Cardiometabolic HIIT-RT Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02715063
• Date of registration: 08/03/2016
• Prospective Registration: No
• Primary sponsor: Universidad Santo Tomas
• Public title: Cardiometabolic HIIT-RT Study
• Scientific 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
• Date of first enrolment: January 2016
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02715063
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Colombia

Contacts

• Name: Robinson Ramírez Vélez, Ph.D
• Affiliation: Universidad del Rosario

Key inclusion & exclusion 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.



Age minimum: 30 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overweight

Motor Activity

Metabolic Diseases

Intervention(s)

Behavioral: Resistance training

Other: Usual clinical care

Behavioral: High Intensity Interval

Behavioral: Plus: High Intensity Interval + Resistance Training

Primary Outcome(s)

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

Secondary Outcome(s)

Body Mass Index [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Body Weight [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

24-hour dietary recall [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Change from Baseline in Flexibility using the sit and reach test [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Change from Baseline in LDL Cholesterol [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

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]

Change from Baseline in HDL Cholesterol [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Change from Baseline in Triglycerides [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Blood Pressure [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Change from Baseline in peak uptake of volume of oxygen [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

Change from Baseline in Glucose [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

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]

Change from Baseline in muscular fitness [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

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

Change from Baseline in Heart rate variability [Time Frame: Baseline and 12 weeks immediately after the interventions ends]

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

Secondary ID(s)

06-1006-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universidad Manuela Beltrán

Universidad del Rosario