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

October 2, 2023 updated by: Takeshi Morimoto, Kyoto University
The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Passive leg cycle exercise with stretching and resistance training
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
Active Comparator: 2
Stretching and resistance training
Other: Stretching and resistance training
Stretching and resistance training everyday but no Passive leg cycle exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endothelial function
Time Frame: 2 weeks
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University

Investigators

  • Principal Investigator: Takeshi Kimura, MD, PhD, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

August 11, 2008

First Submitted That Met QC Criteria

August 11, 2008

First Posted (Estimated)

August 12, 2008

Study Record Updates

Last Update Posted (Actual)

October 4, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20795203

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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