Aquatic Training in Patients With Severe Scarring

NCT01433198 | Withdrawn

• 1 other identifier: ML7560
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Burns; Scar

Outcome Measures

Primary Outcomes (1)

• 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.

  Post-hospitalisation status, baseline, after 6 weeks, after 3 months

Secondary Outcomes (8)

• Strength (Jamar, MicroFET, MIP)

  Post-hospitalisation status, basline, after 6 weeks, after 3 months

• Quality of life (using 5 questionnaires like SF-36)

  Basline, after 6 weeks, after 3 months

• Exercise capacity (6-minutes walking test and 4-minutes swimming test)

  Baseline, after 6 weeks and after 3 months

• BMI

  Post-hospitalisation status, baseline, after 6 weeks and after 3 months

• Joint mobility

  Baseline, after 6 weeks, after 3 months

Study Arms (2)

Aquatic exercise group

ACTIVE COMPARATOR

Other: Aquatic training

Control group

NO INTERVENTION

Interventions

Aquatic training OTHER

Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)

Aquatic exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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, ...)

You may not qualify if:

• younger than 18 years
• psychiatric history (recommandation of psychiatrist not to participate in the study)

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Burns; Cicatrix

Condition Hierarchy (Ancestors)

Wounds and Injuries; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Van den Kerckhove

  KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD - PT

Study Record Dates

• First Submitted: September 1, 2011
• First Posted: September 13, 2011
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2020
• Last Updated: December 20, 2023

Record last verified: 2020-11