Cardiovascular DiseasesNCT00094250
HEARTS: Heart, Exercise, and Resistance Training Study
A study testing Resistance and Aerobic Training in people with Cardiovascular Diseases and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study is enrolling patients with congestive heart failure (CHF). The goal of the study is to see if one of two carefully monitored exercise programs can improve the ability of these patients to function and get about their activities. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Cardiovascular Diseases, Heart Failure, Congestive, Heart Diseases
- What is being tested?
- Resistance and Aerobic Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Jun 2008
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Class II and III CHF that has been clinically stable for at least 6 months
- Systolic ejection fraction (LVEF) between 20% and 40%
- Under the care of a cardiologist who is willing to have the patient participate in the study and who will continue to follow the patient medically during his/her participation
- Willing and able to undergo the screening procedures and the 1 month observation period to determine eligibility
- Willing and able to come to the research center three times a week for 4 months to participate in an exercise program consisting of either aerobic exercise only, or aerobic exercise plus resistance training
- Able to speak and read English
- Willing to participate in the study after having the study explained to him/her and has signed an informed consent form
Who cannot join
- Eligible for a cardiac rehabilitation program under Medicare rules due to a recent acute event
- Any medical condition that would make either exercise unsafe or uncomfortable, such as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable heart disease, uncontrolled blood pressure, or neurological conditions
- Other complicating diseases, such as severe anemia or other blood dyscrasia affecting function, chronic renal failure, progressive cancer, or unstable diabetes
- Does not otherwise meet the above inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Staten Island University Hospital
Staten Island, New York
About this study
Official title: More Effective Exercise Modalities in Older Congestive Heart Failure Patients
This study is enrolling patients with congestive heart failure (CHF). The goal of the study is to see if one of two carefully monitored exercise programs can improve the ability of these patients to function and get about their activities.
Read the detailed description
BACKGROUND:
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
- If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
- If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
- Being tested
- Resistance and Aerobic Training
- Medical subject headings
- Cardiovascular Diseases, Heart Failure, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and Aerobic TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in work capacity at anaerobic threshold (measured at Month 4)
Secondary outcomes (3)
Improvements in muscle oxidative capacity, as measured by near infrared spectroscopy (NIRS)
Improvements in local muscle blood flow by NIRS and plethysmography
Improvement in arterial endothelial function (all measured at Month 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2004 (estimated)
- Study startJul 2006
- Primary completionJun 2008
- Study completionJun 2008
Why it stopped: Study was closed due to administrative reasons; study did not enroll any participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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 N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Investigators
- Joel Posner, MD, Principal investigator, Chairman of Medicine, Staten Island University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094250
- Sponsor's protocol ID
- 1272
- Other IDs
- R01HL071567
- Status last verified
- Feb 2009
- First submitted
- 15 Oct 2004
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- More Effective Exercise Modalities in Older Congestive Heart Failure Patients
- ClinicalTrials.gov ID
- NCT00094250
- Acronym / sponsor ID
- 1272
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was closed due to administrative reasons; study did not enroll any participants.
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- Jul 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 15 Oct 2004 (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.
This study is enrolling patients with congestive heart failure (CHF). The goal of the study is to see if one of two carefully monitored exercise programs can improve the ability of these patients to function and get about their activities.
Detailed description
BACKGROUND:
The amount of functional skeletal muscle that CHF patients are able to preserve is a major independent predictor of their ability to maintain physical function. Older patients with CHF (who make up the vast majority of CHF patients) are least able to do this. The disease is marked by a loss of aerobic muscle fibers, while aging is marked by a loss of glycolytic muscle fibers. Because the disease may be physiologically different in older CHF patients than in younger ones (due to loss of both muscle types in older CHF patients), they need different therapeutic approaches. Strategy tests aimed at increasing muscle mass through resistance strength training in systolic failure patients have been rare, small, and generally lacking older participants. The studies done among younger CHF patients have shown that both aerobic, and combination aerobic and strength training can increase work capacity, oxidative muscle activity, and glycolytic muscle strength. Additionally, combination training can improve cardiac measures, including LVEF.
DESIGN NARRATIVE:
An estimated 200 participants age 65 and older with Class II and III CHF and LVEF 20% to 40% will be included in this study. Their work capacity will be measured in watts on a cycle ergometer exercise stress test (Time 1). They will be randomized by gender, race, and disease severity into two exercise groups: 1) resistance and aerobic training (RA); and 2) aerobic training (A). Both groups will exercise three times a week for 4 months. At the end of the 4 months of training, the cycle ergometer stress test will be repeated (Time 2). By comparing changes in maximum watts achieved from Time 1 to Time 2 in each group, an assessment can be made of the effectiveness of each exercise program in improving work capacity. Secondarily, measures will be performed and compared of myocardial remodeling, leg strength, and leg muscle oxidative capacity at Time 1 and Time 2. The goal of the study is to determine the following:
- If low resistance frequent repetition resistance training combined with aerobic training increases aerobic work capacity more than pure aerobic training.
- If any improvement in aerobic work capacity is due to changes in muscle fiber composition, local blood flow, arterial endothelial function, or some combination.
The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Class II and III CHF that has been clinically stable for at least 6 months
- Systolic ejection fraction (LVEF) between 20% and 40%
- Under the care of a cardiologist who is willing to have the patient participate in the study and who will continue to follow the patient medically during his/her participation
- Willing and able to undergo the screening procedures and the 1 month observation period to determine eligibility
- Willing and able to come to the research center three times a week for 4 months to participate in an exercise program consisting of either aerobic exercise only, or aerobic exercise plus resistance training
Key exclusion criteria (4 listed)
- Eligible for a cardiac rehabilitation program under Medicare rules due to a recent acute event
- Any medical condition that would make either exercise unsafe or uncomfortable, such as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable heart disease, uncontrolled blood pressure, or neurological conditions
- Other complicating diseases, such as severe anemia or other blood dyscrasia affecting function, chronic renal failure, progressive cancer, or unstable diabetes
- Does not otherwise meet the above inclusion criteria
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 |
|---|---|---|
| Resistance and Aerobic Training | Behavioural | – |
Primary outcome
Improvement in work capacity at anaerobic threshold (measured at Month 4)
3 secondary outcomes
Improvements in muscle oxidative capacity, as measured by near infrared spectroscopy (NIRS)
Improvements in local muscle blood flow by NIRS and plethysmography
Improvement in arterial endothelial function (all measured at Month 4)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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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.
Joel Posner, MD principal investigator
Chairman of Medicine, Staten Island University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance and Aerobic Training in people with Cardiovascular Diseases and Heart Failure, Congestive, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
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 7 inclusion and 4 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: withdrawn, as of the sponsor's last update on 29 Jul 2016. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Improvement in work capacity at anaerobic threshold (measured at Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2016.