Congestive Heart FailurePhase 4NCT00733161
Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
A Phase 4 study testing Passive leg cycle exercise with stretching and resistance training and Stretching and resistance training in people with Congestive Heart Failure and Endothelium-derived Factors, run by Kyoto University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Congestive Heart Failure, Endothelium-derived Factors, Elderly
- What is being tested?
- Passive leg cycle exercise with stretching and resistance training and Stretching and resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2008to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension)
- Active infectious disease
- Malignancy
- Chronic obstructive pulmonary disease
- Dialysis
- Severe aortic valve disease
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- With any hip, knee, ankle joint pain
- Hemiplegia
- Current smoker
Trial locations and contacts
1 site in 1 country.
Japan1 site
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
Kyoto, 606-8507
About this study
The purpose of this study is to determine the effect of passive exercise on systemic endothelial function in elderly patients with chronic heart failure.
Read the 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.
- Being tested
- Passive leg cycle exercise with stretching and resistance training, Stretching and resistance training
- Keywords
- passive leg exercise, congestive heart failure, endothelium-derived factors, elderly
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive leg cycle exercise with stretching and resistance trainingOther
Passive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training
Stretching and resistance trainingOther
Stretching and resistance training everyday but no Passive leg cycle exercise
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Passive leg cycle exercise with stretching and resistance training Receives: Other: Passive leg cycle exercise with stretching and resistance training |
| 2 | Active comparator | Stretching and resistance training Receives: Other: Stretching and resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial function
Measured: 2 weeks
Secondary outcomes (2)
Left ventricular systolic and diastolic function
Measured: 2 weeks
Six-minute walk distance
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takeshi Morimoto, Kyoto University
- Investigators
- Takeshi Kimura, MD, PhD, Principal investigator, Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733161
- Sponsor's protocol ID
- 20795203
- Status last verified
- Oct 2023
- First submitted
- 11 Aug 2008
- Last updated
- 4 Oct 2023
- Results posted
- No
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. doi: 10.1253/circj.cj-11-1113. Epub 2012 May 16.
PubMed 22664754
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive Exercise on Systemic Endothelial Function in Elderly Patients With Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT00733161
- Acronym / sponsor ID
- 20795203
- Keywords
- passive leg exercise, congestive heart failure, endothelium-derived factors, elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Passive leg cycle exercise with stretching and resistance trainingPassive leg cycle exercise with stretching and resistance training |
| 2 | Active comparator | Other: Stretching and resistance trainingStretching and resistance training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Unstable hemodynamic status (uncontrolled arrhythmia, uncontrolled congestion, uncontrolled hypertension)
- Active infectious disease
- Malignancy
- Chronic obstructive pulmonary disease
- Dialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Passive leg cycle exercise with stretching and resistance trainingPassive leg cycle exercise for 15 minutes everyday as well as stretching and resistance training | Other | 1 |
| Stretching and resistance trainingStretching and resistance training everyday but no Passive leg cycle exercise | Other | 2 |
Primary outcome
Endothelial function
Time frame: 2 weeks
2 secondary outcomes
Left ventricular systolic and diastolic function
Time frame: 2 weeks
Six-minute walk distance
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
- Derived from this study: PubMed 22664754Ozasa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, MD, PhD principal investigator
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Passive leg cycle exercise with stretching and resistance training and Stretching and resistance training in people with Congestive Heart Failure and Endothelium-derived Factors, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial function (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733161, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.