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Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis Pulmonary Sarcoidosis
Study Purpose
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.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03914027 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
N/A |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Aarhus University Hospital |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Elisabeth Bendstrup, PhD, MD |
Principal Investigator Affiliation | Aarhus University Hospital |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Denmark |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Sarcoidosis, Pulmonary, Telerehabilitation |
Contact a Trial Team
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