Deconditioning Among Survivors of Severe BurnsAEPNCT01105637
A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
A study testing Augmented Exercise Program in people with Deconditioning Among Survivors of Severe Burns, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Deconditioning Among Survivors of Severe Burns
- What is being tested?
- Augmented Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate
Who cannot join
- History of heart-related health problems
- Foot burns
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
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.
- Being tested
- Augmented Exercise Program
- Keywords
- burn injuries, exercise
- Medical subject headings
- Burns, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Exercise ProgramBehavioural
12 week (3 x per week) exercise prescription
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Other | Not described Receives: Behavioral: Augmented Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen Consumption (VO2 max)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2010 (estimated)
- Study startJul 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Deconditioning Among Survivors of Severe BurnsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara J de Lateur, MD, Principal investigator, Johns Hopkins Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105637
- Sponsor's protocol ID
- HBV02-11-15-05
- Acronym
- AEP
- Status last verified
- Jun 2016
- First submitted
- 12 Apr 2010
- Last updated
- 23 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.apmr.2007.09.003.
PubMed 18036976
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of an Augmented Exercise Program in the Prevention of Deconditioning Among Survivors of Severe Burns
- ClinicalTrials.gov ID
- NCT01105637
- Acronym / sponsor ID
- AEP / HBV02-11-15-05
- Keywords
- burn injuries, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Other | Behavioral: Augmented Exercise Program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who recently suffered a burn injury and who were discharged from the hospital in the past six months may be eligible to participate
Key exclusion criteria (2 listed)
- History of heart-related health problems
- Foot burns
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented Exercise Program12 week (3 x per week) exercise prescription | Behavioural | Exercise |
Primary outcome
Maximal Oxygen Consumption (VO2 max)
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
- Background: PubMed 18036976de 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara J de Lateur, MD principal investigator
Johns Hopkins Univeristy School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Exercise Program in people with Deconditioning Among Survivors of Severe Burns, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Oxygen Consumption (VO2 max) (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105637, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016; AzTrials last refreshed its copy on 30 Oct 2026.