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NCT00733161 Clinical Trial

Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure

Congestive Heart Failure Clinical Trial

Official title:
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00733161
Other study ID # 20795203
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date August 2008
Est. completion date March 2010

Study information
Verified date October 2023
Source Kyoto University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.

Description:

Endothelial function is known to be impaired in patients with chronic heart failure (CHF) and impaired endothelial function has been reported to be associated with an increased mortality risk in those subjects. Although systemic exercise training has been demonstrated to improve endothelial dysfunction in patients with CHF, elderly patients with severely impaired exercise capacity could not engaged in usual exercise training using ordinal ergometer. Those patients are able to join stretching or very light resistance training. On the other hand, passive pedaling using strength ergometer has been reported to be useful in patients with severely impaired exercise capacity, but the safety and the efficacy of passive pedaling on endothelial function in old patients with CHF has not been previously reported.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Clinical diagnosis of chronic heart failure - Elderly patients aged ?65 years - Patients with severely reduced exercise capacity and cannot continue exercise with usual cycling ergometer for 5 minutes Exclusion Criteria: - Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension) - Active infectious disease - Malignancy - Chronic obstructive pulmonary disease - Dialysis - Severe aortic valve disease - With any hip, knee, ankle joint pain - Hemiplegia - Current smoker

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Passive leg cycle exercise with stretching and resistance training
Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training
• Stretching and resistance training
Stretching and resistance training everyday but no Passive leg cycle exercise

Locations
Country Name City State
Japan Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine Kyoto

Sponsors (1)
Lead Sponsor Collaborator
Kyoto University

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Endothelial function 2 weeks
Secondary Left ventricular systolic and diastolic function 2 weeks
Secondary Six-minute walk distance 2 weeks
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