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

Study Overview
=================
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.

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

Conditions
-----------------
Hypertension, Overweight, Sedentary

Intervention / Treatment
-----------------
* Behavioral: DIET
* Behavioral: DIET & MODERATE CONTINUOUS TRAINING
* Behavioral: DIET & HIGH VOLUME HIIT
* Behavioral: DIET & LOW VOLUME HIIT


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CONTROL GROUP-DIET<br>Hypocaloric diet intervention with no supervised exercise intervention | Behavioral: DIET<br>* Lifestyle intervention through hypocaloric diet<br>* Other names: CONTROL GROUP;|
| Experimental: DIET & MODERATE CONTINUOUS TRAINING<br>Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min) | Behavioral: DIET & MODERATE CONTINUOUS TRAINING<br>* Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).<br>* Other names: MCT;|
| Experimental: DIET & HIGH VOLUME HIIT<br>Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min) | Behavioral: DIET & HIGH VOLUME HIIT<br>* Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).<br>* Other names: HV-HIIT;|
| Experimental: DIET & LOW VOLUME HIIT<br>Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min) | Behavioral: DIET & LOW VOLUME HIIT<br>* Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).<br>* Other names: LV-HIIT;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure | 16-weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related Quality of life (QoL) | Questionnaire SF-36 | 16-weeks | 
| Incremental shuttle walk test (ISWT) | Field test | 16-weeks | 
| Ventilatory threshold (VT) | the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production | 16-weeks | 
| 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 | 
| Physical activity and sedentary behavior | Accelerometry and The International Physical Activity Questionnaires | 16-weeks | 
| Peak Oxygen Uptake (VO2peak) | Cardiovascular peak aerobic capacity | 16-weeks | 
| Anthropometry | Body mass, body mass index, waist-hip ratio | 16-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiovascular risk, obesity, interval training, diet