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

Hypertension Clinical Trial

— EXERDIET-HTA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02283047
• Other study ID #: EHU14/08
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: June 22, 2017
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: June 2017
• Source: Basque Country University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: January 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Overweight
• Sedentary

Intervention

Behavioral:
• DIET
Lifestyle intervention through hypocaloric diet
• DIET & MODERATE CONTINUOUS TRAINING
Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
• DIET & HIGH VOLUME HIIT
Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
• DIET & LOW VOLUME HIIT
Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).

Locations

Country	Name	City	State
Spain	Faculty of Physical Activity and Sport Sciences	Vitoria-gasteiz	Araba/alava

Sponsors (4)

Lead Sponsor	Collaborator
Basque Country University	Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos), IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava), Servicios Tecnológicos de Tecnalia

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood pressure	Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure	16-weeks
Secondary	Health related Quality of life (QoL)	Questionnaire SF-36	16-weeks
Secondary	Incremental shuttle walk test (ISWT)	Field test	16-weeks
Secondary	Ventilatory threshold (VT)	the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production	16-weeks
Secondary	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	16-weeks
Secondary	Physical activity and sedentary behavior	Accelerometry and The International Physical Activity Questionnaires	16-weeks
Secondary	Peak Oxygen Uptake (VO2peak)	Cardiovascular peak aerobic capacity	16-weeks
Secondary	Anthropometry	Body mass, body mass index, waist-hip ratio	16-weeks

External 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