Aquatic Training in Patients With Severe Scarring

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

Study Overview

• Status: Withdrawn
• Conditions: Burns; Scar
• Intervention / Treatment: Other: Aquatic training

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

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group
Active Comparator: Aquatic exercise group	Other: Aquatic training; Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength (Jamar, MicroFET, MIP)	Strength (Jamar, MicroFET, MIP)	Post-hospitalisation status, basline, after 6 weeks, after 3 months
Quality of life (using 5 questionnaires like SF-36)	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)	Exercise capacity (6-minutes walking test and 4-minutes swimming test)	Baseline, after 6 weeks and after 3 months
BMI	BMI	Post-hospitalisation status, baseline, after 6 weeks and after 3 months
Joint mobility	Joint mobility	Baseline, after 6 weeks, after 3 months
Pulmonary function (FEV1 and FVC)	Pulmonary function (FEV1 and FVC)	Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Scar assessment	Scar assessment	Baseline, after 6 weeks, after 3 months
Physical fitness using Squash questionnaire	Physical fitness using Squash questionnaire	Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Eric Van den Kerckhove, KU Leuven

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2018
• Primary Completion (Estimated): May 1, 2019
• Study Completion (Estimated): December 1, 2020

Study Registration Dates

• First Submitted: September 1, 2011
• First Submitted That Met QC Criteria: September 12, 2011
• First Posted (Estimated): September 13, 2011

Study Record Updates

• Last Update Posted (Actual): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix
• Other Study ID Numbers: ML7560

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No