- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02844413
Physical Exercises Influence on Blood Pressure and Arterial Stiffness
The Influence of Regular Aerobic Interval Training on Blood Pressure and Arterial Stiffness Amongst Hypertensive Subjects
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: control group
|
|
Experimental: study group
implementation of aerobic 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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pulse wave velocity augmentation of 1.04 [m/s]
Time Frame: 5 months
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
systolic blood pressure reduction of 3.9 [mmHg] and diastolic blood pressure reduction of 2.7 [mmHg]
Time Frame: 5 months
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tomasz Kameczura, MD, PhD, Jagiellonian University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMUJ-2015/67
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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