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Clinical Trials/NCT03000140
NCT03000140CompletedNot Applicable

Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects

Universidad Santo Tomas1 site in 1 country142 target enrollmentStarted: March 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
142
Locations
1
Primary Endpoint
Change from Baseline in systolic blood pressure and diastolic blood pressure

Study Overview

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).

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Investigator)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

High Intensity Interval Training

Experimental

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.

Intervention: High Intensity Interval Training (Behavioral)

Control group

Active Comparator

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.

Intervention: Control group (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Change from Baseline in waist circumference(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in fat mass(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in body mass index(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in body mass(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in one maximum repetition strength test of leg-extension exercise(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in heart rate at rest(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in fasting glucose(Baseline and 16 weeks immediately after the interventions ends)
  • Change from Baseline in lipids(Baseline and 16 weeks immediately after the interventions ends)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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