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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01105637
Recruitment Status : Completed
First Posted : April 16, 2010
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Deconditioning Among Survivors of Severe Burns Behavioral: Augmented Exercise Program

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
Study Start Date : July 2007
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Exercise Behavioral: Augmented Exercise Program
12 week (3 x per week) exercise prescription


Outcome Measures

Primary Outcome Measures :
  1. Maximal Oxygen Consumption (VO2 max) [ Time Frame: 2 Years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105637


Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Barbara J de Lateur, MD Johns Hopkins Univeristy School of Medicine
More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01105637     History of Changes
Other Study ID Numbers: HBV02-11-15-05
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: June 2016

Keywords provided by Johns Hopkins University:
burn injuries
exercise

Additional relevant MeSH terms:
Burns
Wounds and Injuries