Feasibility & Effect of a Tele-rehabilitation Program in Idiopathic Pulmonary Fibrosis (IPF)
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in the distance walked at a 6MWT measured at week 12
研究概览
简要总结
Introduction Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of unknown cause with a median survival of 3-5 years. As the disease progresses, worsening of lung function and gas exchange impairment cause hypoxemia during physical activity leading to a downward spiral; dyspnea and fatigue lead to a reduction in daily physical activities, exercise tolerance, muscle strength and quality of life. Problems reported by IPF patients are social isolation, increased level of dependency and immobility.
There is no curative treatment for IPF, but pulmonary rehabilitation (PR) is recommended by expert opinion for the majority of IPF patients in order to improve quality of life and exercise tolerance. There are, however, no official PR programs for IPF patients and they therefore either participate in PR programs patients with chronic obstructive lung diseases (COPD) or train by themselves in fitness centers without guidance. PR for COPD is mostly offered in specialized clinics with an average duration of 8 weeks. Not all patients with IPF are fit for these programs or want to participate in an extensive external program due to, among other reasons, distance to the clinic. Tele-rehabilitation may offer these patients an alternative.
New technologies in healthcare that can treat patients from a distance are implemented in these years. Tele-rehabilitation has been shown to be feasible in patients with lymphedema, COPD, orthopedic diseases (lower back, knee and shoulder). To ensure that all IPF patients are offered the possibility to participate in IPF specific rehabilitation programs, even though they live far away from expert ILD centers, tele-rehabilitation might be an alternative to participation in COPD rehabilitation programs. There have so far been no studies on the feasibility effect of tele-rehabilitation in IPF.
Aim To assess the feasibility and effect of tele-rehabilitation with a new and innovative TR platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with IPF.
Method & material The study is a prospective randomized controlled trial comparing the effects of tele-rehabilitation and standard treatment in patients with IPF. 24 patients with IPF will be randomized in two groups, and the intervention group trained by tele-rehabilitation for 12 weeks with follow-up after training at 3 and 6 months. The control group will follow the usual control program for IPF patients that only involves outpatient visits approximately every 3rd month. The intervention group will recieve tele-rehabilitation.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 parameters, 6 minute walk test, a pedometer registering steps walked in 7 days, King's brief ILD questionnaire (a disease specific quality of life questionnaire), the General Anxiety Disorder Score (GAD-7) (measures the presence and severity of general anxiety disorder) and the SGRQ-IPF, a disease specific, self-administered questionnaire for IPF, all at baseline, after 12 weeks of intervention, 3 and 6 months after cessation of the program
详细描述
Background:
Idiopathic Pulmonary Fibrosis (IPF) is a progressive fibrotic lung disease of unknown cause with a median survival of 3-5 years (Raghu et al. 2011). As the disease progresses, worsening of lung function and gas exchange impairment cause hypoxemia during physical activity leading to a downward spiral; dyspnea and fatigue lead to a reduction in daily physical activities, exercise tolerance, muscle strength and quality of life (Behr et al. 2013)(Holl and Hill, 2008). Problems reported by IPF patients are social isolation, increased level of dependency and immobility (Bajwah et al. 2012)(De Vries et al. 2001).
No curative treatment exists (Raghu et al. 2011). Pulmonary rehabilitation (PR) is recommended by expert opinion for the majority of IPF patients to improve quality of life and exercise tolerance (Raghu et al. 2011) (Behr et al. 2013). These programs are mostly offered in specialized clinics with an average duration of 8 weeks (Holl et al. 2008)(Nishiyama et al. 2008)(Jastrzebski et al. 2006)(Huppmann et al. 2012)(Verma et al. 2011)(J J Swigris et al. 2005). Not all patients with IPF are fit for these programs or want to participate in an extensive external program due to, among other reasons, distance to the clinic. Tele-rehabilitation may offer these patients an alternative.
Tele-rehabilitation seems to be a good approach to reach patients in low inhabited areas (Hill and Sppath, 2010), going from health care to self-care (Haarder 2011), empowering patient's awareness of their disease and increasing the flexibility patients need to acquire healthier behaviors. Tele-rehabilitation has previously been shown to be feasible in patients with lymphedema (Galiano-Castillo et al. 2014), COPD (Paneroni et al. 2014)(Tousignant et al. 2012)(Dinesen, Seeman, and Gustafsson, 2011)(Dinesen, Huniche, and Toft, 2013) and orthopedic diseases, lower back (Palacín-Marín, Esteban-Moreno, Olea, Herrera-Viedma, and Arroyo-Morales, 2013), knee (Cabana et al. 2010) (Tousignant, Moffet, et al. 2011) (Tousignant, Boissy, et al. 2011) and shoulder (Eriksson, Lindström, Gard, and Lysholm, 2009)(Eriksson, Lindström, and Ekenberg, 2011).
Tele-rehabilitation with COPD patients at home is feasible and well accepted by the patients, although technology has been perceived as difficult (Paneroni et al., 2014)(Tousignant et al.,2012). Tele-rehabilitation seems to improve the functional level as assessed by walking capacity, dyspnea, quality of life and daily physical activity (Paneroni et al. 2014). The interaction between the COPD patients at home and the healthcare professionals at the clinic through tele-rehabilitation has evolved as a dialogue channel forming a basis for mutual learning processes and new relationships (Dinesen, ersen, Hejlesen, & Toft, 2011). Preliminary evaluations from tele-rehabilitation initiatives in Scotland showed tele-rehabilitation to be more cost effective with patients living in remote areas than with the outreach- or centralized model (Hill and Sppath, 2010).
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, Outcomes Assessor)
盲法说明
The study is a randomized controlled trial
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, the patient must meet all of the following criteria:
- •Diagnosis of either definite or possible IPF according to the American Thoracic Society (ATS) and European Respiratory Society (ERS) criteria Signed informed consent DLCO ≥ 30% predicted and FVC ≥ 50% predicted 6 minute walking test ≥ 150 m Adults ≥ 18 years Being clinically stable Absolute decline in DLCO & FVC should be less than 10% in the past 6 months.
排除标准
- •A potential patient who meets any of the following criteria will be excluded from participation in this study if:
- •Participation in an official rehabilitation program < 4 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
Intervention group "tele-rehabilitation"
Each patient will have the opportunity to have minimum one Video Consultation (VC) per week the first month, one VC each second week the second month one VC a month the rest of the trial.
Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA. Instead of ergometer bike training, the patient will receive some easy training tools such as elastics, weights and a fitness-step that can be used in the different exercises showed by the VPA to reach the same intensity of workout. The VPA will then be animated to motivate and encourage the patient to exercises at home. A digital diary will automatically register the data obtained by the system on patient's performance.
干预措施: Virtual Autonomous Physiotherapist Agent (VAPA) (Behavioral)
Control
Patients will be followed, but they do not get any other kind of treatment comparable to the intervention group treatment.
干预措施: Virtual Autonomous Physiotherapist Agent (VAPA) (Behavioral)
结局指标
主要结局
Change in the distance walked at a 6MWT measured at week 12
时间窗: 12 weeks
Change in the distance walked at a 6MWT measured at week 12
次要结局
- Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ-IPF(at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.)
- Change in total score of anxiety measured by GAD-7(at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.)
- Change in the distance walked at a 6MWT(measured 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline)
- Change in total score in health-related quality of life measured by SGRQ-IPF(at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.)
- Change in total score in health-related quality of life measured by KBILD(at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.)
- Change in the number of steps walked measured by a pedometer.(at week 12, and 3 and 6 months after cessation of the tele-rehabilitation program compared to baseline.)
- Cost of the tele-rehabilitation program(At week 12)