Effects of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People (EXERDIET-HTA)

June 22, 2017 updated by: SARA MALDONADO-MARTIN, University of the Basque Country (UPV/EHU)

Effects on Blood Pressure, Cardiorespiratory Condition and Cardiovascular Risk of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People.

Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover, the concept that obesity and HTN can be additive in terms of cardiovascular rist is widely accepted. Yet, clinical decision-making in obese patients is complicated by a surprising lack of evidence on the relative importance of obesity and HTN treatment and its efficacy and safety. Lifestyle interventions are the mainstay of obesity management programs and are also advocated in the prevention and treatment of HTN. Physical exercise and diet are recommended to prevent and control obesity and HTN. Aerobic exercise is firmly established as an effective measure for lowering blood pressure and reducing cardiovascular risk. However, there is no agreement about the optimal dose of frequency, intensity, duration and type of exercise. Therefore, the aims of the study are: 1) to assess the changes in selected parameters of blood pressure, cardiorespiratory fitness, body composition and biological markers brought about by a period of 16-week of different aerobic exercise programs with hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to examine the effect of six months detraining subsequent to intervention. Secondary objectives are to examine the additional effect of the intervention on physical activity behavior and health-related quality of life.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

METHODOLOGY: participants will perform a ramp incremental cardiopulmonary exercise bike test before, after 16-week of follow-up, and after 6-month detraining period (with no intervention only recommendations). After inclusion criteria they will be randomized to four parallel groups: 1) control group with only hypocaloric diet intervention and lifestyle recommendations; 2) Moderate (HR values between VT1 and VT2 or 50-75% of HR reserve) continuous exercise and high volume (from 20 to 45min) group and hypocaloric diet intervention; 3) high intensity (HR values up to VT2 to peak intensity or ≥76% to <100 % of HR reserve) interval training and high-volume (from 20 to 45min) group alternating high and moderate intensities at different protocols and hypocaloric diet intervention; and 4) high-intensity interval training and low-volume (20min) group alternating high and moderate intensities at different protocolsand hypocaloric diet intervention.

Study Type

Interventional

Enrollment (Actual)

176

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Araba/alava
      • Vitoria-gasteiz, Araba/alava, Spain, 01007
        • Faculty of physical activity and sport sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • older than 18yr old and less than 70yr old
  • overweight (BMI >25)
  • primary hypertension
  • low-moderate cardiovascular risk
  • not diet treatment
  • sedentary behavior
  • availability to exercise two days a week.

Exclusion Criteria:

  • secondary hypertension
  • pulmonary disorder
  • neurological deficit
  • physical incapacity to exercise
  • to exercise frequently
  • pregnancy or breastfeeding
  • left ventricular hypertrophy
  • more than three cardiovascular risk factors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CONTROL GROUP-DIET
Hypocaloric diet intervention with no supervised exercise intervention
Behavioral: DIET
Lifestyle intervention through hypocaloric diet
Other Names:
  • CONTROL GROUP
Experimental: DIET & MODERATE CONTINUOUS TRAINING
Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)
Behavioral: DIET & MODERATE CONTINUOUS TRAINING
Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
Other Names:
  • MCT
Experimental: DIET & HIGH VOLUME HIIT
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)
Behavioral: DIET & HIGH VOLUME HIIT
Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
Other Names:
  • HV-HIIT
Experimental: DIET & LOW VOLUME HIIT
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
Behavioral: DIET & LOW VOLUME HIIT
Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).
Other Names:
  • LV-HIIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: 16-weeks
Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure
16-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related Quality of life (QoL)
Time Frame: 16-weeks
Questionnaire SF-36
16-weeks
Incremental shuttle walk test (ISWT)
Time Frame: 16-weeks
Field test
16-weeks
Ventilatory threshold (VT)
Time Frame: 16-weeks
the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production
16-weeks
Biochemical variables
Time Frame: 16-weeks
Glucose, Insulin, Leptin, Adiponectin,Total-Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, C-reactive protein, aspartate transaminase, alanine transaminase, gamma-glutaryl transferase, Fibrinogen Uric acid
16-weeks
Physical activity and sedentary behavior
Time Frame: 16-weeks
Accelerometry and The International Physical Activity Questionnaires
16-weeks
Peak Oxygen Uptake (VO2peak)
Time Frame: 16-weeks
Cardiovascular peak aerobic capacity
16-weeks
Anthropometry
Time Frame: 16-weeks
Body mass, body mass index, waist-hip ratio
16-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Basque Country (UPV/EHU)

Collaborators

IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
Servicios Tecnológicos de Tecnalia
Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)

Investigators

  • Principal Investigator: SARA MALDONADO-MARTIN, PhD, University of the Basque Country (UPV/EHU)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

November 4, 2014

First Posted (Estimate)

November 5, 2014

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 22, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHU14/08

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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