Inspiratory Muscle Training in Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis
• Interventions: Device: Sham inspiratory muscle training; Device: Inspiratory muscle training

• Registration Number: NCT02270333
• Lead Sponsor: Gazi University

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.

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2013-09
• Study Completion: 2014-04
• Status Verified: 2014-10
• Study First Submitted: 2014-10-08
• Study First Submitted QC: 2014-10-18
• Last Update Submitted: 2014-10-18
• Study First Posted: 2014-10-21
• Last Update Posted: 2014-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Sham inspiratory muscle training	Sham: Control group received sham inspiratory muscle training using POWERbreathe Classic threshold loading device .
Treatment group	Inspiratory muscle training	Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device .

Primary Outcome Measures

Name	Time	Method
Maximum inspiratory and expiratory muscle strength (MIP, MEP)	6 weeks	Mouth pressure device

Secondary Outcome Measures

Name	Time	Method
Exercise Capacity	6 weeks	Six-minute walk test (6MWT)
Pulmonary function and diffusing capacity	6 weeks	Spirometry
Fatigue	6 weeks	Fatigue Severity Scale (FSS)
Dyspnea	6 weeks	Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales
Maximal Exercise Capacity	6 weeks	Modified incremental shuttle walk test (ISWT)
Peripheral muscle strength	6 weeks	Hand-held dynamometer
Quality of life	6 weeks	Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)
Depression	6 weeks	Montgomery Asberg Depression Rating Scale (MADRS))