NCT02844413

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 12, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 26, 2016

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

July 12, 2016

Last Update Submit

July 21, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pulse wave velocity augmentation of 1.04 [m/s]

    5 months

Secondary Outcomes (1)

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

    5 months

Study Arms (2)

study group

EXPERIMENTAL

implementation of aerobic interval training

Other: aerobic interval training

control group

NO INTERVENTION

control group

Interventions

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
study group

Eligibility Criteria

Age51 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Tomasz Kameczura, MD, PhD

    Jagiellonian University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

July 12, 2016

First Posted

July 26, 2016

Study Start

December 1, 2015

Primary Completion

December 1, 2015

Study Completion

May 1, 2016

Last Updated

July 26, 2016

Record last verified: 2016-07