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

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: Completed
• Conditions: Hypertension,Essential
• Intervention / Treatment: Other: Training

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Blood pressure	Changes in systolic and diastolic blood pressure	Before and after 8 weeks of training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pannexin channel function assessed in vivo	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	Pannexin channel distribution is assessed immunohistochemically in muscle samples	Before and after 8 weeks of training
Sympathetic activity	Direct measurement of Muscle Sympathetic Nervous Activity via microneurography	Before and after 8 weeks of training
Vascular function	Vascular conductance measured by ultrasound doppler during infusion of vasoactive substances	Before and after 8 weeks of training
Mitochondrial function in endothelial cells	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	Endothelial cell production of reactive oxygen species is measured by High Resolution Respirometry	Before and after 8 weeks of training
Rheology	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	Platelet reactivity is assessed by multiplate aggregometry	Before and after 8 weeks of training
Maximal oxygen uptake	Direct Measurement of oxygen uptake during a graded test on cycle ergometer	Before and after 8 weeks of training
Body Composition	Measured by Dual energy x-ray absorptiometry	Before and after 8 weeks of training
Endothelial cell characterization	Assessment of protein and mRNA-levels of proteins of relevance for endothelial function	Before and after 8 weeks of training
Skeletal muscle characterization	Assessment of protein and mRNA-levels of proteins of relevance for skeletal muscle function	Before and after 8 weeks of training

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Lundbeck Foundation; Danish Council for Independent Research

Publications and helpful links

General Publications

• Moller S, Hansen CC, Ehlers TS, Tamariz-Ellemann A, Tolborg SAR, Kurell ME, Perez-Gomez J, Patrzalek SS, Maulitz C, Hellsten Y, Gliemann L. Exercise Training Lowers Arterial Blood Pressure Independently of Pannexin 1 in Men with Essential Hypertension. Med Sci Sports Exerc. 2022 Sep 1;54(9):1417-1427. doi: 10.1249/MSS.0000000000002936. Epub 2022 Apr 12.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 19, 2019
• Primary Completion (ACTUAL): November 1, 2022
• Study Completion (ACTUAL): November 1, 2022

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (ACTUAL): December 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Pannexin-1 channel
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID 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