Overview

This trial is active, not recruiting.

Conditions hypertension, overweight, sedentary
Treatments diet, diet & moderate continuous training, diet & high volume hiit, diet & low volume hiit
Sponsor Basque Country University
Collaborator IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
Start date January 2015
End date June 2016
Trial size 176 participants
Trial identifier NCT02283047, EHU14/08

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Hypocaloric diet intervention with no supervised exercise intervention
diet CONTROL GROUP
Lifestyle intervention through hypocaloric diet
(Experimental)
Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)
diet & moderate continuous training MCT
Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
(Experimental)
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)
diet & high volume hiit HV-HIIT
Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
(Experimental)
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
diet & low volume hiit LV-HIIT
Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).

Primary Outcomes

Measure
Blood pressure
time frame: 16-weeks

Secondary Outcomes

Measure
Health related Quality of life (QoL)
time frame: 16-weeks
Incremental shuttle walk test (ISWT)
time frame: 16-weeks
Ventilatory threshold (VT)
time frame: 16-weeks
Biochemical variables
time frame: 16-weeks
Physical activity and sedentary behavior
time frame: 16-weeks
Peak Oxygen Uptake (VO2peak)
time frame: 16-weeks
Anthropometry
time frame: 16-weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Effects on Blood Pressure, Cardiorespiratory Condition and Cardiovascular Risk of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People.
Principal investigator SARA MALDONADO-MARTIN, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Basque Country University.