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Aquatic Training in Patients With Severe Scarring

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ClinicalTrials.gov Identifier: NCT01433198
Recruitment Status : Withdrawn (finances and feasibility)
First Posted : September 13, 2011
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
prof. Eric Van den Kerckhove, Universitaire Ziekenhuizen 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


Condition or disease Intervention/treatment Phase
Burns Scar Other: Aquatic training Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aquatic Training in Patients With Severe Scarring
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aquatic exercise group Other: Aquatic training
Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)

No Intervention: Control group



Primary Outcome Measures :
  1. Change in physical activity using Dynaport activity monitor [ Time Frame: 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 :
  1. Strength (Jamar, MicroFET, MIP) [ Time Frame: Post-hospitalisation status, basline, after 6 weeks, after 3 months ]
  2. Quality of life (using 5 questionnaires like SF-36) [ Time Frame: Basline, after 6 weeks, after 3 months ]
  3. Exercise capacity (6-minutes walking test and 4-minutes swimming test) [ Time Frame: Baseline, after 6 weeks and after 3 months ]
  4. BMI [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks and after 3 months ]
  5. Joint mobility [ Time Frame: Baseline, after 6 weeks, after 3 months ]
  6. Pulmonary function (FEV1 and FVC) [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months ]
  7. Scar assessment [ Time Frame: Baseline, after 6 weeks, after 3 months ]
  8. Physical fitness using Squash questionnaire [ Time Frame: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433198


Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Eric Van den Kerckhove KU Leuven
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Responsible Party: prof. Eric Van den Kerckhove, PhD - PT, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01433198    
Other Study ID Numbers: ML7560
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cicatrix
Fibrosis
Pathologic Processes