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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01384123
Other study ID # 0019-11-MMC
Secondary ID
Status Recruiting
Phase N/A
First received June 27, 2011
Last updated April 8, 2015
Start date August 2011
Est. completion date July 2016

Study information

Verified date October 2013
Source Meir Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 95 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel Meir medical center Kfar saba

Sponsors (1)

Lead Sponsor Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improvment in 6 minute walking distance and VO2/KG max following pulmonary rehabilitation. 16 weeks No
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