Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis Pulmonary Sarcoidosis

NCT ID: NCT03914027

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-12
• Study Completion Date: 2025-10-01

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.

Conditions

Sarcoidosis, Pulmonary; Telerehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Patients allocated to the control group will follow the same procedure except for not using tele-rehabilitation.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Telerehabilitation

Intervention Type: BEHAVIORAL

Each patient will have the opportunity to have minimum one VC per week the first month, one Video Consultation each second week the second month one VC a month the rest of the trial. Here the physiotherapist, via history will extract the information needed to calibrate the daily TR program according to the patient's physical status and needs.

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.

Interventions

Telerehabilitation

Each patient will have the opportunity to have minimum one VC per week the first month, one Video Consultation each second week the second month one VC a month the rest of the trial. Here the physiotherapist, via history will extract the information needed to calibrate the daily TR program according to the patient's physical status and needs.

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

remote rehabilitation

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurostars

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jose Cerdan

PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth Bendstrup, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

Pulmonary Disease Research Center

Aarhus, Aarhus, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Jose Cerdan, PhD stud

Role: CONTACT

joscer@rm.dk

+4530648283

Elisabeth Bendstrup, PhD, MD

Role: CONTACT

karbends@rm.dk

+45 7846 2201

Facility Contacts

Jose Cerdan

Role: primary

joscer@rm.dk

30648283

References

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.

Reference Type: DERIVED

PMID: 33511633 (View on PubMed)

Other Identifiers

TeleSarco

Identifier Type: -

Identifier Source: org_study_id