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Inspiratory Muscle Training in Sarcoidosis

Effects of Inspiratory Muscle Training in Patients With Sarcoidosis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02270333
Enrollment
30
Registered
2014-10-21
Start date
2012-04-30
Completion date
2014-04-30
Last updated
2014-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis

Keywords

sarcoidosis, inspiratory muscle strength, exercise capacity, quality of life

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.

Interventions

DEVICEInspiratory muscle training

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.

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.

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum inspiratory and expiratory muscle strength (MIP, MEP)6 weeksMouth pressure device

Secondary

MeasureTime frameDescription
Maximal Exercise Capacity6 weeksModified incremental shuttle walk test (ISWT)
Fatigue6 weeksFatigue Severity Scale (FSS)
Pulmonary function and diffusing capacity6 weeksSpirometry
Exercise Capacity6 weeksSix-minute walk test (6MWT)
Dyspnea6 weeksModified Borg and Modified Medical Research Council (MMRC) dyspnea scales
Depression6 weeksMontgomery Asberg Depression Rating Scale (MADRS))
Quality of life6 weeksSaint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)
Peripheral muscle strength6 weeksHand-held dynamometer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 3, 2026