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

Primary Purpose

Hypertension, Overweight, Sedentary

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
DIET
DIET & MODERATE CONTINUOUS TRAINING
DIET & HIGH VOLUME HIIT
DIET & LOW VOLUME HIIT
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring cardiovascular risk, obesity, interval training, diet

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of Physical Activity and Sport Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

CONTROL GROUP-DIET

DIET & MODERATE CONTINUOUS TRAINING

DIET & HIGH VOLUME HIIT

DIET & LOW VOLUME HIIT

Arm Description

Hypocaloric diet intervention with no supervised exercise intervention

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

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

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

Outcomes

Primary Outcome Measures

Blood pressure
Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2014
Last Updated
June 22, 2017
Sponsor
University of the Basque Country (UPV/EHU)
Collaborators
IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava), Servicios Tecnológicos de Tecnalia, Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
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1. Study Identification

Unique Protocol Identification Number
NCT02283047
Brief Title
Effects of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People
Acronym
EXERDIET-HTA
Official Title
Effects on Blood Pressure, Cardiorespiratory Condition and Cardiovascular Risk of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)
Collaborators
IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava), Servicios Tecnológicos de Tecnalia, Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Overweight, Sedentary
Keywords
cardiovascular risk, obesity, interval training, diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CONTROL GROUP-DIET
Arm Type
Active Comparator
Arm Description
Hypocaloric diet intervention with no supervised exercise intervention
Arm Title
DIET & MODERATE CONTINUOUS TRAINING
Arm Type
Experimental
Arm Description
Intervention with hypocaloric diet and supervised moderate continuous exercise training (60-80%HRpeak). High volume training (45 minutes in progression from 20 min)
Arm Title
DIET & HIGH VOLUME HIIT
Arm Type
Experimental
Arm Description
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). High volume training (45 minutes in progression from 20 min)
Arm Title
DIET & LOW VOLUME HIIT
Arm Type
Experimental
Arm Description
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
Intervention Type
Behavioral
Intervention Name(s)
DIET
Other Intervention Name(s)
CONTROL GROUP
Intervention Description
Lifestyle intervention through hypocaloric diet
Intervention Type
Behavioral
Intervention Name(s)
DIET & MODERATE CONTINUOUS TRAINING
Other Intervention Name(s)
MCT
Intervention Description
Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
Intervention Type
Behavioral
Intervention Name(s)
DIET & HIGH VOLUME HIIT
Other Intervention Name(s)
HV-HIIT
Intervention Description
Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
Intervention Type
Behavioral
Intervention Name(s)
DIET & LOW VOLUME HIIT
Other Intervention Name(s)
LV-HIIT
Intervention Description
Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).
Primary Outcome Measure Information:
Title
Blood pressure
Description
Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure
Time Frame
16-weeks
Secondary Outcome Measure Information:
Title
Health related Quality of life (QoL)
Description
Questionnaire SF-36
Time Frame
16-weeks
Title
Incremental shuttle walk test (ISWT)
Description
Field test
Time Frame
16-weeks
Title
Ventilatory threshold (VT)
Description
the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production
Time Frame
16-weeks
Title
Biochemical variables
Description
Glucose, Insulin, Leptin, Adiponectin,Total-Cholesterol, HDL-cholesterol, LDL-cholesterol, Triglycerides, C-reactive protein, aspartate transaminase, alanine transaminase, gamma-glutaryl transferase, Fibrinogen Uric acid
Time Frame
16-weeks
Title
Physical activity and sedentary behavior
Description
Accelerometry and The International Physical Activity Questionnaires
Time Frame
16-weeks
Title
Peak Oxygen Uptake (VO2peak)
Description
Cardiovascular peak aerobic capacity
Time Frame
16-weeks
Title
Anthropometry
Description
Body mass, body mass index, waist-hip ratio
Time Frame
16-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SARA MALDONADO-MARTIN, PhD
Organizational Affiliation
University of the Basque Country (UPV/EHU)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Activity and Sport Sciences
City
Vitoria-gasteiz
State/Province
Araba/alava
ZIP/Postal Code
01007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
17762635
Citation
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Results Reference
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PubMed Identifier
20951014
Citation
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
22289907
Citation
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Results Reference
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PubMed Identifier
22082954
Citation
Jimenez-Pavon D, Ortega FB, Artero EG, Labayen I, Vicente-Rodriguez G, Huybrechts I, Moreno LA, Manios Y, Beghin L, Polito A, De Henauw S, Sjostrom M, Castillo MJ, Gonzalez-Gross M, Ruiz JR; HELENA Study Group. Physical activity, fitness, and serum leptin concentrations in adolescents. J Pediatr. 2012 Apr;160(4):598-603.e2. doi: 10.1016/j.jpeds.2011.09.058. Epub 2011 Nov 13.
Results Reference
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Citation
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Results Reference
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Citation
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Results Reference
derived
Links:
URL
http://www.ash-us.org/
Description
Given the ever increasing prevalence of hypertension in the United States and the issues involved in treating cases of resistant and complex hypertension, the Leadership of the American Society of Hypertension, Inc. (ASH) recognizes that hypertension can

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

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