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HypertensionEXERDIET-HTANCT02283047

Effects of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People

A study testing DIET, DIET & MODERATE CONTINUOUS TRAINING and DIET & HIGH VOLUME HIIT in people with Hypertension and Overweight, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hypertension, Overweight, Sedentary
What is being tested?
DIET, DIET & MODERATE CONTINUOUS TRAINING and DIET & HIGH VOLUME HIIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
176 participants
Where
1 siteSpain
Study dates
Jan 2015to Jan 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Physical Activity and Sport Sciences

    Vitoria-Gasteiz, Araba/alava, 01007

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
DIET, DIET & MODERATE CONTINUOUS TRAINING, DIET & HIGH VOLUME HIIT, DIET & LOW VOLUME HIIT
Keywords
cardiovascular risk, obesity, interval training, diet
Medical subject headings
Hypertension, Overweight, Sedentary Behavior, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DIETBehavioural

    Also called CONTROL GROUP

    Lifestyle intervention through hypocaloric diet

  • DIET & MODERATE CONTINUOUS TRAININGBehavioural

    Also called MCT

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

  • DIET & HIGH VOLUME HIITBehavioural

    Also called HV-HIIT

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

  • DIET & LOW VOLUME HIITBehavioural

    Also called LV-HIIT

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

Study groups in NCT02283047
Study groupRoleWhat they receive
CONTROL GROUP-DIETActive comparatorHypocaloric diet intervention with no supervised exercise intervention
Receives: Behavioral: DIET
DIET & MODERATE CONTINUOUS TRAININGExperimentalIntervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)
Receives: Behavioral: DIET & MODERATE CONTINUOUS TRAINING
DIET & HIGH VOLUME HIITExperimentalIntervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)
Receives: Behavioral: DIET & HIGH VOLUME HIIT
DIET & LOW VOLUME HIITExperimentalIntervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
Receives: Behavioral: DIET & LOW VOLUME HIIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood pressure

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

    Measured: 16-weeks

Secondary outcomes (7)

  1. Health related Quality of life (QoL)

    Questionnaire SF-36

    Measured: 16-weeks

  2. Incremental shuttle walk test (ISWT)

    Field test

    Measured: 16-weeks

  3. Ventilatory threshold (VT)

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

    Measured: 16-weeks

  4. Biochemical variables

    Glucose, Insulin, Leptin, Adiponectin,Total-Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, C-reactive protein, aspartate transaminase, alanine transaminase, gamma-glutaryl transferase, Fibrinogen Uric acid

    Measured: 16-weeks

  5. Physical activity and sedentary behavior

    Accelerometry and The International Physical Activity Questionnaires

    Measured: 16-weeks

  6. Peak Oxygen Uptake (VO2peak)

    Cardiovascular peak aerobic capacity

    Measured: 16-weeks

  7. Anthropometry

    Body mass, body mass index, waist-hip ratio

    Measured: 16-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2016
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
176 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283047
Sponsor's protocol ID
EHU14/08
Acronym
EXERDIET-HTA
Status last verified
Jun 2017
First submitted
21 Oct 2014
Last updated
23 Jun 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Mancia G, De Backer G, Dominiczak A, Cifkova R, Fagard R, Germano G, Grassi G, Heagerty AM, Kjeldsen SE, Laurent S, Narkiewicz K, Ruilope L, Rynkiewicz A, Schmieder RE, Boudier HA, Zanchetti A; ESH-ESC Task Force on the Management of Arterial Hypertension. 2007 ESH-ESC Practice Guidelines for the Management of Arterial Hypertension: ESH-ESC Task Force on the Management of Arterial Hypertension. J Hypertens. 2007 Sep;25(9):1751-62. doi: 10.1097/HJH.0b013e3282f0580f. No abstract available.

    PubMed 17762635

  • Agueda M, Lasa A, Simon E, Ares R, Larrarte E, Labayen I. Association of circulating visfatin concentrations with insulin resistance and low-grade inflammation after dietary energy restriction in Spanish obese non-diabetic women: role of body composition changes. Nutr Metab Cardiovasc Dis. 2012 Mar;22(3):208-14. doi: 10.1016/j.numecd.2010.06.010. Epub 2010 Oct 14.

    PubMed 20951014

  • Cornelissen VA, Goetschalckx K, Verheyden B, Aubert AE, Arnout J, Persu A, Rademakers F, Fagard RH. Effect of endurance training on blood pressure regulation, biomarkers and the heart in subjects at a higher age. Scand J Med Sci Sports. 2011 Aug;21(4):526-34. doi: 10.1111/j.1600-0838.2010.01094.x. Epub 2010 Mar 10.

    PubMed 20459467

  • Gibala MJ, Little JP, Macdonald MJ, Hawley JA. Physiological adaptations to low-volume, high-intensity interval training in health and disease. J Physiol. 2012 Mar 1;590(5):1077-84. doi: 10.1113/jphysiol.2011.224725. Epub 2012 Jan 30.

    PubMed 22289907

  • Jimenez-Pavon D, Ortega FB, Artero EG, Labayen I, Vicente-Rodriguez G, Huybrechts I, Moreno LA, Manios Y, Beghin L, Polito A, De Henauw S, Sjostrom M, Castillo MJ, Gonzalez-Gross M, Ruiz JR; HELENA Study Group. Physical activity, fitness, and serum leptin concentrations in adolescents. J Pediatr. 2012 Apr;160(4):598-603.e2. doi: 10.1016/j.jpeds.2011.09.058. Epub 2011 Nov 13.

    PubMed 22082954

  • Molmen-Hansen HE, Stolen T, Tjonna AE, Aamot IL, Ekeberg IS, Tyldum GA, Wisloff U, Ingul CB, Stoylen A. Aerobic interval training reduces blood pressure and improves myocardial function in hypertensive patients. Eur J Prev Cardiol. 2012 Apr;19(2):151-60. doi: 10.1177/1741826711400512. Epub 2011 Mar 4.

    PubMed 21450580

  • Gorostegi-Anduaga I, Tous-Espelosin M, Maldonado-Martin S. Does greater adherence to a healthy dietary pattern correspond to a better body composition and cardiorespiratory fitness in adults with overweight and primary hypertension? Data from the EXERDIET-HTA study. Blood Press Monit. 2025 Jun 1;30(3):104-108. doi: 10.1097/MBP.0000000000000731.

    PubMed 39436237

  • Gorostegi-Anduaga I, Corres P, MartinezAguirre-Betolaza A, Perez-Asenjo J, Aispuru GR, Fryer SM, Maldonado-Martin S. Effects of different aerobic exercise programmes with nutritional intervention in sedentary adults with overweight/obesity and hypertension: EXERDIET-HTA study. Eur J Prev Cardiol. 2018 Mar;25(4):343-353. doi: 10.1177/2047487317749956. Epub 2018 Jan 9.

    PubMed 29313359

Questions about this trial

What is this clinical trial studying?

A study testing DIET, DIET & MODERATE CONTINUOUS TRAINING and DIET & HIGH VOLUME HIIT in people with Hypertension and Overweight, run by University of the Basque Country (UPV/EHU) at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure (time frame: 16-weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283047, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2017.

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EXERDIET-HTA Clinical Trial NCT02283047 | AzTrials