Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
| Tracking Information | |||||
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| First Received Date ICMJE | August 11, 2008 | ||||
| Last Updated Date | July 6, 2010 | ||||
| Start Date ICMJE | August 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Endothelial function [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00733161 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure | ||||
| Official Title ICMJE | Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Intervention ICMJE |
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| Study Arm (s) |
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| 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. Epub 2012 May 16. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 30 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Japan | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00733161 | ||||
| Other Study ID Numbers ICMJE | 20795203 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Takeshi Kimura, MD, PhD, Kyoto University Graduate School of Medicine | ||||
| Study Sponsor ICMJE | Kyoto University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kyoto University | ||||
| Verification Date | July 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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