NCT00315224

Brief Summary

The present work examines the impact of pulse pressure as a footprint of vascular ageing on cardiovascular benefits of endurance training in elderly hypertensives. METHODS AND RESULTS: 54 patients ≥ 60 years with antihypertensive treatment and diastolic 24h-ambulatory blood pressure (ABP) ≤ 90 mmHg are randomly assigned to sedentary activity or a heart-rate controlled 12 week exercise program, consisting of walking on a treadmill at target lactate concentrations of 2.5 ± 0.5 mmol/l. 24h-ambulatory blood pressure, physical performance, arterial elasticity, endothelium-derived vasodilation, quality of life, and weight are assessed at baseline and follow-up.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Feb 2005

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

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

February 1, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 14, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 18, 2006

Completed
Last Updated

April 18, 2006

Status Verified

March 1, 2005

First QC Date

April 14, 2006

Last Update Submit

April 14, 2006

Conditions

Hypertension

Keywords

Isolated systolic Hypertensionexercisepulse pressureendothelium

Outcome Measures

Primary Outcomes (1)

  • Decrease of 24h-ambulatory systolic blood pressure

Secondary Outcomes (4)

  • change of diastolic blood pressure

  • change of pulse pressure

  • change of arterial compliance

  • change of endothelium-derived vasodilation

Interventions

heart-rate controlled 12 week exercise programBEHAVIORAL

Eligibility Criteria

Age61 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 60 years antihypertensive treatment diastolic 24h-ambulatory blood pressure (ABP) ≤ 90 mmHg

You may not qualify if:

  • regular engagement in physical exercise training in the past 12 weeks symptomatic peripheral arterial occlusive disease aortic insufficiency or stenosis \> stage I hypertrophic obstructive cardiomyopathy (HOCM) congestive heart failure (\> NYHA II) uncontrolled cardiac arrhythmia with haemodynamic relevance systolic office BP ≥ 180 mmHg signs of acute ischemia in exercise ECG change of antihypertensive medication in the past 6 weeks or during follow-up period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité, Campus Benjamin Franklin

Berlin, 12200, Germany

Location

MeSH Terms

Conditions

HypertensionIsolated Systolic HypertensionMotor Activity

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesEssential HypertensionBehavior

Study Officials

  • Timm H Westhoff, MD

    Charité, Campus Benjamin Franklin, Medizinische Klinik IV, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 14, 2006

First Posted

April 18, 2006

Study Start

February 1, 2005

Study Completion

October 1, 2005

Last Updated

April 18, 2006

Record last verified: 2005-03

Locations

DE(1)