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

NCT02283047 | Completed DMC

• 1 other identifier: EHU14/08
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hypertension; Overweight; Sedentary

Keywords

cardiovascular risk, obesity, interval training, diet

Outcome Measures

Primary Outcomes (1)

• Blood pressure

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

  16-weeks

Secondary Outcomes (7)

• Health related Quality of life (QoL)

  16-weeks

• Incremental shuttle walk test (ISWT)

  16-weeks

• Ventilatory threshold (VT)

  16-weeks

• Biochemical variables

  16-weeks

• Physical activity and sedentary behavior

  16-weeks

Study Arms (4)

CONTROL GROUP-DIET

ACTIVE COMPARATOR

Hypocaloric diet intervention with no supervised exercise intervention

Behavioral: DIET

DIET & MODERATE CONTINUOUS TRAINING

EXPERIMENTAL

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

DIET & HIGH VOLUME HIIT

EXPERIMENTAL

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

DIET & LOW VOLUME HIIT

EXPERIMENTAL

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

Behavioral: DIET & LOW VOLUME HIIT

Interventions

DIET BEHAVIORAL

Lifestyle intervention through hypocaloric diet

Also known as: CONTROL GROUP

CONTROL GROUP-DIET

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).

Also known as: MCT

DIET & MODERATE CONTINUOUS TRAINING

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).

Also known as: HV-HIIT

DIET & HIGH VOLUME 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).

Also known as: LV-HIIT

DIET & LOW VOLUME HIIT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Basque Country (UPV/EHU): lead
• IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava): collaborator
• Servicios Tecnológicos de Tecnalia: collaborator
• Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos): collaborator

Study Sites (1)

Faculty of Physical Activity and Sport Sciences

Vitoria-Gasteiz, Araba/alava, 01007, Spain

Location

Related Publications (8)

• 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.

  PMID: 17762635 BACKGROUND

• 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.

  PMID: 20951014 BACKGROUND

• 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.

  PMID: 20459467 BACKGROUND

• 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.

  PMID: 22289907 BACKGROUND

• 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.

  PMID: 22082954 BACKGROUND

• 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.

  PMID: 21450580 BACKGROUND

• 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.

  PMID: 39436237 DERIVED

• 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.

  PMID: 29313359 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Hypertension; Overweight; Sedentary Behavior; Obesity

Interventions

Diet; Control Groups

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• SARA MALDONADO-MARTIN, PhD

  University of the Basque Country (UPV/EHU)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sara Maldonado-Martin PhD

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: November 5, 2014
• Study Start: January 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: January 1, 2017
• Last Updated: June 23, 2017

Record last verified: 2017-06

Locations

ES (1)