Inspiratory Muscle Training in Sarcoidosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Inspiratory Muscle Training in Patients With Sarcoidosis

Conditions
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Sarcoidosis

Intervention / Treatment
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* Device: Inspiratory muscle training
* Device: Sham inspiratory muscle training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment group<br>Intervention: Treatment group received inspiratory muscle training (IMT) using POWERbreathe Classic threshold loading device . | Device: Inspiratory muscle training<br>* Treatment group received inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP). The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload. The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.<br>|
| Sham Comparator: Control group<br>Sham: Control group received sham inspiratory muscle training using POWERbreathe Classic threshold loading device . | Device: Sham inspiratory muscle training<br>* Control group received sham inspiratory muscle training (IMT) at fixed workload, 5% of MIP using threshold loading device (POWERbreathe Classic device IMT Technologies Ltd. Birmingham, England). The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum inspiratory and expiratory muscle strength (MIP, MEP) | Mouth pressure device | 6 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcoidosis, inspiratory muscle strength, exercise capacity, quality of life