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CompletedNCT00315224Updated Apr 18, 2006

Sports in Hypertension of the Elderly

An interventional study of heart-rate controlled 12 week exercise program in Hypertension, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 61 Years and older. Per ClinicalTrials.gov, last updated 2006-04-18.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
61 Years and older
Sex
All
01

Study 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.

Read the detailed description

Based on previous studies on sports in hypertension, we expected the intervention to result in a decrease of systolic 24h-ambulatory BP (systolic ABP) of at least 6 mm Hg in the training group with no changes in the control group.16,17 This difference was considered to be clinically relevant. A sample size of 23 in each group has 80% power to detect a difference in means of 6 mmHg assuming that the common standard deviation is 7 mmHg, a baseline systolic ABP of 140 mmHg and a two-sided p\<0.05. We estimated the drop-out rate to be about 15% leading to a sample size of 27 patients per group.

Patients are recruited from our hypertension outpatient clinic. Inclusion criteria are current antihypertensive treatment, diastolic ABP ≤ 90 mmHg, age of ≥ 60 years. Prior to the exercise program, cardiac function is examined by ECG and echocardiogram. Exclusion criteria are regular engagement in physical exercise training in the past 12 weeks prior to inclusion in the study, 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 prior to inclusion in the study or during follow-up period. According to these criteria 54 patients are enrolled and randomized to exercise and control group.

Physical performance is assessed using a modified Bruce-protocol. Arterial elasticity is measured by pulse-wave analysis of the radial artery. Endothelium-dependent vasodilation is assessed sonographically by flow-mediated vasodilation. 24h-ABP monitoring is performed using Spacelabs 90207 monitors. The follow-up BP and vascular measurements of the training group are conducted within 2 days after the last training session.

The training program, consisting of walking on a treadmill according to an interval-training pattern, is carried out 3 times weekly for 12 weeks. If patients miss a training session, the program is prolonged until 36 workouts are carried out. The initial duration of training sessions is 30 minutes. During the first week, training consists of 5 workloads of 3 min; between workloads patients walk with half-speed for 3 min. Exercise duration is gradually increased to 4 x 5 min a day in the second week, 3 x 8 min in the third, 3 x 10 min in the fourth and 2 x 15 min in the fifth week. In the sixth and further weeks, exercise is progressively increased to 30, 32 and 36 min and is carried out without interruption. Training intensity corresponds to the speed necessary to reach a lactate concentration of 2.5 ± 0.5 mmol/l in capillary blood slightly above the aerobic threshold. Heart rate during training is controlled by a heart-rate monitor. As lactate concentration sinks below 2.0 mmol/l or exercise heart rate decreases by more than 5/min as a result of training adaptation, treadmill speed is increased by 0.5 km/h or elevation is increased by 3% to maintain training intensity. We have previously shown that this training protocol leads to a substantial increase of physical performance in short time. During training patients are continuously supervised by a physician.

02

Conditions studied

  • Hypertension

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Keywords

  • Isolated systolic Hypertension
  • exercise
  • pulse pressure
  • endothelium
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's enrollment of 54 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

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

04

Who can participate

Ages eligible
61 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants

Interventions

  • Behavioralheart-rate controlled 12 week exercise program
06

What researchers measure

Primary outcomes

  1. Decrease of 24h-ambulatory systolic blood pressure

Secondary outcomes

  1. change of diastolic blood pressure

  2. change of pulse pressure

  3. change of arterial compliance

  4. change of endothelium-derived vasodilation

07

Study locations

1 site
  • Charité, Campus Benjamin Franklin
    Berlin, 12200, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00315224
Lead sponsor
Charite University, Berlin, Germany
First posted
Apr 18, 2006
Start date
Feb 2005
Completion
Oct 2005
Last update
Apr 18, 2006

Study contacts

Timm H Westhoff, MD
principal investigator · Charité, Campus Benjamin Franklin, Medizinische Klinik IV, Berlin, Germany
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2005. You cannot join it, but the record below documents what was studied.

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