Cardiometabolic HIIT-RT Study

Sponsor
Universidad Santo Tomas (Other)
Overall Status
Completed
CT.gov ID
NCT02715063
Collaborator
Universidad del Rosario (Other), Universidad Manuela Beltrán (Other)
60
1
4
12
5

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: High Intensity Interval
  • Behavioral: Resistance training
  • Behavioral: Plus: High Intensity Interval + Resistance Training
  • Other: Usual clinical care
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Factorial Assignment
Masking:
Single (Investigator)
Primary Purpose:
Prevention
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 Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: High Intensity Interval

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.

Behavioral: High Intensity Interval
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Active Comparator: Resistance 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.

Behavioral: Resistance training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Active Comparator: Plus: High Intensity Interval + Resistance Training

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.

Behavioral: Plus: High Intensity Interval + Resistance Training
Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.

Placebo Comparator: Usual clinical care

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.

Other: Usual clinical care
Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD) [Baseline and 12 weeks immediately after the interventions ends]

    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

  1. Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry [Baseline and 12 weeks immediately after the interventions ends]

    Changes in abdominal and total adiposity (DEXA), lean tissue mass and bone mass (DEXA) the 12 weeks intervention program

  2. Body Weight [Baseline and 12 weeks immediately after the interventions ends]

  3. Body Mass Index [Baseline and 12 weeks immediately after the interventions ends]

    BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.

  4. Blood Pressure [Baseline and 12 weeks immediately after the interventions ends]

  5. Change from Baseline in peak uptake of volume of oxygen [Baseline and 12 weeks immediately after the interventions ends]

    It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol

  6. Change from Baseline in muscular fitness [Baseline and 12 weeks immediately after the interventions ends]

    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®

  7. Change from Baseline in Flexibility using the sit and reach test [Baseline and 12 weeks immediately after the interventions ends]

  8. Change from Baseline in LDL Cholesterol [Baseline and 12 weeks immediately after the interventions ends]

  9. Change from Baseline in HDL Cholesterol [Baseline and 12 weeks immediately after the interventions ends]

  10. Change from Baseline in Triglycerides [Baseline and 12 weeks immediately after the interventions ends]

  11. Change from Baseline in Glucose [Baseline and 12 weeks immediately after the interventions ends]

  12. Change from Baseline in Hemoglobin A1c [Baseline and 12 weeks immediately after the interventions ends]

  13. Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version [Baseline and 12 weeks immediately after the interventions ends]

  14. Change from Baseline in Heart rate variability [Baseline and 12 weeks immediately after the interventions ends]

    HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware

  15. 24-hour dietary recall [Baseline and 12 weeks immediately after the interventions ends]

    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.

  16. Aortic pulse wave velocity (PWVao) and augmentation index (AIx) [Baseline and 12 weeks immediately after the interventions ends]

    PWVao and AIx will be measured with oscillometric method using the occlusion technique.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robinson Ramírez Vélez Ph.D Bogotá Cundinamarca Colombia

Sponsors and Collaborators

  • Universidad Santo Tomas
  • Universidad del Rosario
  • Universidad Manuela Beltrán

Investigators

  • Principal Investigator: Robinson Ramírez Vélez, Ph.D, Universidad del Rosario

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universidad Santo Tomas
ClinicalTrials.gov Identifier:
NCT02715063
Other Study ID Numbers:
  • 06-1006-2014
First Posted:
Mar 22, 2016
Last Update Posted:
Oct 11, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 11, 2018