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

NCT ID: NCT00733161

Last Updated: 2023-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-03-31

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.

Conditions

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Congestive Heart Failure Endothelium-derived Factors Elderly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Passive leg cycle exercise with stretching and resistance training

Group Type ACTIVE_COMPARATOR

Passive leg cycle exercise with stretching and resistance training

Intervention Type OTHER

Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training

2

Stretching and resistance training

Group Type ACTIVE_COMPARATOR

Stretching and resistance training

Intervention Type OTHER

Stretching and resistance training everyday but no Passive leg cycle exercise

Interventions

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Passive leg cycle exercise with stretching and resistance training

Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training

Intervention Type OTHER

Stretching and resistance training

Stretching and resistance training everyday but no Passive leg cycle exercise

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyoto University

OTHER

Sponsor Role lead

Responsible Party

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Takeshi Morimoto

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Takeshi Kimura, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Locations

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Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, , Japan

Site Status

Countries

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Japan

References

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Ozasa N, Morimoto T, Bao B, Shioi T, Kimura T. Effects of machine-assisted cycling on exercise capacity and endothelial function in elderly patients with heart failure. Circ J. 2012;76(8):1889-94. doi: 10.1253/circj.cj-11-1113. Epub 2012 May 16.

Reference Type DERIVED
PMID: 22664754 (View on PubMed)

Other Identifiers

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20795203

Identifier Type: -

Identifier Source: org_study_id

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