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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Withdrawn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
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Burns

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 1, 2011
    Last Updated
    November 23, 2020
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    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    Withdrawn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

    Learn more about this trial

    Aquatic Training in Patients With Severe Scarring

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