BedrestNCT00598494
Effect of Bedrest With and Without Exercise on the Heart
An observational study of Bedrest, run by The Cleveland Clinic at 1 site in United States.
Trial summary
The purpose of this research sub-study is to determine the changes in heart function during the bedrest period using ultrasound and MRI. This topic is important for medical care of astronauts in space. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bedrest
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jul 2008
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Normal volunteers
Who may be able to join
- age 18 or older
- Currently participating in bed rest study
Who cannot join
- -unable to maintain bedrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Bedrest With and Without Exercise on Cardiac Atrophy: Synergistic Supplemental Testing With the Cleveland Clinic Bedrest Study
The purpose of this research sub-study is to determine the changes in heart function during the bedrest period using ultrasound and MRI. This topic is important for medical care of astronauts in space. It can enable physicians on the ground to monitor exercise protocols that are used to prevent deconditioning-loss of strength during long space flights.
Your participation in this study would include ultrasound examinations with bicycle exercise before, during, and after the 12-week bedrest period. MRI exams would be performed before and after the bedrest period.
Read more
Each echo exam may last up to 1 hour. This time will be required to perform an ultrasound examination before and during supine (lying down) bicycle exercise. The exercise period will be approximately 10-15 minutes. The bicycle exercise will be a symptom-limited test. This means that the test will be stopped if you experience any discomfort. An ultrasound examination of your heart will be done to assess heart function. You will be asked to lie on your left side on an examination table while a technician takes pictures of your heart with a small probe that is gently pressed against your chest after applying a gel. The ultrasound data will be processed to evaluate myocardial strain, a value that may be useful in describing heart function.
Each MRI may last up to 1 hour. An MRI obtains body pictures created by using magnetic energy rather than x-ray energy. To have the scan, you will lie on a table that slides into the scanner, which is like a large tube. An MRI examination of your heart will be done to assess heart function. You will be asked to lie still and follow simple breathing instructions during the procedure. The MRI data will be processed to evaluate the volume of blood being pumped by your heart, a value that may be useful in describing heart function.
Read the detailed description
NASA and NSBRI are making considerable investment in a bedrest study being conducted at the Cleveland Clinic Foundation under the directorship of Peter Cavanaugh, primarily to assess the impact of exercise on prevention of osteoporosis in a twelve-week bedrest study to simulate microgravity. This provides an outstanding opportunity for synergistic add-on studies to combine the resources of the bone team of NSBRI with those of the Cardiovascular Alterations and Smart Medicine by conducting a series of detailed echocardiographic and computed tomographic examinations of the heart in these patients. These studies will serve to advance a number of the specific aims of a grant currently held by James D. Thomas from NSBRI concerning both the primary effects of microgravity on the heart and its reversal with exercise as well as the ability to prove out new echocardiographic methods for measuring the cardiac response to exercise. Finally, they will provide an excellent opportunity to prove out methodologies being developed for remote delivery of healthcare by image fusion from free-flight studies to in-flight echoes.
We will to pursue the following specific aims with this synergistic study:
Specific Aim 1: To assess the impact of bedrest on cardiac atrophy, stiffening of the left ventricular diastolic pressure volume curve, and exercise tolerance and ventricular mechanics and demonstrate at least partial prevention of these changes with the proposed exercise prescription.
Specific Aim 2: To demonstrate the ability of novel echocardiographic indices of ventricular function (strain, torsion, IVPG) to predict functional capacity and response to exercise.
Specific Aim 3: To test whether pre-bedrest MRI examinations could be co-registered with bedrest 3D echocardiographic exams to track atrophy and altered cardiac anatomy. The ability of detailed 3D ground examinations to be compared precisely with in-flight 3D echos is a key goal of autonomous medical care system for expedition class missions.
Proposed Protocol (summary):
Pre-bedrest (within 1-3 weeks prior):
- Resting two and three-dimensional echocardiogram.
- Maximal supine bicycle test with echocardiographic assessment of wall motion, tissue strain, tissue torsion, and intraventricular pressure gradients (IVPG) by color M-mode flow propagation. In addition to the peak exercise assessment, we will also focus on the submaximal level (heart rate ~100).
- MRI examination of the heart for LV volume and mass and subsequent cross registration with echocardiogram.
Six weeks of bedrest:
- Resting two and three-dimensional echo exam.
- Low-level supine bicycle exercise echo (HR no greater than 100) with torsion, strain, and IVPG assessment.
Twelve weeks of bedrest:
- Resting two and three-dimensional echo.
- Maximal supine bicycle test with echocardiographic assessment of wall motion, tissue strain, tissue torsion, and IVPG.
- MRI examination of the heart.
As part of the overall bedrest protocol (IRB 6504), patients will be randomized either to complete bedrest with negative tilt vs. those who will undergo daily horizontal treadmill exercise to replace the calcaneus impact measured pre-bedrest in the same subjects. This provides an excellent opportunity for assessing the impact of this degree in type of exercise on the cardiovascular system.
The specific aims of this synergistic study will be answered as follows:
Specific Aim 1: To assess the impact of bedrest on cardiac atrophy, stiffening of the left ventricular diastolic pressure volume curve, and exercise tolerance and ventricular mechanics and demonstrate at least partial prevention of these changes with the proposed exercise prescription.
LV mass will be measured by MRI pre- and post-bedrest and by 3D echo at bedrest stages. Two-way linear regression will be used to determine change over time in LV mass and to compare the response to exercise. Similarly, exercise capacity will be analyzed. Among the LV mechanics parameters that will be available for analysis at all 3 data acquisition points are: (resting) LV end-diastolic and end-systolic volume, left atrial volume, transmitral E and A waves and E-wave deceleration time, Doppler tissue annular E, A, and S waves, radial, circumferential, and longitudinal strain at the midventricular level, LV torsion and peak untwisting rate, and color M-mode IVPG. These same parameters will also be available for analysis during low-level (HR 100) bicycle exercise.
Specific Aim 2: To demonstrate the ability of novel echocardiographic indices of ventricular function at rest (strain, torsion, IVPG) to predict functional capacity and response to exercise.
Strain, torsion, and IVPG will be assessed at all stages and correlated with changes in cardiac atrophy parameters (LV mass and volumes).
Specific Aim 3: To test whether pre/post bedrest MRI examinations can be co-registered with bedrest 3D echocardiographic exams to track atrophy and altered cardiac anatomy. The ability of detailed 3D ground examinations to be compared precisely with in-flight 3D echos is a key goal of autonomous medical care system for expedition class missions.
- Conditions
- Bedrest
- Keywords
- effect of bedrest, cardiac atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
2D and 3D echocardiography
Measured: 12 weeks
Secondary outcomes (1)
MRI
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startFeb 2007
- Primary completionJul 2008
- Study completionJul 2008
Why it stopped: Main bedrest study moved to Texas. No enrollment at Cleveland Clinic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BedrestStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Responsible party
- Sponsor
- Investigators
- Jim Thomas, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598494
- Sponsor's protocol ID
- 07-007
- Other IDs
- SMS00404
- Status last verified
- Jan 2017
- First submitted
- 26 Dec 2007
- Last updated
- 27 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bedrest With and Without Exercise on Cardiac Atrophy: Synergistic Supplemental Testing With the Cleveland Clinic Bedrest Study
- ClinicalTrials.gov ID
- NCT00598494
- Acronym / sponsor ID
- 07-007
- Conditions
- Bedrest
- Keywords
- effect of bedrest, cardiac atrophy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Main bedrest study moved to Texas. No enrollment at Cleveland Clinic.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Space Biomedical Research Institute
- Study start
- Feb 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 22 Jan 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 research sub-study is to determine the changes in heart function during the bedrest period using ultrasound and MRI. This topic is important for medical care of astronauts in space. It can enable physicians on the ground to monitor exercise protocols that are used to prevent deconditioning-loss of strength during long space flights.
Your participation in this study would include ultrasound examinations with bicycle exercise before, during, and after the 12-week bedrest period. MRI exams would be performed before and after the bedrest period.
Each echo exam may last up to 1 hour. This time will be required to perform an ultrasound examination before and during supine (lying down) bicycle exercise. The exercise period will be approximately 10-15 minutes. The bicycle exercise will be a symptom-limited test. This means that the test will be stopped if you experience any discomfort. An ultrasound examination of your heart will be done to assess heart function. You will be asked to lie on your left side on an examination table while a technician takes pictures of your heart with a small probe that is gently pressed against your chest after applying a gel. The ultrasound data will be processed to evaluate myocardial strain, a value that may be useful in describing heart function.
Each MRI may last up to 1 hour. An MRI obtains body pictures created by using magnetic energy rather than x-ray energy. To have the scan, you will lie on a table that slides into the scanner, which is like a large tube. An MRI examination of your heart will be done to assess heart function. You will be asked to lie still and follow simple breathing instructions during the procedure. The MRI data will be processed to evaluate the volume of blood being pumped by your heart, a value that may be useful in describing heart function.
Detailed description
NASA and NSBRI are making considerable investment in a bedrest study being conducted at the Cleveland Clinic Foundation under the directorship of Peter Cavanaugh, primarily to assess the impact of exercise on prevention of osteoporosis in a twelve-week bedrest study to simulate microgravity. This provides an outstanding opportunity for synergistic add-on studies to combine the resources of the bone team of NSBRI with those of the Cardiovascular Alterations and Smart Medicine by conducting a series of detailed echocardiographic and computed tomographic examinations of the heart in these patients. These studies will serve to advance a number of the specific aims of a grant currently held by James D. Thomas from NSBRI concerning both the primary effects of microgravity on the heart and its reversal with exercise as well as the ability to prove out new echocardiographic methods for measuring the cardiac response to exercise. Finally, they will provide an excellent opportunity to prove out methodologies being developed for remote delivery of healthcare by image fusion from free-flight studies to in-flight echoes.
We will to pursue the following specific aims with this synergistic study:
Specific Aim 1: To assess the impact of bedrest on cardiac atrophy, stiffening of the left ventricular diastolic pressure volume curve, and exercise tolerance and ventricular mechanics and demonstrate at least partial prevention of these changes with the proposed exercise prescription.
Specific Aim 2: To demonstrate the ability of novel echocardiographic indices of ventricular function (strain, torsion, IVPG) to predict functional capacity and response to exercise.
Specific Aim 3: To test whether pre-bedrest MRI examinations could be co-registered with bedrest 3D echocardiographic exams to track atrophy and altered cardiac anatomy. The ability of detailed 3D ground examinations to be compared precisely with in-flight 3D echos is a key goal of autonomous medical care system for expedition class missions.
Proposed Protocol (summary):
Pre-bedrest (within 1-3 weeks prior):
- Resting two and three-dimensional echocardiogram.
- Maximal supine bicycle test with echocardiographic assessment of wall motion, tissue strain, tissue torsion, and intraventricular pressure gradients (IVPG) by color M-mode flow propagation. In addition to the peak exercise assessment, we will also focus on the submaximal level (heart rate ~100).
- MRI examination of the heart for LV volume and mass and subsequent cross registration with echocardiogram.
Six weeks of bedrest:
- Resting two and three-dimensional echo exam.
- Low-level supine bicycle exercise echo (HR no greater than 100) with torsion, strain, and IVPG assessment.
Twelve weeks of bedrest:
- Resting two and three-dimensional echo.
- Maximal supine bicycle test with echocardiographic assessment of wall motion, tissue strain, tissue torsion, and IVPG.
- MRI examination of the heart.
As part of the overall bedrest protocol (IRB 6504), patients will be randomized either to complete bedrest with negative tilt vs. those who will undergo daily horizontal treadmill exercise to replace the calcaneus impact measured pre-bedrest in the same subjects. This provides an excellent opportunity for assessing the impact of this degree in type of exercise on the cardiovascular system.
The specific aims of this synergistic study will be answered as follows:
Specific Aim 1: To assess the impact of bedrest on cardiac atrophy, stiffening of the left ventricular diastolic pressure volume curve, and exercise tolerance and ventricular mechanics and demonstrate at least partial prevention of these changes with the proposed exercise prescription.
LV mass will be measured by MRI pre- and post-bedrest and by 3D echo at bedrest stages. Two-way linear regression will be used to determine change over time in LV mass and to compare the response to exercise. Similarly, exercise capacity will be analyzed. Among the LV mechanics parameters that will be available for analysis at all 3 data acquisition points are: (resting) LV end-diastolic and end-systolic volume, left atrial volume, transmitral E and A waves and E-wave deceleration time, Doppler tissue annular E, A, and S waves, radial, circumferential, and longitudinal strain at the midventricular level, LV torsion and peak untwisting rate, and color M-mode IVPG. These same parameters will also be available for analysis during low-level (HR 100) bicycle exercise.
Specific Aim 2: To demonstrate the ability of novel echocardiographic indices of ventricular function at rest (strain, torsion, IVPG) to predict functional capacity and response to exercise.
Strain, torsion, and IVPG will be assessed at all stages and correlated with changes in cardiac atrophy parameters (LV mass and volumes).
Specific Aim 3: To test whether pre/post bedrest MRI examinations can be co-registered with bedrest 3D echocardiographic exams to track atrophy and altered cardiac anatomy. The ability of detailed 3D ground examinations to be compared precisely with in-flight 3D echos is a key goal of autonomous medical care system for expedition class missions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Normal volunteers
Key inclusion criteria (2 listed)
- age 18 or older
- Currently participating in bed rest study
Key exclusion criteria (1 listed)
- -unable to maintain bedrest
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
2D and 3D echocardiography
Time frame: 12 weeks
1 secondary outcome
MRI
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Main bedrest study moved to Texas. No enrollment at Cleveland Clinic.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Individual participant dataSharing planned: No
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BRAHMS: Bed Rest And HypoMetabolism Study
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Physical Activity in Bed Rest Hospitalized High-Risk Pregnant Women.
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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.
Jim Thomas, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bedrest, run by The Cleveland Clinic 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 Jan 2017. 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 stopped early (reason given: Main bedrest study moved to Texas. No enrollment at Cleveland Clinic.). Results are not available in the source record.
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?
2D and 3D echocardiography (time frame: 12 weeks). 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 27 Jan 2017.