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Microvascular and Metabolic Effects of High-intensity Interval Exercise Training (HIIT-FAST)

Primary Purpose

Obesity, Overweight, Physical Activity

Status
Withdrawn
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
High-intensity interval exercise training in the fed state
Continous exercise training in the fed state
High-intensity interval exercise training in the fasting state
Continous exercise training in the fasting state
Sponsored by
National Institute of Cardiology, Laranjeiras, Brazil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Obesity, Microcirculation, Endothelial function, Laser speckle imaging, Capillary density

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • National Institute of Cardiology, Ministry of Health, Brazil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HIIT only

CT+FAST

CT only

HIIT+FAST

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Capillary density
Number of spontaneously perfused skin capillaries per mm2

Secondary Outcome Measures

Microvascular reactivity assessed by laser speckle contrast imaging
Skin microvascular flow in arbitrary perfusion units

Full Information

First Posted
July 27, 2017
Last Updated
March 11, 2019
Sponsor
National Institute of Cardiology, Laranjeiras, Brazil
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1. Study Identification

Unique Protocol Identification Number
NCT03236285
Brief Title
Microvascular and Metabolic Effects of High-intensity Interval Exercise Training
Acronym
HIIT-FAST
Official Title
Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Facilities for the exercise training program were not available for the study.
Study Start Date
February 20, 2018 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiology, Laranjeiras, Brazil

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits. Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight, Physical Activity
Keywords
Obesity, Microcirculation, Endothelial function, Laser speckle imaging, Capillary density

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIIT only
Arm Type
Experimental
Arm Description
Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state
Arm Title
CT+FAST
Arm Type
Experimental
Arm Description
Volunteers will be submitted to continous training (CT) performed in the fasting state
Arm Title
CT only
Arm Type
Experimental
Arm Description
Volunteers will be submitted to continous training (CT) performed in fed state.
Arm Title
HIIT+FAST
Arm Type
Experimental
Arm Description
Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval exercise training in the fed state
Intervention Description
High-intensity interval exercise training in the fed state
Intervention Type
Behavioral
Intervention Name(s)
Continous exercise training in the fed state
Intervention Description
Continous exercise training in the fed state
Intervention Type
Behavioral
Intervention Name(s)
High-intensity interval exercise training in the fasting state
Intervention Description
High-intensity interval exercise training in the fasting state
Intervention Type
Behavioral
Intervention Name(s)
Continous exercise training in the fasting state
Intervention Description
Continous exercise training in the fasting state
Primary Outcome Measure Information:
Title
Capillary density
Description
Number of spontaneously perfused skin capillaries per mm2
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Microvascular reactivity assessed by laser speckle contrast imaging
Description
Skin microvascular flow in arbitrary perfusion units
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EDUARDO V TIBIRICA, MD, PhD
Organizational Affiliation
National Innstitute of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institute of Cardiology, Ministry of Health, Brazil
City
Rio de Janeiro
ZIP/Postal Code
22240-006
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
29705753
Citation
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.
Results Reference
derived

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Microvascular and Metabolic Effects of High-intensity Interval Exercise Training

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