BurnsNCT01368367
Exercise Training Post Burn Injury
A study testing Intensive exercise in people with Burns, run by The University of Queensland at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burns
- What is being tested?
- Intensive exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2007to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Burns greater than 20% total body surface area
- 18 years of age and over
- English speaking
- Post final grafting procedure
Who cannot join
- Accompanying anoxic brain injury
- Cardiac disease or injury (American College of Sports medicine ACSM criteria)
- Quadriplegia
- Severe behaviour or cognitive disorders
- Compassionate care only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.
Read the detailed description
Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.
This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.
- Conditions
- Burns
- Being tested
- Intensive exercise
- Keywords
- Burns
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive exerciseOther
Both groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights.
| Study group | Role | What they receive |
|---|---|---|
| Intensive exercise group | Active comparator | Not described Receives: Other: Intensive exercise |
| Stretch exercise only | Placebo comparator | Not described Receives: Other: Intensive exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burns Specific Health Scale - Abbreviated (BSHS-A)
The BSHS-A is an injury specific self reported questionnaire consisting of 80 questions encompassing four primary domains namely physical, psychological, social and general, with reports of good internal consistency, test/ retest reliability and strong convergent validity data.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Secondary outcomes (7)
The modified shuttle walk test (MSWT)
The modified shuttle walk test (MSWT) is an established test of functional exercise capacity. It is an objective measure with 15 incremental levels of both walking and running. Total distance acheived will be recorded.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)
VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the modified shuttle walk test) will be recorded by a portable metabolic monitor (Metalyzer 3B analyser (Cortex:biophysik, GMbH, Germany) Cortex MetaMax 3B).
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Resting heart rate (beats/minute)
Resting heart rate was recorded by a polar heart rate monitor (PE3000, Polar Electro, Kemple, Finland) in beats/minute.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Muscle strength
Muscle Strength - a baseline measure of the quadriceps and latisimuss dorsi muscles will be taken by the one repetition maximum or 1RM. This is the maximum amount of weight one can lift in a single repetition for a given exercise and has been utilized as an outcome measure in subjects post burns.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Grip strength
Grip strength will be measured using a Jamar dynamometer as per the protocol for the American Hand Therapists Society with an average of three measurements taken. This dynamometer is a hydraulic appliance which can measure grip strength in five alternate grip position settings. This has been shown to have good reliability and validity and is considered the gold standard of hand grip measurement.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
QuickDash
The Quick disabilities of the arm, shoulder and hand (QuickDASH)is a self rated questionnaire on upper limb function with good repeatability, validity and responsiveness in burns patients. Sixty percent of the questions relate to overall upper limb disability with the remainder of the optional questions relating to work, sports and musical activities. Lower scores on this scale indicate less disability of the upper limb.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
The Lower Extremity Functional Scale (LEFS)
The Lower Extremity Functional Scale (LEFS) measures disability related to the lower extremities with regard to work, activities of daily living and recreation and has been shown to have sensitivity to change in burns patients and excellent test-retest reliability and construct validity in general patients. Higher scores indicate less disability with a possible total of 80.
Measured: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2011 (estimated)
- Study startDec 2007
- Primary completionNov 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368367
- Sponsor's protocol ID
- ETPB1
- Status last verified
- Nov 2010
- First submitted
- 27 May 2011
- Last updated
- 7 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Exercise Training Post Burn Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01368367
- Acronym / sponsor ID
- ETPB1
- Conditions
- Burns
- Keywords
- Burns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Royal Brisbane and Women's Hospital
- Study start
- Dec 2007
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 7 Jun 2011 (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.
The purpose of this study is to determine whether a high intensity aerobic and resisted exercise program will improve physical, functional and psychological outcomes in patients post burn injury.
Detailed description
Even though immediate and early death from severe thermal injury has reduced over the last twenty years, considerable physical and psychosocial morbidity still persists. While exercise is strongly recommended to assist recovery and overall outcome, there is limited evidence in adults to indicate whether it is effective and/or safe.
This study will investigate the effect of a high intensity aerobic and resisted exercise program exercise program on safety, physical, functional and quality of life measures in adults post burn injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive exercise group | Active comparator | Other: Intensive exercise |
| Stretch exercise only | Placebo comparator | Other: Intensive exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Burns greater than 20% total body surface area
- 18 years of age and over
- English speaking
- Post final grafting procedure
Key exclusion criteria (5 listed)
- Accompanying anoxic brain injury
- Cardiac disease or injury (American College of Sports medicine ACSM criteria)
- Quadriplegia
- Severe behaviour or cognitive disorders
- Compassionate care only
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 |
|---|---|---|
| Intensive exerciseBoth groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights. | Other | Intensive exercise group, Stretch exercise only |
Primary outcome
Burns Specific Health Scale - Abbreviated (BSHS-A)
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
The BSHS-A is an injury specific self reported questionnaire consisting of 80 questions encompassing four primary domains namely physical, psychological, social and general, with reports of good internal consistency, test/ retest reliability and strong convergent validity data.
7 secondary outcomes
The modified shuttle walk test (MSWT)
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
VO2peak (ie the volume of oxygen consumed by the cells at the most intensive level during the exercise test)
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Resting heart rate (beats/minute)
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Muscle strength
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Grip strength
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
QuickDash
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
The Lower Extremity Functional Scale (LEFS)
Time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive exercise in people with Burns, run by The University of Queensland at 1 site in Australia.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Jun 2011. 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 Australia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Burns Specific Health Scale - Abbreviated (BSHS-A) (time frame: Change from baseline to six weeks, change from 6 weeks to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jun 2011.