A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns (AEP)
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ClinicalTrials.gov Identifier: NCT01105637 |
Recruitment Status
:
Completed
First Posted
: April 16, 2010
Last Update Posted
: June 23, 2016
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Tracking Information | ||||
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First Submitted Date ICMJE | April 12, 2010 | |||
First Posted Date ICMJE | April 16, 2010 | |||
Last Update Posted Date | June 23, 2016 | |||
Study Start Date ICMJE | July 2007 | |||
Actual 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 ] | |||
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 Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (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 Arms | Exercise
Intervention: Behavioral: Augmented Exercise Program |
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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. | |||
* 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 | Completed | |||
Actual Enrollment ICMJE |
20 | |||
Original Estimated Enrollment ICMJE |
60 | |||
Actual Study Completion Date | January 2012 | |||
Actual Primary Completion Date | January 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 65 Years (Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
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 | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Johns Hopkins University | |||
Study Sponsor ICMJE | Johns Hopkins University | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Johns Hopkins University | |||
Verification Date | June 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |