Clinical trial NCT03914027: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis Pulmonary Sarcoidosis
Official title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sarcoidosis, Pulmonary
Telerehabilitation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: Eurostars
name: University of Aarhus
First posted: 2019-04-12
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled trial. 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.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Physical training shows promising evidence of a positive effect on PF, can improve psychological health and physical functioning and also decrease fatigue, increase muscle strength and increase exercise capacity. Until today there is no defined training program with regard to exercise frequency, duration or intensities in PS contrary to chronic obstructive pulmonary diseases (COPD) or idiopathic pulmonary fibrosis (IPF).

PS is a relatively rare disease and that sarcoid 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. New technologies in healthcare are being introduced to treat patients from a distance in these years. 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. TR has previously been shown to be feasible in patients with lymphedema, COPD and orthopedic diseases for lower back, knee and shoulder.

TR with COPD patients at home is feasible and well accepted by the patients, although technology has been perceived as difficult. TR seems to improve the functional level as assessed by walking capacity, dyspnea, quality of life and daily physical activity . The interaction between the COPD patients at home and the healthcare professionals at the clinic through TR has evolved as a dialogue channel forming a basis for mutual learning processes and new relationships. 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.

There have so far been no studies on the feasibility effect of TR in PS.

Hypothesis Tele-rehabilitation in patients with PS is feasible and improves exercise capacity, quality of life and activities of daily living.

Aim To assess the feasibility and effect of tele-rehabilitation with a tele-rehabilitation platform (NITRP) compared to standard treatment with respect to exercise capacity, quality of life and activities of daily living in patients with PS.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PS
* Signed informed consent
* Adults ≥ 18 years
* DLCO ≥ 30% predicted and FVC ≥ 50% predicted
* 6 minute walking test distance ≥ 150 m

Exclusion Criteria:

* 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

Primary outcomes:
measure: 6MWT -12 weeks
timeFrame: 12 weeks afte baseline
Secondary outcomes:
measure: 6MWT 6 and 9 month
timeFrame: 6 and 9 months after baseline.
measure: Change in muscle strength measured with the MVC
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in total score in health-related quality of life measured by Sct. Georges Respiratory Questionnaire (Jones, Quirk, and Baveystock 1991) (SGRQ)
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in fatigue measured by 10-item Fatigue Assessment Scale (FAS)
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in total score in health-related quality of life measured by The King's Brief Interstitial Lung disease health status questionnaire (KBILD)
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in total score of anxiety measured by The General Anxiety Disorder Score (GAD-7 )
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Change in the number of steps walked measured by a pedometer.
timeFrame: 12 weeks, 6 and 9 months after baseline
measure: Cost of the tele-rehabilitation program
timeFrame: 12 weeks after baseline
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Pulmonary Disease Research Center
state: Aarhus
Study officials:
affiliation: Aarhus University Hospital
name: Elisabeth Bendstrup, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox NS, Dal Corso S, Hansen H, McDonald CF, Hill CJ, Zanaboni P, Alison JA, O'Halloran P, Macdonald H, Holland AE. Telerehabilitation for chronic respiratory disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013040. doi: 10.1002/14651858.CD013040.pub2.