Effect of Bedrest With and Without Exercise on the Heart (NSBRI #4)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by The Cleveland Clinic.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Space Biomedical Research Institute
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00598494
First received: December 26, 2007
Last updated: January 21, 2008
Last verified: January 2008
  Purpose

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.


Condition
Bedrest

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Bedrest With and Without Exercise on Cardiac Atrophy: Synergistic Supplemental Testing With the Cleveland Clinic Bedrest Study

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • 2D and 3D echocardiography [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MRI [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: February 2007
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Normal volunteers

Criteria

Inclusion Criteria:

  • Subjects enrolled in "A Quantitative Test of On-Orbit Exercise Countermeasures for Bone Mineralization Using a Bedrest Analog"
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598494

Contacts
Contact: Christine Whitman, RN 216-445-6916 whitmac@ccf.org
Contact: Donald Holmes, RN 216-445-6397 holmesd@ccf.org

Locations
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christine Whitman, RN    216-445-6916    whitmac@ccf.org   
Contact: Donald Holmes, RN    216-445-6397    holmesd@ccf.org   
Principal Investigator: Jim Thomas, MD         
Sponsors and Collaborators
The Cleveland Clinic
National Space Biomedical Research Institute
Investigators
Principal Investigator: Jim Thomas, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Jim Thomas, MD, Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00598494     History of Changes
Other Study ID Numbers: NSBRI NCC9-59-172 #4, IRB 07-007, NSBRI Bedrest, SMS00404
Study First Received: December 26, 2007
Last Updated: January 21, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
effect of bedrest
cardiac atrophy

ClinicalTrials.gov processed this record on July 23, 2014