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CompletedNCT02844413Updated Jul 26, 2016

Physical Exercises Influence on Blood Pressure and Arterial Stiffness

A Phase 4 interventional study of aerobic interval training in Arterial Hypertension, sponsored by Jagiellonian University. Completed. Open to participants aged 51 Years to 59 Years. Per ClinicalTrials.gov, last updated 2016-07-26.

Sponsored by Jagiellonian University · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
51 Years to 59 Years
Sex
All
01

Study summary

Regular exercise is recommended as an adjuvant treatment in hypertensive subjects by both European and American guidelines. Crucially, however, there are no precise recommendations on the type of physical exercise and how it should be instituted A relatively short period (5 months) of regular aerobic interval training (AIT), significantly decreased blood pressure, pulse wave velocity, and most applanation tonometry indexes in hypertensive subjects also undertaking pharmacological treatment in our study.

Read the detailed description

Regular physical exercise appears to potentiate the effects of pharmacological treatment for arterial hypertension. As such, regular exercise is recommended as an adjuvant treatment in hypertensive subjects by both European and American guidelines. Crucially, however, there are no precise recommendations on the type of physical exercise and how it should be instituted. Aerobic Interval Training (AIT) is a new and novel type training that appears to be beneficial to patients suffering from various medical conditions. There is a distinct lack of evidence on how it affects arterial hypertension. The aim of this study was to evaluate the influence of a 5 month period of regular AIT on blood pressure, carotid femoral pulse wave velocity (PWV) and applanation tonometry indexes in patients previously treated pharmacologically for mild or moderate arterial hypertension.

The study group consisted of 60 hypertensive subjects (30 males, 30 females) (age 54.45 ± 8.52 years) who had previously undergone at least 2 years of combined anti-hypertensive therapy and who had well controlled hypertension, i.e. below 140/90 mmHg. Their pharmacological treatment did not change during the study period. The study group was randomly divided into 2 subgroups. In the first group (G1), AIT was undertaken for 5 months (40 professional AIT sessions performed two times per week in 50 minute sessions) and followed a specially developed program. The second control group (G2), did not attend any training sessions but received medical advice on how to maintain physical activity as outlined by JNC (Joint National Committee) hypertension guidelines. During the baseline visit and then at five months (final visit), both groups underwent testing for office BP (blood pressure), PWV and applanation tonometry indexes using the SphygmoCor® device and the Complior® device.

02

Conditions studied

  • Arterial Hypertension

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03

In context

Hypertension

6,690 studies on the registry are indexed under Hypertension; 966 are open to participants now.

This study's enrollment of 60 is below the median of 90 across 4,996 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Jagiellonian University is the lead sponsor of 156 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
51 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • subjects who have had previously undergone at least 2 years of combined antihypertensive therapy and who had well controlled hypertension, i.e. below 140/90 mmHg
  • subjects whos pharmacological treatment did not change during the study period

Exclusion criteria

Exclusion Criteria:

  • Secondary hypertension
  • Chronic kidney or liver failure
  • Grade 3 hypertension as defined by European Society of Hypertension 2013
  • Chronic obstructive pulmonary disease
  • The need for the use of 3 antihypertensives
  • Diabetes or other illness affected carbohydrate metabolism
  • Previous myocardial infarction
  • Other serious conditions which might shorten survival time
  • Previous stroke or transient ichemic attack (TIA)
  • Other conditions affecting the locomotor system which would significantly limit the ability to undertake exercise
  • Symptomatic heart failure
  • Lack of informed consent
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    study group

    implementation of aerobic interval training

    Other: aerobic interval training

  • No intervention
    control group

    control group

Interventions

  • Otheraerobic interval training

    In the first group (G1), aerobic interval training (AIT) was undertaken for 5 months (40 professional AIT sessions performed two times per week in 50 minute sessions) and followed a specially developed program. The second control group (G2), did not attend any training sessions but received medical advice on how to maintain physical activity as outlined by JNC hypertension guidelines

    Also known as: AIT

06

What researchers measure

Primary outcomes

  1. Pulse wave velocity augmentation of 1.04 [m/s]

    Time frame: 5 months

Secondary outcomes

  1. systolic blood pressure reduction of 3.9 [mmHg] and diastolic blood pressure reduction of 2.7 [mmHg]

    Time frame: 5 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02844413
Lead sponsor
Jagiellonian University
Responsible party
Tomasz Kameczura (MD, PhD, Jagiellonian University) — Principal investigator
First posted
Jul 26, 2016
Start date
Dec 2015
Primary completion
Dec 2015
Completion
May 2016
Last update
Jul 26, 2016

Study contacts

Tomasz Kameczura, MD, PhD
principal investigator · Jagiellonian University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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