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

• ClinicalTrials.gov Identifier: NCT02283047
• Recruitment Status: Completed
• First Posted: November 5, 2014
• Last Update Posted: June 23, 2017
• Sponsor: Basque Country University
• Collaborators: IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava); Servicios Tecnológicos de Tecnalia; Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
• Information provided by (Responsible Party): SARA MALDONADO-MARTIN, Basque Country University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Overweight; Sedentary	Behavioral: DIET; Behavioral: DIET & MODERATE CONTINUOUS TRAINING; Behavioral: DIET & HIGH VOLUME HIIT; Behavioral: DIET & LOW VOLUME HIIT	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effects on Blood Pressure, Cardiorespiratory Condition and Cardiovascular Risk of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People.
• Study Start Date: January 2015
• Actual Primary Completion Date: June 2016
• Actual Study Completion Date: January 2017

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: CONTROL GROUP-DIET; Hypocaloric diet intervention with no supervised exercise intervention	Behavioral: DIET; Lifestyle intervention through hypocaloric diet; Other Name: 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 Name: 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 Name: 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 Name: LV-HIIT

Outcome Measures

Primary Outcome Measures :

1. Blood pressure [ Time Frame: 16-weeks ]
   Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Spain

Faculty of Physical Activity and Sport Sciences

Vitoria-gasteiz, Araba/alava, Spain, 01007

Sponsors and Collaborators

Basque Country University

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; Basque Country University

More Information

Additional Information:

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 

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. Erratum in: J Hypertens. 2007 Oct;25(10):2184.

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.

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.

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. Review.

Jiménez-Pavón D, Ortega FB, Artero EG, Labayen I, Vicente-Rodriguez G, Huybrechts I, Moreno LA, Manios Y, Béghin L, Polito A, De Henauw S, Sjöström M, Castillo MJ, González-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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gorostegi-Anduaga I, Corres P, MartinezAguirre-Betolaza A, Pérez-Asenjo J, Aispuru GR, Fryer SM, Maldonado-Martín 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.

• Responsible Party: SARA MALDONADO-MARTIN, Dr. Sara Maldonado-Martin PhD, Basque Country University
• ClinicalTrials.gov Identifier: NCT02283047
• Other Study ID Numbers: EHU14/08
• First Posted: November 5, 2014
• Last Update Posted: June 23, 2017
• Last Verified: June 2017

Keywords provided by SARA MALDONADO-MARTIN, Basque Country University:

cardiovascular risk, obesity, interval training, diet

Additional relevant MeSH terms:

Overweight; Body Weight