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

Phase 4

Completed

• Conditions: Congestive Heart Failure; Endothelium-derived Factors; Elderly
• Interventions: Other: Stretching and resistance training; Other: Passive leg cycle exercise with stretching and resistance training

• Registration Number: NCT00733161
• Lead Sponsor: Kyoto University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-11
• Study First Submitted QC: 2008-08-11
• Study First Posted: 2008-08-12
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Stretching and resistance training	Stretching and resistance training
1	Passive leg cycle exercise with stretching and resistance training	Passive leg cycle exercise with stretching and resistance training

Primary Outcome Measures

Name	Time	Method
Endothelial function	2 weeks

Secondary Outcome Measures

Name	Time	Method
Six-minute walk distance	2 weeks
Left ventricular systolic and diastolic function	2 weeks

Trial Locations

Locations (1)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine; 🇯🇵 Kyoto, Japan