Inspiratory Muscle Training in Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Effects of Inspiratory Muscle Training in Patients With Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02270333
• Other study ID #: GaziU
• Status: Completed
• Phase: N/A
• First received: October 8, 2014
• Last updated: October 18, 2014
• Start date: April 2012
• Est. completion date: April 2014

Study information

• Verified date: October 2014
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Respiratory Aspiration
• Sarcoidosis

Intervention

Device:
• Inspiratory 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.
• Sham inspiratory muscle training
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

References & Publications (4)

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. — View Citation

Kabitz HJ, Lang F, Walterspacher S, Sorichter S, Müller-Quernheim J, Windisch W. Impact of impaired inspiratory muscle strength on dyspnea and walking capacity in sarcoidosis. Chest. 2006 Nov;130(5):1496-502. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum inspiratory and expiratory muscle strength (MIP, MEP)	Mouth pressure device	6 weeks	Yes
Secondary	Exercise Capacity	Six-minute walk test (6MWT)	6 weeks	Yes
Secondary	Maximal Exercise Capacity	Modified incremental shuttle walk test (ISWT)	6 weeks	Yes
Secondary	Fatigue	Fatigue Severity Scale (FSS)	6 weeks	Yes
Secondary	Pulmonary function and diffusing capacity	Spirometry	6 weeks	Yes
Secondary	Peripheral muscle strength	Hand-held dynamometer	6 weeks	Yes
Secondary	Dyspnea	Modified Borg and Modified Medical Research Council (MMRC) dyspnea scales	6 weeks	Yes
Secondary	Depression	Montgomery Asberg Depression Rating Scale (MADRS))	6 weeks	Yes
Secondary	Quality of life	Saint George's Respiratory Questionnaire (SGRQ) (Turkish versions of all scales)	6 weeks	Yes