Clinical trial NCT01433198: Aquatic Training in Patients With Severe Scarring
Official title: Aquatic Training in Patients With Severe Scarring
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Burns
Scar
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2011-09-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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

Eligibility 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)

Primary outcomes:
measure: Change in physical activity using Dynaport activity monitor
timeFrame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Secondary outcomes:
measure: Strength (Jamar, MicroFET, MIP)
timeFrame: Post-hospitalisation status, basline, after 6 weeks, after 3 months
measure: Quality of life (using 5 questionnaires like SF-36)
timeFrame: Basline, after 6 weeks, after 3 months
measure: Exercise capacity (6-minutes walking test and 4-minutes swimming test)
timeFrame: Baseline, after 6 weeks and after 3 months
measure: BMI
timeFrame: Post-hospitalisation status, baseline, after 6 weeks and after 3 months
measure: Joint mobility
timeFrame: Baseline, after 6 weeks, after 3 months
measure: Pulmonary function (FEV1 and FVC)
timeFrame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months
measure: Scar assessment
timeFrame: Baseline, after 6 weeks, after 3 months
measure: Physical fitness using Squash questionnaire
timeFrame: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Eric Van den Kerckhove
role: PRINCIPAL_INVESTIGATOR
References: