NCT01433198撤回不适用
Aquatic Training in Patients With Severe Scarring
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Change in physical activity using Dynaport activity monitor
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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, ...)
排除标准
- •younger than 18 years
- •psychiatric history (recommandation of psychiatrist not to participate in the study)
结局指标
主要结局
Change in physical activity using Dynaport activity monitor
时间窗: 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.
次要结局
- Exercise capacity (6-minutes walking test and 4-minutes swimming test)(Baseline, after 6 weeks and after 3 months)
- Joint mobility(Baseline, after 6 weeks, after 3 months)
- 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)
- BMI(Post-hospitalisation status, baseline, after 6 weeks and after 3 months)
- Pulmonary function (FEV1 and FVC)(Post-hospitalisation status, baseline, after 6 weeks, after 3 months)
- Scar assessment(Baseline, after 6 weeks, after 3 months)
- Physical fitness using Squash questionnaire(Baseline, after 6 weeks, after 3 months, after 6 months, after 1 year)
研究者
prof. Eric Van den Kerckhove
PhD - PT
Universitaire Ziekenhuizen KU Leuven
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