Metabolism DisorderNCT03000140

High-Intensity Interval Training on Pre-Hypertensive Subjects

A study testing High Intensity Interval Training in people with Metabolism Disorder and Hypertension, run by Universidad Santo Tomas at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 20 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for: Metabolism Disorder, Hypertension
What is being tested?: High Intensity Interval Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 142 participants
Where: 1 siteChile
Study dates: Mar 2015to Feb 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 40 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

Cristian Alvarez
Osorno

Other trials in Chile

About this study

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

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).

Read the detailed description

Conditions: Metabolism Disorder, Hypertension
Being tested: High Intensity Interval Training, Control group
Medical subject headings: Metabolic Diseases, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High Intensity Interval TrainingBehavioural
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.
Control groupBehavioural
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.

Study groups in NCT03000140
Study group	Role	What they receive
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. Receives: Behavioral: High Intensity Interval Training
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. Receives: Behavioral: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in systolic blood pressure and diastolic blood pressure
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.
Measured: Baseline and 16 weeks immediately after the interventions ends

Secondary outcomes (8)

Change from Baseline in body mass
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in body mass index
BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in waist circumference
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in fat mass
Measured: 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
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in fasting glucose
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in lipids
Lipid profile (low-density cholesterol, total cholesterol, high-density cholesterol and triglycerides)
Measured: Baseline and 16 weeks immediately after the interventions ends
Change from Baseline in one maximum repetition strength test of leg-extension exercise
Measured: Baseline and 16 weeks immediately after the interventions ends

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Feb 2017

First posted21 Dec 2016 (estimated)
Study startMar 2015
Primary completionDec 2016
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Metabolism DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03000140
Sponsor's protocol ID: Number 03052015
Status last verified: Oct 2018
First submitted: 17 Dec 2016
Last updated: 11 Oct 2018
Results posted: No
Data monitoring committee: Yes

Publications

Alvarez C, Ramirez-Campillo R, Cristi-Montero C, Ramirez-Velez R, Izquierdo M. Prevalence of Non-responders for Blood Pressure and Cardiometabolic Risk Factors Among Prehypertensive Women After Long-Term High-Intensity Interval Training. Front Physiol. 2018 Oct 23;9:1443. doi: 10.3389/fphys.2018.01443. eCollection 2018.
PubMed 30405426

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Health Status Factors Predicting Responses to Long-Term Training: Effects of 16-Week High-Intensity Interval Training on Pre-Hypertensive Subjects
ClinicalTrials.gov ID: NCT03000140
Acronym / sponsor ID: Number 03052015
Conditions: Metabolism Disorder, Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Universidad Santo TomasUniversity, hospital or other
Collaborators: Healthcare Center Tomas Rojas, University of Los Ríos, Universidad Pública de Navarra, Universidad del Rosario
Study start: Mar 2015
Primary completion: Dec 2016 (actual)
Study completion: Feb 2017 (actual)
First posted: 21 Dec 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
High Intensity Interval Training	Experimental	Behavioral: High Intensity Interval TrainingCycling 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.
Control group	Active comparator	Behavioral: Control groupPre-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.

Who may qualify

Ages: 20 to 40 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High Intensity Interval TrainingHigh 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.	Behavioural	High Intensity Interval Training
Control groupModerade 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.	Behavioural	Control group

Primary outcome

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.

8 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
Derived from this study: PubMed 30405426Alvarez C, Ramirez-Campillo R, Cristi-Montero C, Ramirez-Velez R, Izquierdo M. Prevalence of Non-responders for Blood Pressure and Cardiometabolic Risk Factors Among Prehypertensive Women After Long-Term High-Intensity Interval Training. Front Physiol. 2018 Oct 23;9:1443. doi: 10.3389/fphys.2018.01443. eCollection 2018.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training in people with Metabolism Disorder and Hypertension, run by Universidad Santo Tomas at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in systolic blood pressure and diastolic blood pressure (time frame: Baseline and 16 weeks immediately after the interventions ends). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03000140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2018.