Aquatic Training in Patients With Severe Scarring

Not Applicable

Withdrawn

• Conditions: Burns; Scar
• Interventions: Other: Aquatic training

• Registration Number: NCT01433198
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Study Timeline

• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-13
• Study Start: 2018-05
• Primary Completion: 2019-05
• Status Verified: 2020-11
• Study Completion: 2020-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aquatic exercise group	Aquatic training	-

Primary Outcome Measures

Name	Time	Method
Change in physical activity using Dynaport activity monitor	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.

Secondary Outcome Measures

Name	Time	Method
Exercise capacity (6-minutes walking test and 4-minutes swimming test)	Baseline, after 6 weeks and after 3 months	Exercise capacity (6-minutes walking test and 4-minutes swimming test)
Joint mobility	Baseline, after 6 weeks, after 3 months	Joint mobility
Strength (Jamar, MicroFET, MIP)	Post-hospitalisation status, basline, after 6 weeks, after 3 months	Strength (Jamar, MicroFET, MIP)
Quality of life (using 5 questionnaires like SF-36)	Basline, after 6 weeks, after 3 months	Quality of life (using 5 questionnaires like SF-36)
BMI	Post-hospitalisation status, baseline, after 6 weeks and after 3 months	BMI
Pulmonary function (FEV1 and FVC)	Post-hospitalisation status, baseline, after 6 weeks, after 3 months	Pulmonary function (FEV1 and FVC)
Scar assessment	Baseline, after 6 weeks, after 3 months	Scar assessment
Physical fitness using Squash questionnaire	Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year	Physical fitness using Squash questionnaire