Does Inspiratory Muscle Training Improve Lung Function and Quality of Life in people with Inclusion Body Myositis?

Not Applicable

• Conditions: Inclusion body myositis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Musculoskeletal - Other muscular and skeletal disorders

• Registration Number: ACTRN12622000093785
• Lead Sponsor: IIID Murdoch

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-24
• Last Update Posted: 31 January 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Patients with a confirmed diagnosis of definite or probable Inclusion Body Myositic (IBM) according to the European Neuromuscular Centre 2011 diagnostic criteria who are currently being clinically managed at the Myositis Clinic, IIID, Murdoch University.
-Patients with a vital capacity equal to or less than 80% of predicted values
-Be able to complete a two minute walk test (2MWT)
-Must be able to attend an appointment at the Myositis Clinic, IIID within the first four months of 2022 and a follow-up appointment eight weeks later.
-Be able to provide informed consent

Exclusion Criteria

-Diagnosed co-morbid respiratory disease e.g. chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis but not including sleep-disordered breathing
-Current smokers
-Current or recent respiratory infections (within 4 weeks of the first appointment) or respiratory infection during the duration of the intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength via maximal inspiratory pressure (MIP) measured using the MicroRPM (Carefusion Corporation, San Diego, CA) after education as to how to complete the testing following the European Respiratory Society guidelines.[12 weeks post initial test];Inspiratory muscle strength via sniff nasal inspiratory pressure (SNIP) measured using the MicroRPM (Carefusion Corporation, San Diego, CA) after education as to how to complete the testing following the European Respiratory Society guidelines.[12 weeks post initial test]

Secondary Outcome Measures

Name	Time	Method
Vital capacity (VC) via the Vitalograph In2itive hand-held Spirometer[12 weeks post initial test];2-minute walk test (2MWT) distance[12 weeks post initial test]; Quality of life via inclusion body myositis functional rating scale[12 weeks post initial test]; Quality of sleep via the Pittsburgh Sleep Quality Index[12 weeks post initial test];2-minute walk test (2MWT) breathlessness score (via a Borg score) [12 weeks post initial test];Quality of life via the SF-36 questionnaires [12 weeks post initial test]; Quality of sleep via the Epworth Sleepiness Scale for daytime tiredness[12 weeks post initial test]