Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- 6MWT -12 weeks
研究概览
简要总结
Pulmonary sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs.
PS manifest in reduction of pulmonary function. Overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity.
Treatment of sarcoidosis is usually limited to patient symptoms. Progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.
Physical training shows promising evidence of a positive effect on PF. No defined training program with regard to exercise frequency, duration or intensities exists.
PS is a relatively rare disease and patients are scattered in great geographically areas,.It is difficult to organize targeted group training with supervised physical training, convenient for patients and affordable for the public health sector. Tele-rehabilitation (TR) seems to be a good approach to reach patients in low inhabited areas, going from health care to self-care, empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors.
Preliminary evaluations from TR initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model.
No studies on the feasibility effect of TR in PS exists. The study is a prospective randomized controlled trial investigating the effects of tele-rehabilitation in patients with PS compared to standard practice. 24 patients with PS will be randomized in two groups, trained by tele-rehabilitation for 12 weeks and afterwards followed for 6 months. The control group will follow the usual control program for PS patients that only involves outpatient visits approximately every 3rd month. No specific PS rehabilitation program exists. The intervention group will receive TR in the form of video consultations- and chat sessions with a real physiotherapist and workout sessions with a virtual physiotherapist agent. They will also train with virtual reality glasses or tablets that show the actual exercises in the training program.
Patients will be tested with pulmonary function, physical, anxiety and quality of life parameters, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program.
详细描述
Background:
Pulmonary Sarcoidosis (PS) is defined as a multisystem granulomatous disorder of unknown cause affecting different vital organs, especially the lungs . The pathogenesis is complex and a single immunologic reaction and modulation of one cytokine is unlikely to resolve all aspects of the disease.
PS affects people throughout the world. The prevalence in Denmark is 6.4 cases per 100,000, consistent with the range of 5 to 40 per 100,000 reported from other northern European countries.
PS manifest in reduction of pulmonary function resulting in cough, dyspnea and fatigue and can be complicated by fibrosis and pulmonary hypertension. The overall symptoms lead to poor physical conditioning contributing to a vicious cycle of more physical inactivity
Treatment of sarcoidosis is usually limited to patient symptoms. In case of progressive pulmonary involvement or involvement of other vital organs, corticosteroids are indicated to prevent or stabilize organ damage. However, progressive fibrosis sometimes can lead to respiratory failure and ultimately, pulmonary transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomisation will allocate patients to either the intervention or control group. This will be performed electronically by using a randomization plan generator ("Randomization Plans: Never the Same Thing Twice!" n.d.) that has already given a randomization plan and code to generate the same plan obtained. To reproduce this study randomization plan, enter at http://www.jerrydallal.com/random/permute.htm :
24 subjects randomized into 2 blocks (intervention, control) Seed number 10180. Block randomization will be used to ensure that the numbers of participants assigned to each group is equally distributed during the different seasons.
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
- •Diagnosis of PS
- •Signed informed consent
- •Adults ≥ 18 years
- •DLCO ≥ 30% predicted and FVC ≥ 50% predicted
- •6 minute walking test distance ≥ 150 m
排除标准
- •Participation in an official rehabilitation program < 3 months before start of the study Musculoskeletal disorders
- •Severe cardiac diseases (ejection fraction < 30%, daily angina, or otherwise specified by treating cardiologist)
- •Unable to understand informed consent
- •Other conditions that hamper the use of tele-rehabilitation
- •Non-Danish speaking.
- •Unwillingness to implement the protocol
研究组 & 干预措施
Control
Patients allocated to the control group will follow the same procedure except for not using tele-rehabilitation.
Intervention
The intervention is the use of a tele-rehabilitation program during 12 weeks. The patient's training time will be registered automatically. The control group will receive standard treatment only.
干预措施: Telerehabilitation (Behavioral)
结局指标
主要结局
6MWT -12 weeks
时间窗: 12 weeks afte baseline
Change in the distance walked at a 6MWT measured at week 12.
次要结局
- Change in muscle strength measured with the MVC(12 weeks, 6 and 9 months after baseline)
- Change in total score in health-related quality of life measured by Sct. Georges Respiratory Questionnaire (Jones, Quirk, and Baveystock 1991) (SGRQ)(12 weeks, 6 and 9 months after baseline)
- 6MWT 6 and 9 month(6 and 9 months after baseline.)
- Change in fatigue measured by 10-item Fatigue Assessment Scale (FAS)(12 weeks, 6 and 9 months after baseline)
- Change in total score of anxiety measured by The General Anxiety Disorder Score (GAD-7 )(12 weeks, 6 and 9 months after baseline)
- Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ(12 weeks, 6 and 9 months after baseline)
- Change in total score in health-related quality of life measured by The King's Brief Interstitial Lung disease health status questionnaire (KBILD)(12 weeks, 6 and 9 months after baseline)
- Change in the number of steps walked measured by a pedometer.(12 weeks, 6 and 9 months after baseline)
- Cost of the tele-rehabilitation program(12 weeks after baseline)
研究者
Jose Cerdan
PhD student
Aarhus University Hospital