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

Not Applicable

Completed

• Conditions: Sedentary; Hypertension; Overweight
• Interventions: Behavioral: DIET & LOW VOLUME HIIT; Behavioral: DIET; Behavioral: DIET & MODERATE CONTINUOUS TRAINING; Behavioral: DIET & HIGH VOLUME HIIT

• Registration Number: NCT02283047
• Lead Sponsor: University of the Basque Country (UPV/EHU)

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.

Study Timeline

• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-11-04
• Study First Posted: 2014-11-05
• Study Start: 2015-01
• Primary Completion: 2016-06
• Study Completion: 2017-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-22
• Last Update Posted: 2017-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DIET & LOW VOLUME HIIT	DIET & LOW VOLUME HIIT	Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
CONTROL GROUP-DIET	DIET	Hypocaloric diet intervention with no supervised exercise intervention
DIET & MODERATE CONTINUOUS TRAINING	DIET & MODERATE CONTINUOUS TRAINING	Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)
DIET & HIGH VOLUME HIIT	DIET & HIGH VOLUME HIIT	Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)

Primary Outcome Measures

Name	Time	Method
Blood pressure	16-weeks	Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure

Secondary Outcome Measures

Name	Time	Method
Peak Oxygen Uptake (VO2peak)	16-weeks	Cardiovascular peak aerobic capacity
Health related Quality of life (QoL)	16-weeks	Questionnaire SF-36
Ventilatory threshold (VT)	16-weeks	the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production
Biochemical variables	16-weeks	Glucose, Insulin, Leptin, Adiponectin,Total-Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, C-reactive protein, aspartate transaminase, alanine transaminase, gamma-glutaryl transferase, Fibrinogen Uric acid
Physical activity and sedentary behavior	16-weeks	Accelerometry and The International Physical Activity Questionnaires
Incremental shuttle walk test (ISWT)	16-weeks	Field test
Anthropometry	16-weeks	Body mass, body mass index, waist-hip ratio

Trial Locations

Locations (1)

Faculty of Physical Activity and Sport Sciences; 🇪🇸 Vitoria-gasteiz, Araba/alava, Spain