Aquatic Training in Patients With Severe Scarring

Burns Clinical Trial

Official title:

Aquatic Training in Patients With Severe Scarring

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01433198
• Other study ID #: ML7560
• Status: Withdrawn
• Phase: N/A
• Start date: May 2018
• Est. completion date: December 2020

Study information

• Verified date: November 2020
• Source: Universitaire Ziekenhuizen KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Burns
• Cicatrix
• Scar

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen KU Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Strength (Jamar, MicroFET, MIP)	Strength (Jamar, MicroFET, MIP)	Post-hospitalisation status, basline, after 6 weeks, after 3 months
Secondary	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
Secondary	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
Secondary	BMI	BMI	Post-hospitalisation status, baseline, after 6 weeks and after 3 months
Secondary	Joint mobility	Joint mobility	Baseline, after 6 weeks, after 3 months
Secondary	Pulmonary function (FEV1 and FVC)	Pulmonary function (FEV1 and FVC)	Post-hospitalisation status, baseline, after 6 weeks, after 3 months
Secondary	Scar assessment	Scar assessment	Baseline, after 6 weeks, after 3 months
Secondary	Physical fitness using Squash questionnaire	Physical fitness using Squash questionnaire	Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year