Impact of Aerobic Exercise Training on Sympathetic Vasoconstriction and Vascular Function in Essential Hypertension (IMPROVEH)

November 1, 2022 updated by: Ylva Hellsten, University of Copenhagen

Impact of Aerobic Exercise Training on Sympathetically Mediated Vasoconstriction and Vascular Function in Individuals With Essential Hypertension (IMPROVEH)

Sympathetic nervous activity plays an important role in the development of hypertension and studies have shown that the pannexin-1 channel is involved in the signalling of the sympathetic activity to the vascular bed. The main project aim is to investigate the effects of 10 weeks of high intensity training on the effect of the sympathetic nervous activity on vascular function in individuals with essential hypertension. A secondary aim is to assess the role of essential hypertension and physical activity on vascular endothelial function,

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Sedentary men and women age 35 - 65 years
  • Resting blood pressure >140/90 mmHg or Resting blood pressure <140/90 mmHg
  • Essential hypertension
  • Non or exclusively antihypertensive medication

Exclusion Criteria:

  • Hypertensive condition other than essential hypertension
  • Other chronical diseases
  • Smoking
  • Excess alcohol intake or drug abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hypertensive
Men and women in age-group 35-65 years Resting blood pressure of >140/90 mmHg non or only anti-hypertensive medication
Other: Training
10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.
ACTIVE_COMPARATOR: Control
Men and women in age-group 35-65 years Resting blood pressure of <140/90 mmHg no medication
Other: Training
10 weeks of high intensity exercise training. 2-3 trainings per week of approx. 40 min.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood pressure
Time Frame: Before and after 8 weeks of training
Changes in systolic and diastolic blood pressure
Before and after 8 weeks of training

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pannexin channel function assessed in vivo
Time Frame: Before and after 8 weeks of training
Pannexin channel function is assessed by measurement of vascular conductance with and without channel inhibition
Before and after 8 weeks of training
Pannexin channel distribution in skeletal muscle tissue
Time Frame: Before and after 8 weeks of training
Pannexin channel distribution is assessed immunohistochemically in muscle samples
Before and after 8 weeks of training
Sympathetic activity
Time Frame: Before and after 8 weeks of training
Direct measurement of Muscle Sympathetic Nervous Activity via microneurography
Before and after 8 weeks of training
Vascular function
Time Frame: Before and after 8 weeks of training
Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances
Before and after 8 weeks of training
Mitochondrial function in endothelial cells
Time Frame: Before and after 8 weeks of training
Endothelial cell mitochondrial respiration is measured by High Resolution Respirometry
Before and after 8 weeks of training
Reactive oxygen species formation in in endothelial cells
Time Frame: Before and after 8 weeks of training
Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry
Before and after 8 weeks of training
Rheology
Time Frame: Before and after 8 weeks of training
Platelet rheology. The viscoelastic measurements are based on attainment of the Gel Point (GP) from which the fractal dimension, df, is determined.
Before and after 8 weeks of training
Platelet reactivity
Time Frame: Before and after 8 weeks of training
Platelet reactivity is assessed by multiplate aggregometry
Before and after 8 weeks of training
Maximal oxygen uptake
Time Frame: Before and after 8 weeks of training
Direct Measurement of oxygen uptake during a graded test on cycle ergometer
Before and after 8 weeks of training
Body Composition
Time Frame: Before and after 8 weeks of training
Measured by Dual energy x-ray absorptiometry
Before and after 8 weeks of training
Endothelial cell characterization
Time Frame: Before and after 8 weeks of training
Assessment of protein and mRNA-levels of proteins of relevance for endothelial function
Before and after 8 weeks of training
Skeletal muscle characterization
Time Frame: Before and after 8 weeks of training
Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function
Before and after 8 weeks of training

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Copenhagen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Lundbeck Foundation
Danish Council for Independent Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 19, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2022

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PANX-HYP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently awaiting instructions on this issue from the department

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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