Clinical Trials Directory

Trials / Completed

CompletedNCT02283047

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
176 (actual)
Sponsor
University of the Basque Country (UPV/EHU) · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALDIETLifestyle intervention through hypocaloric diet
BEHAVIORALDIET & MODERATE CONTINUOUS TRAININGLifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
BEHAVIORALDIET & HIGH VOLUME HIITLifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
BEHAVIORALDIET & LOW VOLUME HIITLifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).

Timeline

Start date
2015-01-01
Primary completion
2016-06-01
Completion
2017-01-01
First posted
2014-11-05
Last updated
2017-06-23

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT02283047. Inclusion in this directory is not an endorsement.