Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study

Status Recruiting

Clinical Trial Summary

Sarcoidosis is a heterogeneous multisystem disorder of unknown etiology which often presents with bilateral hilar lymphadenopathy, pulmonary infiltration and ocular and skin lesions. In addition to possible changes in forced vital capacity (FVC) and carbon monoxide transfer factor (TLCO), a higher prevalence of clinical depression, reduced health status and exercise intolerance have been observed in patients with sarcoidosis.

Reduced health status has been related to decreased pulmonary function, depressive symptoms, and to respiratory muscle weakness. Exercise capacity is believed to be limited by dyspnea, an insufficient heart rate response, decreased arterial oxygen tension during exercise, excessive and inefficient ventilation and by respiratory muscle weakness.

In the past, exercise capacity was shown to be limited by skeletal muscle weakness in patients with chronic pulmonary or cardiac disease. 67% of the sarcoidosis patients studied by Miller et al terminated their peak exercise test due to "leg complaints". Skeletal muscle weakness is therefore still assumed to be present in patients with sarcoidosis.

Treatment with oral corticosteroids, clinical symptoms of depression, myositis, self-reported complaints of fatigue and high circulating levels of tumour necrosis factor-α (TNF-α) are all present in patients with sarcoidosis and can all affect skeletal muscle force and exercise capacity. Additionally, low levels of circulating insulin-like growth factor I (IGF-I), which can be induced by high levels of TNF-α, and high circulating levels of interleukin (IL)-6 and IL-8 (CXCL8) have been associated with skeletal muscle weakness. These interleukins are part of the current concept of the immunopathogenesis of sarcoidosis16 and may be raised in patients with stable sarcoidosis.

Recent studies have shown that pulmonary rehabilitation program can lead to improve in the health status and anxiety among patients with chronic obstructive lung disease .However, no study has evaluated the role of pulmonary rehabilitation among patients with sarcoidosis.

Clinical Trial Description

n/a

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01384123
Study type	Observational
Source	Meir Medical Center
Contact
Status	Recruiting
Phase	N/A
Start date	August 2011
Completion date	July 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04064242` - Study of Efficacy, Safety and Tolerability of CMK389 in Patients With Chronic Pulmonary Sarcoidosis	Phase 2
Terminated	`NCT00262132` - Mycophenolate for Pulmonary Sarcoidosis	Phase 3
Recruiting	`NCT05415137` - Efficacy and Safety of Intravenous Efzofitimod in Patients With Pulmonary Sarcoidosis	Phase 3
Recruiting	`NCT00001532` - Role of Genetic Factors in the Development of Lung Disease
Completed	`NCT04318392` - Breath Analysis in Patients With Suspected Sarcoidosis: The VOCs-IS Study
Active, not recruiting	`NCT03755245` - Biodistribution, Dosimetry and Performance of [68Ga]Ga-DOTA-Siglec-9 in Healthy and Patients With Rheumatoid Arthritis, Vasculitis or Pulmonary Sarcoidosis	N/A
Completed	`NCT01587001` - The Effect of N-Acetyl-L-Cysteine, on Inflammatory and Oxidative Stress Markers in Pulmonary Sarcoidosis	N/A
Recruiting	`NCT05890729` - A Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis	Phase 1/Phase 2
Recruiting	`NCT02824419` - Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis	Phase 2/Phase 3
Recruiting	`NCT06205121` - Efficacy and Safety Study of OATD-01 in Patients With Active Pulmonary Sarcoidosis	Phase 2
Completed	`NCT02200146` - Hydroxychloroquine as Steroid-Sparing Agent in Pulmonary Sarcoidosis (HySSAS).	Phase 3
Terminated	`NCT01732211` - A Phase 2, Safety, Tolerability, and Efficacy Study of PD 0360324 in Chronic Pulmonary Sarcoidosis	Phase 2
Enrolling by invitation	`NCT06169397` - An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis	Phase 2
Active, not recruiting	`NCT05368883` - Comparison of the Effects of One-Legged and Two-Legged Exercise Training on Exercise Capacity and Fatigue in Patients With Sarcoidosis	N/A
Not yet recruiting	`NCT05247554` - Randomized Controlled Trial of Hydroxychloroquine Combined With Low-dose Corticosteroid in Pulmonary Sarcoidosis	Phase 3
Completed	`NCT03599414` - CASPA: CArdiac Sarcoidosis in PApworth
Recruiting	`NCT02188017` - Acthar Gel for Chronic Pulmonary Sarcoidosis (ACPS)	Phase 4
Recruiting	`NCT06113991` - Study Comparing Chronic Beryllium Disease to Pulmonary Sarcoidosis
Completed	`NCT01169038` - Investigation of the Efficacy of Antibiotics on Pulmonary Sarcoidosis	Phase 1
Completed	`NCT00701207` - Study of Nicotine Patches in Patients With Sarcoidosis	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.