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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Elderly
• Endothelium-derived Factors
• Heart Failure

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