Clinical trial NCT02283047: Effects of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Overweight
Sedentary
Keywords: cardiovascular risk, obesity, interval training, diet
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
Collaborators: name: IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
name: Servicios Tecnológicos de Tecnalia
name: Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
First posted: 2014-11-05
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Blood pressure
timeFrame: 16-weeks
Secondary outcomes:
measure: Health related Quality of life (QoL)
timeFrame: 16-weeks
measure: Incremental shuttle walk test (ISWT)
timeFrame: 16-weeks
measure: Ventilatory threshold (VT)
timeFrame: 16-weeks
measure: Biochemical variables
timeFrame: 16-weeks
measure: Physical activity and sedentary behavior
timeFrame: 16-weeks
measure: Peak Oxygen Uptake (VO2peak)
timeFrame: 16-weeks
measure: Anthropometry
timeFrame: 16-weeks
Other outcomes:
Locations:
city: Vitoria-gasteiz
country: Spain
facility: Faculty of Physical Activity and Sport Sciences
state: Araba/alava
Study officials:
affiliation: University of the Basque Country (UPV/EHU)
name: SARA MALDONADO-MARTIN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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.
citation: 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.