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Completed

NCT Number: NCT02283047

Effects 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.

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Key information

Conditions

Hypertension Behavior Body Weight Cardiovascular Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Sedentary Sedentary Behavior Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Activity and Sport Sciences

Vitoria-Gasteiz, Araba/alava, 01007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Diet

Behavioral

Lifestyle intervention through hypocaloric diet

Other names: CONTROL GROUP

DIET & MODERATE CONTINUOUS TRAINING

Behavioral

Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).

Other names: MCT

DIET & HIGH VOLUME HIIT

Behavioral

Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).

Other names: HV-HIIT

DIET & LOW VOLUME HIIT

Behavioral

Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).

Other names: LV-HIIT

Primary outcomes

  1. Blood pressure

    Time frame: 16-weeks

    Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure

Secondary outcomes

  1. Health related Quality of life (QoL)

    Time frame: 16-weeks

    Questionnaire SF-36

  2. Incremental shuttle walk test (ISWT)

    Time frame: 16-weeks

    Field test

  3. Ventilatory threshold (VT)

    Time frame: 16-weeks

    the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production

  4. 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

  5. Physical activity and sedentary behavior

    Time frame: 16-weeks

    Accelerometry and The International Physical Activity Questionnaires

  6. Peak Oxygen Uptake (VO2peak)

    Time frame: 16-weeks

    Cardiovascular peak aerobic capacity

  7. Anthropometry

    Time frame: 16-weeks

    Body mass, body mass index, waist-hip ratio

Sponsors and collaborators

Lead sponsor

University of the Basque Country (UPV/EHU)

Other

Collaborators

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

Registry information

Official study title

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

Acronym: EXERDIET-HTA

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Nov 5, 2014
Registry last updated
Jun 23, 2017

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.

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