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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000093785
Enrollment
6
Registered
2022-01-24
Start date
2022-02-14
Completion date
2023-01-01
Last updated
2025-01-06

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

Conditions

None listed

Brief summary

Inclusion Body Myositis (IBM) is increasingly being associated with respiratory muscle weakness. The purpose of this study is to implement an at-home 12 week long inspiratory muscle training (IMT) program and compare measures of respiratory muscle strength, functionality, sleep quality and quality of life before and after the intervention in 15 IBM patients. IMT protocols have been effective in many medical conditions including other neurological disorders so we hypothesise that it will improve IBM patients' inspiratory muscle strength while secondarily improving functionality, sleep quality and quality of life.

Interventions

Intervention: An intervention protocol has been chosen following a review of the literature reviewing IMT in people with neuromuscular disorders. The training protocol is as follows: Participants will complete an inspiratory training session twice a day at home with a Philips Respironics Threshold Inspiratory Muscle Training (IMT) device, 5 days each week, for approximately 10 minutes each session. This program would take a total of twelve weeks and involve a starting resistance of 30% of partic

Intervention: An intervention protocol has been chosen following a review of the literature reviewing IMT in people with neuromuscular disorders. The training protocol is as follows: Participants will complete an inspiratory training session twice a day at home with a Philips Respironics Threshold Inspiratory Muscle Training (IMT) device, 5 days each week, for approximately 10 minutes each session. This program would take a total of twelve weeks and involve a starting resistance of 30% of participants’ maximal inspiratory pressure (MIP) as measured at their first visit to the IIID Clinic. Resistance would then increase every second week by 10% of their MIP, such that the third and fourth week involves a resistance of 40% of their original MIP, the fifth and sixth weeks at 50% of original MIP and the final six weeks of training involving a resistance of 60% of their original MIP. In each session, participants would aim to complete 4 sets of 10 inhalation repetitions with a 1-minute break consisting of non-resisted breathing between each set. Each participant will keep a journal to track compliance or adverse effects and will have a weekly telephone or zoom check in with someone from the research team to discuss their training compliance and any concerns they may have. Education of the device will be conducted during initial testing by their regular care team including specific device education with their physiotherapist who has over 30 years of experience.

Sponsors

IIID Murdoch
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026