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Cardiometabolic HIIT-RT Study

Primary Purpose

Metabolic Diseases, Overweight, Motor Activity

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
High Intensity Interval
Resistance training
Plus: High Intensity Interval + Resistance Training
Usual clinical care
Sponsored by
Universidad Santo Tomas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Diseases

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL.
  • Written informed consent.
  • Interested in improving health and fitness.

Exclusion Criteria:

  • Systemic infections.
  • Weight loss or gain of >10% of body weight in the past 6 months for any reason.
  • Currently taking medication that suppresses or stimulates appetite.
  • Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
  • Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
  • Asthma.
  • Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
  • Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
  • Any active use of illegal or illicit drugs.
  • Current exerciser (>30 min organized exercise per week).
  • Indication of unsuitability of current health for exercise protocol (PARQ).
  • Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.

Sites / Locations

  • Robinson Ramírez Vélez Ph.D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

High Intensity Interval

Resistance training

Plus: High Intensity Interval + Resistance Training

Usual clinical care

Arm Description

Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training.

Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max.

Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week.

This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.

Outcomes

Primary Outcome Measures

Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer.

Secondary Outcome Measures

Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry
Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program
Body Weight
Body Mass Index
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Blood Pressure
Change from Baseline in peak uptake of volume of oxygen
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Change from Baseline in muscular fitness
Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
Change from Baseline in Flexibility using the sit and reach test
Change from Baseline in LDL Cholesterol
Change from Baseline in HDL Cholesterol
Change from Baseline in Triglycerides
Change from Baseline in Glucose
Change from Baseline in Hemoglobin A1c
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Change from Baseline in Heart rate variability
HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
24-hour dietary recall
Dietary data will be collected from participants on 24h of their study enrollment. Prior to administration of the 24HR, each subject received two-dimensional food models with depiction of foods and serving sizes in order to assist in reporting portion sizes of food intake.
Aortic pulse wave velocity (PWVao) and augmentation index (AIx)
PWVao and AIx will be measured with oscillometric method using the occlusion technique.

Full Information

First Posted
March 8, 2016
Last Updated
October 10, 2018
Sponsor
Universidad Santo Tomas
Collaborators
Universidad del Rosario, Universidad Manuela Beltrán
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1. Study Identification

Unique Protocol Identification Number
NCT02715063
Brief Title
Cardiometabolic HIIT-RT Study
Official Title
High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): Study Protocol for a Factorial Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Santo Tomas
Collaborators
Universidad del Rosario, Universidad Manuela Beltrán

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health
Detailed Description
The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Diseases, Overweight, Motor Activity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Intensity Interval
Arm Type
Experimental
Arm Description
Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training.
Arm Title
Resistance training
Arm Type
Active Comparator
Arm Description
Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max.
Arm Title
Plus: High Intensity Interval + Resistance Training
Arm Type
Active Comparator
Arm Description
Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week.
Arm Title
Usual clinical care
Arm Type
Placebo Comparator
Arm Description
This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Interval
Intervention Description
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Intervention Type
Behavioral
Intervention Name(s)
Resistance training
Intervention Description
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Intervention Type
Behavioral
Intervention Name(s)
Plus: High Intensity Interval + Resistance Training
Intervention Description
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
Intervention Type
Other
Intervention Name(s)
Usual clinical care
Intervention Description
Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
Primary Outcome Measure Information:
Title
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
Description
FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer.
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Secondary Outcome Measure Information:
Title
Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry
Description
Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Body Weight
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Body Mass Index
Description
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Blood Pressure
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in peak uptake of volume of oxygen
Description
It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in muscular fitness
Description
Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Flexibility using the sit and reach test
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in LDL Cholesterol
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in HDL Cholesterol
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Triglycerides
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Glucose
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Hemoglobin A1c
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Change from Baseline in Heart rate variability
Description
HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
24-hour dietary recall
Description
Dietary data will be collected from participants on 24h of their study enrollment. Prior to administration of the 24HR, each subject received two-dimensional food models with depiction of foods and serving sizes in order to assist in reporting portion sizes of food intake.
Time Frame
Baseline and 12 weeks immediately after the interventions ends
Title
Aortic pulse wave velocity (PWVao) and augmentation index (AIx)
Description
PWVao and AIx will be measured with oscillometric method using the occlusion technique.
Time Frame
Baseline and 12 weeks immediately after the interventions ends

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL. Written informed consent. Interested in improving health and fitness. Exclusion Criteria: Systemic infections. Weight loss or gain of >10% of body weight in the past 6 months for any reason. Currently taking medication that suppresses or stimulates appetite. Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment. Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy). Asthma. Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications. Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months). Any active use of illegal or illicit drugs. Current exerciser (>30 min organized exercise per week). Indication of unsuitability of current health for exercise protocol (PARQ). Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robinson Ramírez Vélez, Ph.D
Organizational Affiliation
Universidad del Rosario
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robinson Ramírez Vélez Ph.D
City
Bogotá
State/Province
Cundinamarca
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28934175
Citation
Ramirez-Velez R, Correa-Bautista JE, Gonzalez-Ruiz K, Tordecilla-Sanders A, Garcia-Hermoso A, Schmidt-RioValle J, Gonzalez-Jimenez E. The Role of Body Adiposity Index in Determining Body Fat Percentage in Colombian Adults with Overweight or Obesity. Int J Environ Res Public Health. 2017 Sep 21;14(10):1093. doi: 10.3390/ijerph14101093.
Results Reference
derived
PubMed Identifier
27342073
Citation
Ramirez-Velez R, Hernandez A, Castro K, Tordecilla-Sanders A, Gonzalez-Ruiz K, Correa-Bautista JE, Izquierdo M, Garcia-Hermoso A. High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): study protocol for a randomised controlled trial. Trials. 2016 Jun 24;17(1):298. doi: 10.1186/s13063-016-1422-1.
Results Reference
derived

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Cardiometabolic HIIT-RT Study

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