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

University of the Basque Country (UPV/EHU)

Status: Completed

Conditions: Sedentary; Hypertension; Overweight

Treatments: Behavioral: DIET & LOW VOLUME HIIT; Behavioral: DIET; Behavioral: DIET & MODERATE CONTINUOUS TRAINING; Behavioral: DIET & HIGH VOLUME HIIT

Study type: Interventional

Funder types: Other

Identifiers

NCT02283047

EHU14/08

Details and patient eligibility

About

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.

Full 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.

Enrollment: 176 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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176 participants in 4 patient groups

CONTROL GROUP-DIET

Active Comparator group

Description:

Hypocaloric diet intervention with no supervised exercise intervention

Treatment:

Behavioral: DIET

DIET & MODERATE CONTINUOUS TRAINING

Experimental group

Description:

Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)

Treatment:

Behavioral: DIET & MODERATE CONTINUOUS TRAINING

DIET & HIGH VOLUME HIIT

Experimental group

Description:

Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)

Treatment:

Behavioral: DIET & HIGH VOLUME HIIT

DIET & LOW VOLUME HIIT

Experimental group

Description:

Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)

Treatment:

Behavioral: DIET & LOW VOLUME HIIT