BurnsNCT01433198
Aquatic Training in Patients With Severe Scarring
A study testing Aquatic training in people with Burns and Scar, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
Aim: to investigate the effects of an aquatic exercise program in patients with severe scars Patient population: 10 patients of at least 18 years old patients with scars after burns or other severe skin injuries stratification into two groups: an intervention group and a control group Method: 8 patients will… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Aquatic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2018to Dec 2020
- 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
- at least 18 years old
- hospitalisation at the burn unit of at least 14 days
- patients with severe skin damage (like burns, deglovements, necrotic fasciitis, ...)
Who cannot join
- younger than 18 years
- psychiatric history (recommandation of psychiatrist not to participate in the study)
About this study
Aim:
- to investigate the effects of an aquatic exercise program in patients with severe scars
Patient population:
- 10 patients of at least 18 years old
- patients with scars after burns or other severe skin injuries
- stratification into two groups: an intervention group and a control group
Method:
- 8 patients will participate in the aquatic exercise group and 2 patients in the control group
- assessment of physical fitness parameters, scar tissue and psychosocial impact
Hypothesis:
- patients of the aquatic exercise group will recover sooner and better (physically and psychologically) than patients of the control group
Read the detailed description
Intervention:
- during 6 weeks patients will performed an aquatic exercise program (2 to 3 sessions a week)
Assessment:
- T0: post-hospitalisation status: body mass index, physical fitness, strength and respiratory function
- T1: at baseline: body mass index, physical fitness, strength, respiratory function, exercise capacity, mobility, scar parameters and some questionnaires
- T2: after 6 weeks training: same measurements as T1
- T3: 3 months after end of aquatic training: idem T1
- T4: 6 months after end of aquatic training: questionnaires
- T5: 1 year after end of aquatic training: questionnaires
- Being tested
- Aquatic training
- Medical subject headings
- Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic trainingOther
Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercise group | Active comparator | Not described Receives: Other: Aquatic training |
| Control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physical activity using Dynaport activity monitor
Post-hospitalisation status = participants will be followed during the last three consecutive days of their hospital stay.
The minimum period of hospital stay is 14 days (inclusion criteria), the maximum period of hospital stay is not determined. The expected average can not be given.
Measured: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Secondary outcomes (8)
Strength (Jamar, MicroFET, MIP)
Strength (Jamar, MicroFET, MIP)
Measured: Post-hospitalisation status, basline, after 6 weeks, after 3 months
Quality of life (using 5 questionnaires like SF-36)
Quality of life (using 5 questionnaires like SF-36)
Measured: Basline, after 6 weeks, after 3 months
Exercise capacity (6-minutes walking test and 4-minutes swimming test)
Exercise capacity (6-minutes walking test and 4-minutes swimming test)
Measured: Baseline, after 6 weeks and after 3 months
BMI
BMI
Measured: Post-hospitalisation status, baseline, after 6 weeks and after 3 months
Joint mobility
Joint mobility
Measured: Baseline, after 6 weeks, after 3 months
Pulmonary function (FEV1 and FVC)
Pulmonary function (FEV1 and FVC)
Measured: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Scar assessment
Scar assessment
Measured: Baseline, after 6 weeks, after 3 months
Physical fitness using Squash questionnaire
Physical fitness using Squash questionnaire
Measured: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startMay 2018 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: finances and feasibility
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.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, prof. Eric Van den Kerckhove, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Eric Van den Kerckhove, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433198
- Sponsor's protocol ID
- ML7560
- Status last verified
- Nov 2020
- First submitted
- 1 Sep 2011
- Last updated
- 20 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Training in Patients With Severe Scarring
- ClinicalTrials.gov ID
- NCT01433198
- Acronym / sponsor ID
- ML7560
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: finances and feasibility
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Sep 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.
Aim:
- to investigate the effects of an aquatic exercise program in patients with severe scars
Patient population:
- 10 patients of at least 18 years old
- patients with scars after burns or other severe skin injuries
- stratification into two groups: an intervention group and a control group
Method:
- 8 patients will participate in the aquatic exercise group and 2 patients in the control group
- assessment of physical fitness parameters, scar tissue and psychosocial impact
Hypothesis:
- patients of the aquatic exercise group will recover sooner and better (physically and psychologically) than patients of the control group
Detailed description
Intervention:
- during 6 weeks patients will performed an aquatic exercise program (2 to 3 sessions a week)
Assessment:
- T0: post-hospitalisation status: body mass index, physical fitness, strength and respiratory function
- T1: at baseline: body mass index, physical fitness, strength, respiratory function, exercise capacity, mobility, scar parameters and some questionnaires
- T2: after 6 weeks training: same measurements as T1
- T3: 3 months after end of aquatic training: idem T1
- T4: 6 months after end of aquatic training: questionnaires
- T5: 1 year after end of aquatic training: questionnaires
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercise group | Active comparator | Other: Aquatic training |
| Control group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- at least 18 years old
- hospitalisation at the burn unit of at least 14 days
- patients with severe skin damage (like burns, deglovements, necrotic fasciitis, ...)
Key exclusion criteria (2 listed)
- younger than 18 years
- psychiatric history (recommandation of psychiatrist not to participate in the study)
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 |
|---|---|---|
| Aquatic trainingAquatic training during a 6 weeks program (15 to 18 sessions of 1 hour) | Other | Aquatic exercise group |
Primary outcome
Change in physical activity using Dynaport activity monitor
Time frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Post-hospitalisation status = participants will be followed during the last three consecutive days of their hospital stay. The minimum period of hospital stay is 14 days (inclusion criteria), the maximum period of hospital stay is not determined. The expected average can not be given.
8 secondary outcomes
Strength (Jamar, MicroFET, MIP)
Time frame: Post-hospitalisation status, basline, after 6 weeks, after 3 months
Quality of life (using 5 questionnaires like SF-36)
Time frame: Basline, after 6 weeks, after 3 months
Exercise capacity (6-minutes walking test and 4-minutes swimming test)
Time frame: Baseline, after 6 weeks and after 3 months
BMI
Time frame: Post-hospitalisation status, baseline, after 6 weeks and after 3 months
Joint mobility
Time frame: Baseline, after 6 weeks, after 3 months
Pulmonary function (FEV1 and FVC)
Time frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Scar assessment
Time frame: Baseline, after 6 weeks, after 3 months
Physical fitness using Squash questionnaire
Time frame: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
Related trials for Burns
Not yet recruiting
Effect of Short-Video Distraction During Burn Dressing on Anxiety, Pain, and Fear in Children
Burn Injury, Procedural Anxiety
RecruitingObservational study
Early Detection and Kinetics of Sepsis-Induced Coagulopathy in Severe Burn Patients
Peer Bullying Intervention, Vodcast
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
RecruitingPhase 2
Dupixent in Adults With Refractory Post-Burn Pruritus in an Ambulatory Clinic
Pruritis
Recruiting
Efferon LPS Hemoadsorption in in Patients With Thermal Burns
Burns
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.
Eric Van den Kerckhove principal investigator
KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic training in people with Burns and Scar, run by Universitaire Ziekenhuizen KU Leuven.
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 3 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: withdrawn, as of the sponsor's last update on 20 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change in physical activity using Dynaport activity monitor (time frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months). 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 20 Dec 2023.