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Aquatic Training in Patients With Severe Scarring

Aquatic Training in Patients With Severe Scarring

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01433198
Enrollment
0
Registered
2011-09-13
Start date
2018-05-31
Completion date
2020-12-31
Last updated
2023-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns, Scar

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

Interventions

Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in physical activity using Dynaport activity monitorPost-hospitalisation status, baseline, after 6 weeks, after 3 monthsPost-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

MeasureTime frameDescription
Strength (Jamar, MicroFET, MIP)Post-hospitalisation status, basline, after 6 weeks, after 3 monthsStrength (Jamar, MicroFET, MIP)
Quality of life (using 5 questionnaires like SF-36)Basline, after 6 weeks, after 3 monthsQuality of life (using 5 questionnaires like SF-36)
Exercise capacity (6-minutes walking test and 4-minutes swimming test)Baseline, after 6 weeks and after 3 monthsExercise capacity (6-minutes walking test and 4-minutes swimming test)
BMIPost-hospitalisation status, baseline, after 6 weeks and after 3 monthsBMI
Joint mobilityBaseline, after 6 weeks, after 3 monthsJoint mobility
Pulmonary function (FEV1 and FVC)Post-hospitalisation status, baseline, after 6 weeks, after 3 monthsPulmonary function (FEV1 and FVC)
Scar assessmentBaseline, after 6 weeks, after 3 monthsScar assessment
Physical fitness using Squash questionnaireBaseline, after 6 weeks, after 3 months, after 6 months, after 1 yearPhysical fitness using Squash questionnaire

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026