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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

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

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Label

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

NCT ID

NCT00733161

First Posted

August 11, 2008

Last Updated

October 2, 2023

Sponsor

Kyoto University

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

Arm Type

Active Comparator

Arm Description

Passive leg cycle exercise with stretching and resistance training

Arm Title

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

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

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

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