A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns (AEP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Johns Hopkins University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Johns Hopkins University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01105637
First received: April 12, 2010
Last updated: April 15, 2010
Last verified: April 2010
| Tracking Information | |||||||||
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| First Received Date ICMJE | April 12, 2010 | ||||||||
| Last Updated Date | April 15, 2010 | ||||||||
| Start Date ICMJE | July 2007 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Maximal Oxygen Consumption (VO2 max) [ Time Frame: 2 Years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01105637 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns | ||||||||
| Official Title ICMJE | A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns | ||||||||
| Brief Summary | Burn injuries can affect how well you are able to perform daily activities. The reason this study is being done is to find out if aerobic exercise helps burn patients recover function, strength and stamina. Participants will come to Johns Hopkins Bayview Medical Center, Burn Rehabilitation Gym for treadmill exercise sessions 3 days per week for 12 weeks. Participants will be tested for strength and stamina before the start of the 12 week program, at the end of the 12 week program, as well as 6 months, 1 year and 2 years after the end of the 12 week program. Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Deconditioning Among Survivors of Severe Burns | ||||||||
| Intervention ICMJE | Behavioral: Augmented Exercise Program
12 week (3 x per week) exercise prescription |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | de Lateur BJ, Magyar-Russell G, Bresnick MG, Bernier FA, Ober MS, Krabak BJ, Ware L, Hayes MP, Fauerbach JA. Augmented exercise in the treatment of deconditioning from major burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S18-23. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 60 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01105637 | ||||||||
| Other Study ID Numbers ICMJE | HBV02-11-15-05 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Barbara J. de Lateur, Principal Investigator, Johns Hopkins University School of Medicine | ||||||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||||||
| Verification Date | April 2010 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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