Physical Exercises Influence on Blood Pressure and Arterial Stiffness

NCT ID: NCT02844413

Last Updated: 2016-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-05-31

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.

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.

Conditions

Arterial Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

study group

implementation of aerobic interval training

Group Type: EXPERIMENTAL

aerobic interval training

Intervention Type: OTHER

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

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: OTHER

Other Intervention Names

AIT

Eligibility Criteria

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

• Minimum Eligible Age: 51 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jagiellonian University

OTHER

Sponsor Role: lead

Responsible Party

Tomasz Kameczura

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tomasz Kameczura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Jagiellonian University

Other Identifiers

CMUJ-2015/67

Identifier Type: -

Identifier Source: org_study_id