Cardiometabolic HIIT-RT Study

NCT ID: NCT02715063

Last Updated: 2018-10-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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).

Conditions

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Metabolic Diseases Overweight Motor Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

High Intensity Interval

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Resistance training

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Plus: High Intensity Interval + Resistance Training

Intervention Type 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

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.

Group Type PLACEBO_COMPARATOR

Usual clinical care

Intervention Type OTHER

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

Interventions

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High Intensity Interval

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

Intervention Type BEHAVIORAL

Resistance training

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Usual clinical care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad del Rosario

OTHER

Sponsor Role collaborator

Universidad Manuela Beltrán

OTHER

Sponsor Role collaborator

Universidad Santo Tomas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robinson Ramírez Vélez, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Universidad del Rosario

Locations

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Robinson Ramírez Vélez Ph.D

Bogotá, Cundinamarca, Colombia

Site Status

Countries

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Colombia

References

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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.

Reference Type DERIVED
PMID: 28934175 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27342073 (View on PubMed)

Other Identifiers

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06-1006-2014

Identifier Type: -

Identifier Source: org_study_id

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