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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Johns Hopkins University

ClinicalTrials.gov Identifier:

NCT01105637

First received: April 12, 2010

Last updated: June 21, 2016

Last verified: June 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

April 12, 2010

Last Updated Date

June 21, 2016

Start Date ^ICMJE

July 2007

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: 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

Enrollment ^ICMJE

Completion Date

January 2012

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

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

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