Effect of Bedrest With and Without Exercise on the Heart

NCT00598494 | Terminated

• 2 other identifiers: 07-007SMS00404
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bedrest

Keywords

effect of bedrest; cardiac atrophy

Outcome Measures

Primary Outcomes (1)

• 2D and 3D echocardiography

  12 weeks

Secondary Outcomes (1)

• MRI

  12 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normal volunteers

You may qualify if:

• age 18 or older
• Currently participating in bed rest study

You may not qualify if:

• unable to maintain bedrest

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Space Biomedical Research Institute: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

• Jim Thomas, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 22, 2008
• Study Start: February 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)