Aquatic Training in Patients With Severe Scarring
This study is not yet open for participant recruitment.
Verified September 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
prof. Eric Van den Kerckhove, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01433198
First received: September 1, 2011
Last updated: September 12, 2011
Last verified: September 2011
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Purpose
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
| Condition | Intervention |
|---|---|
|
Burns Scar |
Other: Aquatic training |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Aquatic Training in Patients With Severe Scarring |
Resource links provided by NLM:
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- Change in physical activity using Dynaport activity monitor [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
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.
Secondary Outcome Measures:
- Strength (Jamar, MicroFET, MIP) [ Time Frame: Post-hospitalisation status, basline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
- Quality of life (using 5 questionnaires like SF-36) [ Time Frame: Basline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
- Exercise capacity (6-minutes walking test and 4-minutes swimming test) [ Time Frame: Baseline, after 6 weeks and after 3 months ] [ Designated as safety issue: No ]
- BMI [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks and after 3 months ] [ Designated as safety issue: No ]
- Joint mobility [ Time Frame: Baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
- Pulmonary function (FEV1 and FVC) [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
- Scar assessment [ Time Frame: Baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
- Physical fitness using Squash questionnaire [ Time Frame: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Aquatic exercise group |
Other: Aquatic training
Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)
|
| No Intervention: 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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, ...)
Exclusion Criteria:
- younger than 18 years
- psychiatric history (recommandation of psychiatrist not to participate in the study)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433198
Contacts
| Contact: Mieke Anthonissen | mieke.anthonissen@faber.kuleuven.be |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
| Principal Investigator: | Eric Van den Kerckhove | Katholieke Universiteit Leuven |
More Information
No publications provided
| Responsible Party: | prof. Eric Van den Kerckhove, PhD - PT, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01433198 History of Changes |
| Other Study ID Numbers: | ML7560 |
| Study First Received: | September 1, 2011 |
| Last Updated: | September 12, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Additional relevant MeSH terms:
|
Cicatrix Fibrosis Pathologic Processes |
ClinicalTrials.gov processed this record on May 21, 2013