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

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ClinicalTrials.gov Identifier: NCT02283047
Recruitment Status : Completed
First Posted : November 5, 2014
Last Update Posted : June 23, 2017
Sponsor:
Collaborators:
IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
Servicios Tecnológicos de Tecnalia
Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
Information provided by (Responsible Party):
SARA MALDONADO-MARTIN, Basque Country University

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.

Condition or disease Intervention/treatment Phase
Hypertension Overweight Sedentary Behavioral: DIET Behavioral: DIET & MODERATE CONTINUOUS TRAINING Behavioral: DIET & HIGH VOLUME HIIT Behavioral: DIET & LOW VOLUME HIIT Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : January 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: CONTROL GROUP-DIET
Hypocaloric diet intervention with no supervised exercise intervention
Behavioral: DIET
Lifestyle intervention through hypocaloric diet
Other Name: CONTROL GROUP

Experimental: 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)
Behavioral: DIET & MODERATE CONTINUOUS TRAINING
Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
Other Name: MCT

Experimental: 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)
Behavioral: DIET & HIGH VOLUME HIIT
Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
Other Name: HV-HIIT

Experimental: DIET & LOW VOLUME HIIT
Intervention with hypocaloric diet and supervised high intensity interval training (85-95%HRpeak). Low volume training (20 min)
Behavioral: DIET & LOW VOLUME HIIT
Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).
Other Name: LV-HIIT




Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 16-weeks ]
    Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure


Secondary Outcome Measures :
  1. Health related Quality of life (QoL) [ Time Frame: 16-weeks ]
    Questionnaire SF-36

  2. Incremental shuttle walk test (ISWT) [ Time Frame: 16-weeks ]
    Field test

  3. Ventilatory threshold (VT) [ Time Frame: 16-weeks ]
    the VT is the 'point of transition between predominantly aerobic energy production to anaerobic energy production

  4. Biochemical variables [ Time Frame: 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

  5. Physical activity and sedentary behavior [ Time Frame: 16-weeks ]
    Accelerometry and The International Physical Activity Questionnaires

  6. Peak Oxygen Uptake (VO2peak) [ Time Frame: 16-weeks ]
    Cardiovascular peak aerobic capacity

  7. Anthropometry [ Time Frame: 16-weeks ]
    Body mass, body mass index, waist-hip ratio



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02283047


Locations
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Spain
Faculty of Physical Activity and Sport Sciences
Vitoria-gasteiz, Araba/alava, Spain, 01007
Sponsors and Collaborators
Basque Country University
IMQ-Igualatorio Médico Quirúrgico, Vitoria-Gasteiz (Araba/Álava)
Servicios Tecnológicos de Tecnalia
Hospital Comarcal Santiago Apostol, Miranda de Ebro (Burgos)
Investigators
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Principal Investigator: SARA MALDONADO-MARTIN, PhD Basque Country University
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: SARA MALDONADO-MARTIN, Dr. Sara Maldonado-Martin PhD, Basque Country University
ClinicalTrials.gov Identifier: NCT02283047    
Other Study ID Numbers: EHU14/08
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Keywords provided by SARA MALDONADO-MARTIN, Basque Country University:
cardiovascular risk, obesity, interval training, diet
Additional relevant MeSH terms:
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Overweight
Body Weight