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

NCT ID: NCT02283047

Last Updated: 2017-06-23

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

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hypertension Overweight Sedentary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CONTROL GROUP-DIET

Hypocaloric diet intervention with no supervised exercise intervention

Group Type ACTIVE_COMPARATOR

DIET

Intervention Type BEHAVIORAL

Lifestyle intervention through hypocaloric diet

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)

Group Type EXPERIMENTAL

DIET & MODERATE CONTINUOUS TRAINING

Intervention Type BEHAVIORAL

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

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)

Group Type EXPERIMENTAL

DIET & HIGH VOLUME HIIT

Intervention Type BEHAVIORAL

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

DIET & LOW VOLUME HIIT

Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)

Group Type EXPERIMENTAL

DIET & LOW VOLUME HIIT

Intervention Type BEHAVIORAL

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

Interventions

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DIET

Lifestyle intervention through hypocaloric diet

Intervention Type 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).

Intervention Type 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).

Intervention Type BEHAVIORAL

DIET & LOW VOLUME HIIT

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

Intervention Type BEHAVIORAL

Other Intervention Names

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CONTROL GROUP MCT HV-HIIT LV-HIIT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)

UNKNOWN

Sponsor Role collaborator

Servicios Tecnológicos de Tecnalia

UNKNOWN

Sponsor Role collaborator

Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)

UNKNOWN

Sponsor Role collaborator

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role lead

Responsible Party

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SARA MALDONADO-MARTIN

Dr. Sara Maldonado-Martin PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SARA MALDONADO-MARTIN, PhD

Role: PRINCIPAL_INVESTIGATOR

University of the Basque Country (UPV/EHU)

Locations

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Faculty of Physical Activity and Sport Sciences

Vitoria-Gasteiz, Araba/alava, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 17762635 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20951014 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20459467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22289907 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22082954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21450580 (View on PubMed)

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.

Reference Type DERIVED
PMID: 39436237 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29313359 (View on PubMed)

Related Links

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http://www.ash-us.org/

Given the ever increasing prevalence of hypertension in the United States and the issues involved in treating cases of resistant and complex hypertension, the Leadership of the American Society of Hypertension, Inc. (ASH) recognizes that hypertension can

Other Identifiers

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EHU14/08

Identifier Type: -

Identifier Source: org_study_id

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