NCT00733161

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

August 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

1.6 years

First QC Date

August 11, 2008

Last Update Submit

October 2, 2023

Conditions

Keywords

passive leg exercisecongestive heart failureendothelium-derived factorselderly

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    2 weeks

Secondary Outcomes (2)

  • Left ventricular systolic and diastolic function

    2 weeks

  • Six-minute walk distance

    2 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Passive leg cycle exercise with stretching and resistance training

Other: Passive leg cycle exercise with stretching and resistance training

2

ACTIVE COMPARATOR

Stretching and resistance training

Other: Stretching and resistance training

Interventions

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

1

Stretching and resistance training everyday but no Passive leg cycle exercise

2

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Heart Failure

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Takeshi Kimura, MD, PhD

    Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

August 11, 2008

First Posted

August 12, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

October 4, 2023

Record last verified: 2023-10

Locations