Aquatic Training in Patients With Severe Scarring

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
prof. Eric Van den Kerckhove, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01433198
First received: September 1, 2011
Last updated: September 12, 2011
Last verified: September 2011
  Purpose

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 Intervention
Burns
Scar
Other: Aquatic training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Aquatic Training in Patients With Severe Scarring

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Change in physical activity using Dynaport activity monitor [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]

    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) [ Time Frame: Post-hospitalisation status, basline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
  • Quality of life (using 5 questionnaires like SF-36) [ Time Frame: Basline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
  • Exercise capacity (6-minutes walking test and 4-minutes swimming test) [ Time Frame: Baseline, after 6 weeks and after 3 months ] [ Designated as safety issue: No ]
  • BMI [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks and after 3 months ] [ Designated as safety issue: No ]
  • Joint mobility [ Time Frame: Baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
  • Pulmonary function (FEV1 and FVC) [ Time Frame: Post-hospitalisation status, baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
  • Scar assessment [ Time Frame: Baseline, after 6 weeks, after 3 months ] [ Designated as safety issue: No ]
  • Physical fitness using Squash questionnaire [ Time Frame: Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2011
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433198

Contacts
Contact: Mieke Anthonissen mieke.anthonissen@faber.kuleuven.be

Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Eric Van den Kerckhove Katholieke Universiteit Leuven
  More Information

No publications provided

Responsible Party: prof. Eric Van den Kerckhove, PhD - PT, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01433198     History of Changes
Other Study ID Numbers: ML7560
Study First Received: September 1, 2011
Last Updated: September 12, 2011
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014