Skip to main content
OpenTrials
Completed

NCT Number: NCT02715063

Cardiometabolic HIIT-RT Study

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Metabolic Diseases Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Robinson Ramírez Vélez Ph.D

Bogotá, Cundinamarca, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Intensity Interval

Behavioral

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

Resistance training

Behavioral

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

Plus: High Intensity Interval + Resistance Training

Behavioral

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

usual clinical care

Other

Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein

Primary outcomes

  1. Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)

    Time frame: 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 outcomes

  1. Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry

    Time frame: 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

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  3. Body Mass Index

    Time frame: 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

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  5. Change from Baseline in peak uptake of volume of oxygen

    Time frame: 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

    Time frame: 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

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  8. Change from Baseline in LDL Cholesterol

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  9. Change from Baseline in HDL Cholesterol

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  10. Change from Baseline in Triglycerides

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  11. Change from Baseline in Glucose

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  12. Change from Baseline in Hemoglobin A1c

    Time frame: 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

    Time frame: Baseline and 12 weeks immediately after the interventions ends

  14. Change from Baseline in Heart rate variability

    Time frame: 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

    Time frame: 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)

    Time frame: Baseline and 12 weeks immediately after the interventions ends

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

Sponsors and collaborators

Lead sponsor

Universidad Santo Tomas

Other

Collaborators

  • Universidad Manuela Beltrán
  • Universidad del Rosario

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Mar 22, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.