Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Primary Purpose
Congestive Heart Failure, Endothelium-derived Factors, Elderly
Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Passive leg cycle exercise with stretching and resistance training
Stretching and resistance training
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring passive leg exercise, congestive heart failure, endothelium-derived factors, elderly
Eligibility Criteria
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
Sites / Locations
- Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
Passive leg cycle exercise with stretching and resistance training
Stretching and resistance training
Outcomes
Primary Outcome Measures
Endothelial function
Secondary Outcome Measures
Left ventricular systolic and diastolic function
Six-minute walk distance
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00733161
Brief Title
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Official Title
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Endothelium-derived Factors, Elderly
Keywords
passive leg exercise, congestive heart failure, endothelium-derived factors, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Passive leg cycle exercise with stretching and resistance training
Arm Title
2
Arm Type
Active Comparator
Arm Description
Stretching and resistance training
Intervention Type
Other
Intervention Name(s)
Passive leg cycle exercise with stretching and resistance training
Intervention Description
Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training
Intervention Type
Other
Intervention Name(s)
Stretching and resistance training
Intervention Description
Stretching and resistance training everyday but no Passive leg cycle exercise
Primary Outcome Measure Information:
Title
Endothelial function
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Left ventricular systolic and diastolic function
Time Frame
2 weeks
Title
Six-minute walk distance
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takeshi Kimura, MD, PhD
Organizational Affiliation
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
City
Kyoto
ZIP/Postal Code
606-8507
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
22664754
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
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