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High-Intensity Interval Training on Pre-Hypertensive Subjects

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ClinicalTrials.gov Identifier: NCT03000140
Recruitment Status : Completed
First Posted : December 21, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborators:
Healthcare Center Tomas Rojas
University of Los Ríos
Universidad Pública de Navarra
Universidad del Rosario
Information provided by (Responsible Party):
Universidad Santo Tomas

Brief Summary:
Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Condition or disease Intervention/treatment Phase
Metabolism Disorder Hypertension Behavioral: High Intensity Interval Training Behavioral: Control group Not Applicable

Detailed Description:
Despite exercise training decrease blood pressure in 'average' terms, there is a wide interindividual variability after exercise training, being yet unknown what mode of exercise (e.g. endurance, strength, concurrent, or high intensity interval training) produce more/less non-responder (NR) prevalence (i.e., percentage of subjects who experienced a non-change/worsened response after training in some outcome).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects
Study Start Date : March 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: High Intensity Interval Training
Cycling on cycle ergometers (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) for 1 min at a subjective intensity of 8-10 points of the modified Borg scale of 1-10 points, and interspersed by inactive (without movement over the bicycle) of 2 minutes as recovery period.
Behavioral: High Intensity Interval Training
High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.

Active Comparator: Control group
Pre-hypertensive group was compared with healthy groups in the 2 manin variables systolic/diastolic blood pressure, as well as in other co-variables in pre-post changes. Thus, after the training intervention, and following the R and NR classification, we will compare the NR prevalence between both Pre-hypertensive and Healthy group.
Behavioral: Control group
Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.




Primary Outcome Measures :
  1. Change from Baseline in systolic blood pressure and diastolic blood pressure [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
    After this, we calculated the delta changes in both variables and classified to all subjects in responders (R) and non-responders (NR) to decrease systolic or diastolic blood pressure.


Secondary Outcome Measures :
  1. Change from Baseline in body mass [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
  2. Change from Baseline in body mass index [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
    BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.

  3. Change from Baseline in waist circumference [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
  4. Change from Baseline in fat mass [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
  5. Change from Baseline in heart rate at rest [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
    Baseline and 16 weeks immediately after the interventions ends

  6. Change from Baseline in fasting glucose [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
  7. Change from Baseline in lipids [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]
    Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)

  8. Change from Baseline in one maximum repetition strength test of leg-extension exercise [ Time Frame: Baseline and 16 weeks immediately after the interventions ends ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent;
  • Interested in improving health and fitness;
  • Systolic blood pressure > 120 mmHg and < 140 mmHg, and/or DBP ≥ 80 and < 90 mmHg according with standard classification;
  • No drug therapy during the previous 3 months;
  • Body mass index (BMI) 25 and 35 kg/m2); (c) physically inactive (according to the International Physical Activity Questionnaire previously validated in Chilean population)
  • Normal /mild altered lipid profile (total cholesterol [TC] ~200 and ≤250 mg/dL, low-density lipids [LDL-C] ~140 mg/dL and ≤200 mg/dL, high-density lipids [HDL-C] ≥20 and ~40 mg/dL, triglycerides ~150 and ≤250 mg/dL) according with standard classification.

Exclusion Criteria:

  • Cardiovascular contraindications to exercise histories of stroke;
  • Asthma and chronic obstructive pulmonary disease;
  • Musculoskeletal disorder such as low back pain;
  • Smokers in the last 3 months were not included in the study.

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): NCT03000140


Locations
Chile
Cristian Alvarez
Osorno, Chile
Sponsors and Collaborators
Universidad Santo Tomas
Healthcare Center Tomas Rojas
University of Los Ríos
Universidad Pública de Navarra
Universidad del Rosario

Responsible Party: Universidad Santo Tomas
ClinicalTrials.gov Identifier: NCT03000140     History of Changes
Other Study ID Numbers: Number 03052015
First Posted: December 21, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Metabolic Diseases