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

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

Detailed Description
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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.

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

Conditions
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Elderly, Congestive Heart Failure, Endothelium-derived Factors

Intervention / Treatment
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* Other: Passive leg cycle exercise with stretching and resistance training
* Other: Stretching and resistance training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Passive leg cycle exercise with stretching and resistance training | Other: Passive leg cycle exercise with stretching and resistance training<br>* Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training<br>|
| Active Comparator: 2<br>Stretching and resistance training | Other: Stretching and resistance training<br>* Stretching and resistance training everyday but no Passive leg cycle exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left ventricular systolic and diastolic function |  | 2 weeks | 
| Six-minute walk distance |  | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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elderly, passive leg exercise, congestive heart failure, endothelium-derived factors