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CompletedNCT00733161Updated Oct 4, 2023

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

A Phase 4 interventional study of Passive leg cycle exercise with stretching and resistance training and Stretching and resistance training in Congestive Heart Failure, Endothelium-derived Factors and Elderly, sponsored by Kyoto University. Completed at 1 site in Japan. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2023-10-04.

Sponsored by Kyoto University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Congestive Heart Failure
  • Endothelium-derived Factors
  • Elderly

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Keywords

  • passive leg exercise
  • congestive heart failure
  • endothelium-derived factors
  • elderly
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 3,733 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Kyoto University is the lead sponsor of 20 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    1

    Passive leg cycle exercise with stretching and resistance training

    Other: Passive leg cycle exercise with stretching and resistance training

  • Active comparator
    2

    Stretching and resistance training

    Other: Stretching and resistance training

Interventions

  • OtherPassive leg cycle exercise with stretching and resistance training

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

  • OtherStretching and resistance training

    Stretching and resistance training everyday but no Passive leg cycle exercise

06

What researchers measure

Primary outcomes

  1. Endothelial function

    Time frame: 2 weeks

Secondary outcomes

  1. Left ventricular systolic and diastolic function

    Time frame: 2 weeks

  2. Six-minute walk distance

    Time frame: 2 weeks

07

Study locations

1 site
  • Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
    Kyoto, 606-8507, Japan
08

References and documents

Publications

  • 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. PubMed 22664754 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00733161
Lead sponsor
Kyoto University
Responsible party
Takeshi Morimoto (Investigator, Kyoto University) — Principal investigator
First posted
Aug 12, 2008
Start date
Aug 2008
Primary completion
Mar 2010
Completion
Mar 2010
Last update
Oct 4, 2023

Study contacts

Takeshi Kimura, MD, PhD
principal investigator · Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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