October 1, 2021

Last Updated

March 13, 2019

Record last verified: 2019-03

Locations

BR(1)