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

This study has been completed.
Sponsor:
Information provided by:
Kyoto University
ClinicalTrials.gov Identifier:
NCT00733161
First received: August 11, 2008
Last updated: July 6, 2010
Last verified: July 2010

August 11, 2008
July 6, 2010
August 2008
March 2010   (final data collection date for primary outcome measure)
Endothelial function [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00733161 on ClinicalTrials.gov Archive Site
  • Left ventricular systolic and diastolic function [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
  • Six-minute walk distance [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure

The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Congestive Heart Failure
  • Endothelium-Derived Factors
  • Elderly
  • 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
  • Other: Stretching and resistance training
    Stretching and resistance training everyday but no Passive leg cycle exercise
  • Active Comparator: 1
    Passive leg cycle exercise with stretching and resistance training
    Intervention: Other: Passive leg cycle exercise with stretching and resistance training
  • Active Comparator: 2
    Stretching and resistance training
    Intervention: Other: Stretching and resistance training
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. Epub 2012 May 16.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
March 2010
March 2010   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00733161
20795203
Not Provided
Takeshi Kimura, MD, PhD, Kyoto University Graduate School of Medicine
Kyoto University
Not Provided
Principal Investigator: Takeshi Kimura, MD, PhD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP