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Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study

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ClinicalTrials.gov Identifier: NCT01384123
Recruitment Status : Unknown
Verified October 2013 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : June 28, 2011
Last Update Posted : April 9, 2015
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Tracking Information
First Submitted Date June 27, 2011
First Posted Date June 28, 2011
Last Update Posted Date April 9, 2015
Study Start Date August 2011
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2013)
Improvment in 6 minute walking distance and VO2/KG max following pulmonary rehabilitation. [ Time Frame: 16 weeks ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rehabilitation in Pulmonary Sarcoidosis: a Prospective Study
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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

Condition Pulmonary Sarcoidosis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 27, 2011)
50
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2016
Estimated Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 95 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT01384123
Other Study ID Numbers 0019-11-MMC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Meir Medical Center
Study Sponsor Meir Medical Center
Collaborators Not Provided
Investigators Not Provided
PRS Account Meir Medical Center
Verification Date October 2013