Clinical trial NCT01384123: Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Sarcoidosis
Keywords: stable pulmonary sarcoidosis with no change in medication during the last 3 months/
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Fifty consecutive Pulmonary sarcoidosis patients who are treated at the outpatient interstitial lung disease clinic in MEIR Medical Center.

Pulmonary Sarcoidosis will be diagnosed according to the latest ATS/ERS/WASOG statement on sarcoidosis.1 Diagnosis of pulmonary sarcoidosis. The morphologic diagnosis of pulmonary sarcoidosis relies on three main findings: the presence of tight, well-formed granulomas and a rim of lymphocytes and fibroblasts in the outer margin of granulomas; perilymphatic interstitial distribution of granulomas (which allows transbronchial biopsies to be used as sensitive diagnostic tools); and exclusion of an alternative cause

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Stable pulmonary sarcoidosis with no change in medication during the last 3 months.

Exclusion Criteria:

* Any significant other pulmonary and\\or co-morbidity that can affect exercise tolerance.
* Chronic steroid treatment more than 5 mg/day.
* Previous lung surgery.
* Advanced heart failure (NYHA III-IV )
* Malignancy during the last 3 years

Primary outcomes:
measure: Improvment in 6 minute walking distance and VO2/KG max following pulmonary rehabilitation.
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar saba
country: Israel
facility: Meir medical center
Study officials:
References: