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

Primary Purpose

Deconditioning Among Survivors of Severe Burns

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Augmented Exercise Program

About this trial

This is an interventional prevention trial for Deconditioning Among Survivors of Severe Burns focused on measuring burn injuries, exercise

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Johns Hopkins Bayview Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Exercise

Arm Description

Outcomes

Primary Outcome Measures

Maximal Oxygen Consumption (VO2 max)

Secondary Outcome Measures

Full Information

NCT ID

NCT01105637

First Posted

April 12, 2010

Last Updated

June 21, 2016

Sponsor

Johns Hopkins University

1. Study Identification

Unique Protocol Identification Number

NCT01105637

Brief Title

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

Acronym

AEP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Johns Hopkins University

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Deconditioning Among Survivors of Severe Burns

Keywords

burn injuries, exercise

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Exercise

Arm Type

Other

Intervention Type

Behavioral

Intervention Name(s)

Augmented Exercise Program

Intervention Description

12 week (3 x per week) exercise prescription

Primary Outcome Measure Information:

Title

Maximal Oxygen Consumption (VO2 max)

Time Frame

2 Years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Barbara J de Lateur, MD

Organizational Affiliation

Johns Hopkins Univeristy School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Johns Hopkins Bayview Medical Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21224

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18036976

Citation

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. doi: 10.1016/j.apmr.2007.09.003.

Results Reference

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

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