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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00934609
Other study ID # 2000-01SaarlandU
Secondary ID
Status Completed
Phase N/A
First received July 7, 2009
Last updated September 17, 2009

Study information

Verified date September 2009
Source Saarland University
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial Summary

The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure


Recruitment information / eligibility

Status Completed
Enrollment 66
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- chronic heart failure NYHA stage 2 and 3

Exclusion Criteria:

- Valvular disease

- recent decompensation

- Other complaints that might interfere with ergometer exercise

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Endurance training
45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks

Locations

Country Name City State
Germany Institute of Sports- and Preventive Medicine, Saarland University Saarbrücken Saarland

Sponsors (2)

Lead Sponsor Collaborator
Saarland University The German Heart Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Physical capacity No
Secondary Left ventricular function No
Secondary occurence of complications within study period Yes
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