Clinical trial NCT02270333: Inspiratory Muscle Training in Sarcoidosis
Official title: Effects of Inspiratory Muscle Training in Patients With Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis
Keywords: sarcoidosis
inspiratory muscle strength
exercise capacity
quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2014-10-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Respiratory muscle weakness results with decreased exercise capacity, worse fatigue, dyspnea and quality of life in patients with sarcoidosis. However, no study investigated the effects of inspiratory muscle training (IMT), therefore effects of IMT on outcomes in patients with sarcoidosis were investigated.

Detailed description: Patients were diagnosed with sarcoidosis according to the criteria of the latest American Thoracic Society (ATS)/European Respiratory Society (ERS)/World Association of Sarcoidosis and Other Granulomatous (WASOG) Disorders statement on sarcoidosis. Primary outcome measurement was respiratory muscle strength, secondary outcomes were, exercise capacity quality of life, fatigue and depression.

Eligibility criteria: Inclusion Criteria:

* Clinically stable
* Under standard medication
* Stage I and IV
* No change in medications over three months

Exclusion Criteria:

* Cognitive disorders
* Current corticosteroid use
* Having co-morbidity to prevent performing IMT
* Acute infection
* Orthopedic and neurological problems

Primary outcomes:
measure: Maximum inspiratory and expiratory muscle strength (MIP, MEP)
timeFrame: 6 weeks
Secondary outcomes:
measure: Exercise Capacity
timeFrame: 6 weeks
measure: Maximal Exercise Capacity
timeFrame: 6 weeks
measure: Fatigue
timeFrame: 6 weeks
measure: Pulmonary function and diffusing capacity
timeFrame: 6 weeks
measure: Peripheral muscle strength
timeFrame: 6 weeks
measure: Dyspnea
timeFrame: 6 weeks
measure: Depression
timeFrame: 6 weeks
measure: Quality of life
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Gazi University
name: Müşerrefe Nur Karadallı, MSc.
role: STUDY_CHAIR
affiliation: Gazi University
name: Burcu Camcıoğlu, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Meral Boşnak Güçlü, PhD
role: STUDY_DIRECTOR
affiliation: Gazi University
name: Nurdan Köktürk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gazi University
name: Haluk Türktaş, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Spruit MA, Thomeer MJ, Gosselink R, Troosters T, Kasran A, Debrock AJ, Demedts MG, Decramer M. Skeletal muscle weakness in patients with sarcoidosis and its relationship with exercise intolerance and reduced health status. Thorax. 2005 Jan;60(1):32-8. doi: 10.1136/thx.2004.022244.
citation: Kabitz HJ, Lang F, Walterspacher S, Sorichter S, Muller-Quernheim J, Windisch W. Impact of impaired inspiratory muscle strength on dyspnea and walking capacity in sarcoidosis. Chest. 2006 Nov;130(5):1496-502. doi: 10.1378/chest.130.5.1496.
citation: Baydur A, Alsalek M, Louie SG, Sharma OP. Respiratory muscle strength, lung function, and dyspnea in patients with sarcoidosis. Chest. 2001 Jul;120(1):102-8. doi: 10.1378/chest.120.1.102.
citation: Wirnsberger RM, Drent M, Hekelaar N, Breteler MH, Drent S, Wouters EF, Dekhuijzen PN. Relationship between respiratory muscle function and quality of life in sarcoidosis. Eur Respir J. 1997 Jul;10(7):1450-5. doi: 10.1183/09031936.97.10071450.
citation: Karadalli MN, Bosnak-Guclu M, Camcioglu B, Kokturk N, Turktas H. Effects of Inspiratory Muscle Training in Subjects With Sarcoidosis: A Randomized Controlled Clinical Trial. Respir Care. 2016 Apr;61(4):483-94. doi: 10.4187/respcare.04312. Epub 2015 Dec 29.