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
  Purpose

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


Condition Intervention Phase
Congestive Heart Failure
Endothelium-Derived Factors
Elderly
Other: Passive leg cycle exercise with stretching and resistance training
Other: Stretching and resistance training
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • Endothelial function [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Study Start Date: August 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Passive leg cycle exercise with stretching and resistance training
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
Active Comparator: 2
Stretching and resistance training
Other: Stretching and resistance training
Stretching and resistance training everyday but no Passive leg cycle exercise

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00733161

Locations
Japan
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto, Japan, 606-8507
Sponsors and Collaborators
Kyoto University
Investigators
Principal Investigator: Takeshi Kimura, MD, PhD Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
  More Information

No publications provided by Kyoto University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeshi Kimura, MD, PhD, Kyoto University Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT00733161     History of Changes
Other Study ID Numbers: 20795203
Study First Received: August 11, 2008
Last Updated: July 6, 2010
Health Authority: Japan: Ministry of Education, Culture, Sports, Science and Technology

Keywords provided by Kyoto University:
passive leg exercise
congestive heart failure
endothelium-derived factors
elderly

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 22, 2014