Aquatic Training in Patients With Severe Scarring
Primary Purpose
Burns, Scar
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aquatic training
Sponsored by
About this trial
This is an interventional treatment trial for Burns
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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Aquatic exercise group
Control group
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Strength (Jamar, MicroFET, MIP)
Quality of life (using 5 questionnaires like SF-36)
Exercise capacity (6-minutes walking test and 4-minutes swimming test)
BMI
Joint mobility
Pulmonary function (FEV1 and FVC)
Scar assessment
Physical fitness using Squash questionnaire
Full Information
NCT ID
NCT01433198
First Posted
September 1, 2011
Last Updated
November 23, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01433198
Brief Title
Aquatic Training in Patients With Severe Scarring
Official Title
Aquatic Training in Patients With Severe Scarring
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
finances and feasibility
Study Start Date
May 2018 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns, Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aquatic exercise group
Arm Type
Active Comparator
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Aquatic training
Intervention Description
Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)
Primary Outcome Measure Information:
Title
Change in physical activity using Dynaport activity monitor
Description
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.
Time Frame
Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Secondary Outcome Measure Information:
Title
Strength (Jamar, MicroFET, MIP)
Time Frame
Post-hospitalisation status, basline, after 6 weeks, after 3 months
Title
Quality of life (using 5 questionnaires like SF-36)
Time Frame
Basline, after 6 weeks, after 3 months
Title
Exercise capacity (6-minutes walking test and 4-minutes swimming test)
Time Frame
Baseline, after 6 weeks and after 3 months
Title
BMI
Time Frame
Post-hospitalisation status, baseline, after 6 weeks and after 3 months
Title
Joint mobility
Time Frame
Baseline, after 6 weeks, after 3 months
Title
Pulmonary function (FEV1 and FVC)
Time Frame
Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Title
Scar assessment
Time Frame
Baseline, after 6 weeks, after 3 months
Title
Physical fitness using Squash questionnaire
Time Frame
Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Van den Kerckhove
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Aquatic Training in Patients With Severe Scarring
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