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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02283047
Acronym
EXERDIET-HTA
Enrollment
176
Registered
2014-11-05
Start date
2015-01-31
Completion date
2017-01-31
Last updated
2017-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Overweight, Sedentary

Keywords

cardiovascular risk, obesity, interval training, diet

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.

Interventions

BEHAVIORALDIET

Lifestyle intervention through hypocaloric diet

BEHAVIORALDIET & MODERATE CONTINUOUS TRAINING

Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).

BEHAVIORALDIET & HIGH VOLUME HIIT

Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).

BEHAVIORALDIET & LOW VOLUME HIIT

Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).

Sponsors

IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
CollaboratorUNKNOWN
Servicios Tecnológicos de Tecnalia
CollaboratorUNKNOWN
Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
CollaboratorUNKNOWN
University of the Basque Country (UPV/EHU)
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood pressure16-weeksAmbulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure

Secondary

MeasureTime frameDescription
Incremental shuttle walk test (ISWT)16-weeksField test
Ventilatory threshold (VT)16-weeksthe VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production
Biochemical variables16-weeksGlucose, Insulin, Leptin, Adiponectin,Total-Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, C-reactive protein, aspartate transaminase, alanine transaminase, gamma-glutaryl transferase, Fibrinogen Uric acid
Health related Quality of life (QoL)16-weeksQuestionnaire SF-36
Peak Oxygen Uptake (VO2peak)16-weeksCardiovascular peak aerobic capacity
Anthropometry16-weeksBody mass, body mass index, waist-hip ratio
Physical activity and sedentary behavior16-weeksAccelerometry and The International Physical Activity Questionnaires

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026