Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Change in State Anxiety by the State Trait Anxiety Inventory - YA Version
研究概览
简要总结
Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.
详细描述
Haematological malignancies have several unpleasant consequences on psychological and physical health. Indeed, an important fatigue and reduction of functional capacities appear. Reduction of functional capacities leads to the reduction of autonomy in Acts of Daily Living (ADL) and impact negatively the global Quality of Life (GQoL). Patients who undergo high dose treatment in protected area have higher risks of functional decline. In addition, hospital stay alone in sterile room favours increase of anxiety and depression.
Health care strategies are going to integrate and use more of support care as APA and relaxation. Regular APA practice leads to maintain and/or improve physical functioning and psychological well-being. Physical Activity ensures to maintain or develop muscular strength and cardio-respiratory capacities that patients loose if they stay inactive during hospital stay. APA practice participates too in regulation of emotional states. Indeed, it favours positive emotions as self-esteem, self-confidence, satisfaction and pleasure. In the order to limit or reduce anxiety level, relaxation provides an effective response. Maintain functional capacities and reduce negatives emotional states participate to reduce fatigue too. Also, APA associated with relaxation seems to be a good effective support care strategy.
The aim of this study is to implement a supervised APA program with entertaining devices as Exergaming and Biofeedback relaxation for patients undergo high dose treatment in protected area.
Exergaming consists on exercise and training through fun or recreative situations.
Biofeedback device is a relaxation tool that gives feedback on functioning of nervous system in real time. The objective is to leads patients to become aware of their body-information to finally, associate them to sensations and more effectively control them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged between 18 and 75 years old
- •Admitted in Intensive Care Unit
- •Informed consent
排除标准
- •Contraindication for physical exercise
- •Inability to understand the French language (written and/or oral)
- •Ongoing involvement in another proprietary research protocol
- •Lack of affiliation to social security
结局指标
主要结局
Change in State Anxiety by the State Trait Anxiety Inventory - YA Version
时间窗: 2 moments: at the beginning and directly at the end of program.
Self-reported questionnaire with 20 items assessed on a 4 points scale
次要结局
- Sit to Stand Test (SST)(twice: at the beginning of the study and at the end: immediately after the APA program)
- Hospital Anxiety and Depression Scale(Once at the inclusion)
- 2min Walk Test (2MWT)(: twice: at the beginning of the study and at the end: immediately after the APA program)
- EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30(Twice: At the beginning of the study and one month after the intervention)
- Multi-Fatigue Inventory_20 items (MFI-20)(Twice: at the beginning of the study and at the end: just before hospital discharge.)
- Evaluation of the acute effect of an adapted physical activity session on the change in state Anxiety by the State Trait Anxiety Inventory - YA Version(Twice at each moment: just before the session and directly after it to obtain the acute effect of the APA Session.)