A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns (AEP)

Tracking Information
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; (submitted: April 15, 2010)	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.
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
Condition ICMJE	Deconditioning Among Survivors of Severe Burns
Intervention ICMJE	Behavioral: Augmented Exercise Program; 12 week (3 x per week) exercise prescription
Study Arms	Exercise; Intervention: Behavioral: Augmented Exercise Program
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: June 21, 2016)	20
Original Estimated Enrollment ICMJE; (submitted: April 15, 2010)	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: Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate Exclusion Criteria: History of heart-related health problems; Foot burns
Sex/Gender	Sexes Eligible for Study: All
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	Principal Investigator: Barbara J de Lateur, MD Johns Hopkins Univeristy School of Medicine
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