Sarcoidosis, PulmonaryTeleSarcoNCT03914027
Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis Pulmonary Sarcoidosis
A study testing Telerehabilitation in people with Sarcoidosis, Pulmonary and Telerehabilitation, run by Aarhus University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary, Telerehabilitation
- What is being tested?
- Telerehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 12 Dec 2018to 1 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of PS
- Signed informed consent
- Adults ≥ 18 years
- DLCO ≥ 30% predicted and FVC ≥ 50% predicted
- 6 minute walking test distance ≥ 150 m
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Pulmonary Disease Research Center
Aarhus, Aarhus, 8000
Jose Cerdan, 30648283, joscer@rm.dk
About this study
Official title: Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
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.
Read more
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.
Read the 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
- Being tested
- Telerehabilitation
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelerehabilitationBehavioural
Also called remote rehabilitation
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients allocated to the control group will follow the same procedure except for not using tele-rehabilitation. |
| Intervention | Experimental | 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. Receives: Behavioral: Telerehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
6MWT -12 weeks
Change in the distance walked at a 6MWT measured at week 12.
Measured: 12 weeks afte baseline
Secondary outcomes (9)
6MWT 6 and 9 month
Change in the distance walked at a 6MWT 6 and 9 months after baseline.
Measured: 6 and 9 months after baseline.
Change in muscle strength measured with the MVC
Change in muscle strength measured with the MVC of the dominant arm
Measured: 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)
SGRQ is a disease specific, self-administered questionnaire with 50 items comprising two domains with 3 components as symptoms, activity and impacts. Each is scored from 0-100, with higher scores corresponding to worse health related quality of life.
Measured: 12 weeks, 6 and 9 months after baseline
Change in fatigue measured by 10-item Fatigue Assessment Scale (FAS)
Change in fatigue measured by FAS at 12 weeks, 6 and 9 months after baseline. The 10-item Fatigue Assessment Scale (FAS)(Vries et al. 2004) (Michielsen et al. 2006) is a 10-item general fatigue questionnaire to assess fatigue. Five questions reflect physical fatigue and 5 questions (questions 3 and 6-9) mental fatigue. An answer to every question has to be given, even if the person does not have any complaints at the moment. Scores on question 4 and 10 should be recoded (1=5, 2=4, 3=3, 4=2, 5=1). Subsequently, the total FAS score can be calculated by summing the scores on all questions (recoded scores for questions 4 and 10). The total score ranges from 10 to 50. A total FAS score < 22 indicates no fatigue, a score ≥ 22 indicates fatigue. All online versions of the FAS calculate the FAS scores automatically: a total score as well as mental and physical score will be provided.
Measured: 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)
Change in total score in health-related quality of life measured by KBILD at 12 weeks, 6 and 9 months after baseline
The King's Brief Interstitial Lung disease health status questionnaire (Taylor et al. 2015) is a disease specific, validated, self-completed health status questionnaire that is comprised of 15 items. It has three domains: psychological, breathlessness, activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 = best.
Measured: 12 weeks, 6 and 9 months after baseline
Change in total score of anxiety measured by The General Anxiety Disorder Score (GAD-7 )
Change in total score of anxiety measured by GAD-7 at 12 weeks, 6 and 9 months after baseline The General Anxiety Disorder Score (Jones, Quirk, and Baveystock 1991; Löwe et al. 2008) measures the presence and severity of general anxiety disorder. It is a 7 self-rated items, each item scores 0-3 (not at all, several days, more than half the days, nearly every day); total score range 0-21.
Measured: 12 weeks, 6 and 9 months after baseline
Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ
Change in component scores (symptoms, activity \& impact) in health-related quality of life measured by SGRQ at 12 weeks, 6 and 9 months after baseline.
The King's Brief Interstitial Lung disease health status questionnaire (Taylor et al. 2015) is a disease specific, validated, self-completed health status questionnaire that is comprised of 15 items. It has three domains: psychological, breathlessness, activities and chest symptoms. The KBILD domain and total score ranges are 0-100; 100 = best.
Measured: 12 weeks, 6 and 9 months after baseline
Change in the number of steps walked measured by a pedometer.
Change in the number of steps walked measured by a pedometer.
Measured: 12 weeks, 6 and 9 months after baseline
Cost of the tele-rehabilitation program
Cost of the tele-rehabilitation program
Measured: 12 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start12 Dec 2018
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Eurostars, University of Aarhus
- Responsible party
- Principal investigator, Jose Cerdan, Aarhus University Hospital
- Investigators
- Elisabeth Bendstrup, PhD, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914027
- Sponsor's protocol ID
- TeleSarco
- Acronym
- TeleSarco
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33511633
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility & Effect of a Tele-rehabilitation Program in Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT03914027
- Acronym / sponsor ID
- TeleSarco / TeleSarco
- Conditions
- Sarcoidosis, Pulmonary, Telerehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- Eurostars, University of Aarhus
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients allocated to the control group will follow the same procedure except for not using tele-rehabilitation. |
| Intervention | Experimental | Behavioral: TelerehabilitationThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of PS
- Signed informed consent
- Adults ≥ 18 years
- DLCO ≥ 30% predicted and FVC ≥ 50% predicted
- 6 minute walking test distance ≥ 150 m
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TelerehabilitationAlso: remote rehabilitationEach 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. | Behavioural | Intervention |
Primary outcome
6MWT -12 weeks
Time frame: 12 weeks afte baseline
Change in the distance walked at a 6MWT measured at week 12.
9 secondary outcomes
6MWT 6 and 9 month
Time frame: 6 and 9 months after baseline.
Change in muscle strength measured with the MVC
Time frame: 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)
Time frame: 12 weeks, 6 and 9 months after baseline
Change in fatigue measured by 10-item Fatigue Assessment Scale (FAS)
Time frame: 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)
Time frame: 12 weeks, 6 and 9 months after baseline
Change in total score of anxiety measured by The General Anxiety Disorder Score (GAD-7 )
Time frame: 12 weeks, 6 and 9 months after baseline
Change in component scores (symptoms, activity & impact) in health-related quality of life measured by SGRQ
Time frame: 12 weeks, 6 and 9 months after baseline
Change in the number of steps walked measured by a pedometer.
Time frame: 12 weeks, 6 and 9 months after baseline
Cost of the tele-rehabilitation program
Time frame: 12 weeks after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Derived from this study: PubMed 33511633Cox 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisabeth Bendstrup, PhD, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telerehabilitation in people with Sarcoidosis, Pulmonary and Telerehabilitation, run by Aarhus University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose Cerdan, PhD stud (+4530648283, joscer@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6MWT -12 weeks (time frame: 12 weeks afte baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914027, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.