Cardiometabolic HIIT-RT Study

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02715063
• Other study ID #: 06-1006-2014
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: October 2018
• Source: Universidad Santo Tomas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Diseases
• Motor Activity
• Overweight

Intervention

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

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

Locations

Country	Name	City	State
Colombia	Robinson Ramírez Vélez Ph.D	Bogotá	Cundinamarca

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Santo Tomas	Universidad del Rosario, Universidad Manuela Beltrán

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and 12 weeks immediately after the interventions ends
Secondary	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	Baseline and 12 weeks immediately after the interventions ends
Secondary	Body Weight		Baseline and 12 weeks immediately after the interventions ends
Secondary	Body Mass Index	BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.	Baseline and 12 weeks immediately after the interventions ends
Secondary	Blood Pressure		Baseline and 12 weeks immediately after the interventions ends
Secondary	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	Baseline and 12 weeks immediately after the interventions ends
Secondary	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®	Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in Flexibility using the sit and reach test		Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in LDL Cholesterol		Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in HDL Cholesterol		Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in Triglycerides		Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in Glucose		Baseline and 12 weeks immediately after the interventions ends
Secondary	Change from Baseline in Hemoglobin A1c		Baseline and 12 weeks immediately after the interventions ends
Secondary	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
Secondary	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	Baseline and 12 weeks immediately after the interventions ends
Secondary	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.	Baseline and 12 weeks immediately after the interventions ends
Secondary	Aortic pulse wave velocity (PWVao) and augmentation index (AIx)	PWVao and AIx will be measured with oscillometric method using the occlusion technique.	Baseline and 12 weeks immediately after the interventions ends