Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000093785p
Ethics application status
Submitted, not yet approved
Date submitted
16/12/2021
Date registered
24/01/2022
Date last updated
24/01/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Does Inspiratory Muscle Training Improve Lung Function and Quality of Life in people with Inclusion Body Myositis?
Scientific title
Does Inspiratory Muscle Training Improve Lung Function and Quality of Life in people with Inclusion Body Myositis?
Secondary ID [1] 305986 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inclusion body myositis 324616 0
Condition category
Condition code
Inflammatory and Immune System 322078 322078 0 0
Other inflammatory or immune system disorders
Musculoskeletal 322299 322299 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 322401 0
Treatment: Devices
Intervention code [2] 322567 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 329845 0
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.
Timepoint [1] 329845 0
12 weeks post initial test
Primary outcome [2] 330064 0
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.
Timepoint [2] 330064 0
12 weeks post initial test
Secondary outcome [1] 404039 0
Vital capacity (VC) via the Vitalograph In2itive hand-held Spirometer
Timepoint [1] 404039 0
12 weeks post initial test
Secondary outcome [2] 404040 0
2-minute walk test (2MWT) distance
Timepoint [2] 404040 0
12 weeks post initial test
Secondary outcome [3] 404041 0
Quality of life via inclusion body myositis functional rating scale
Timepoint [3] 404041 0
12 weeks post initial test
Secondary outcome [4] 404042 0
Quality of sleep via the Pittsburgh Sleep Quality Index
Timepoint [4] 404042 0
12 weeks post initial test
Secondary outcome [5] 404784 0
2-minute walk test (2MWT) breathlessness score (via a Borg score)
Timepoint [5] 404784 0
12 weeks post initial test
Secondary outcome [6] 404785 0
Quality of life via the SF-36 questionnaires
Timepoint [6] 404785 0
12 weeks post initial test
Secondary outcome [7] 404786 0
Quality of sleep via the Epworth Sleepiness Scale for daytime tiredness
Timepoint [7] 404786 0
12 weeks post initial test

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A p value of below .05 was selected to determine significance in this study with a power of 80%. This requires a sample size of 11 using Fry et al.’s data (1) or 30 when considering Jones et al.’s (2) results, both in neuromuscular patients. Given the rare nature of IBM, limitation of device availability and the pilot nature of this study, a sample size of 15 was chosen.
All patients in the intervention group will be included in the data analysis. The mean’s of the continuous data (MIP, SNIP, VC, 2MWT distance, 2MWT breathlessness, QoL and sleep questionnaires) will be analysed via a paired T-test (if data is normally distributed) or Wilcoxon signed-rank test (if data is not normally distributed) for the initial and final testing values. If relevant, demographic data and treatment response can be analysed by Chi-squared tests or Fishers exact test. No adjustments to the values are anticipated to be needed,

1. Fry DK, Pfalzer LA, Chokshi AR, Wagner MT, Jackson ES. Randomized Control Trial of Effects of a 10-Week Inspiratory Muscle Training Program on Measures of Pulmonary Function in Persons with Multiple Sclerosis. Journal of neurologic physical therapy. 2007;31(4):162-172. doi:10.1097/NPT.0b013e31815ce136
2. Jones HN, Kuchibhatla M, Crisp KD, et al. Respiratory muscle training in late-onset Pompe disease: Results of a sham-controlled clinical trial. Neuromuscul Disord. 2020;30(11):904-914. doi:10.1016/j.nmd.2020.09.023

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/02/2022
Actual
Date of last participant enrolment
Anticipated
31/03/2022
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 310327 0
Other
Name [1] 310327 0
IIID Murdoch
Country [1] 310327 0
Australia
Primary sponsor type
Other
Name
IIID Murdoch
Address
Health Research Centre, Discovery Wy, Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 311453 0
None
Name [1] 311453 0
N/A
Address [1] 311453 0
N/A
Country [1] 311453 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309988 0
Murdoch University Human Research Ethics Committee (HREC)
Ethics committee address [1] 309988 0
Ethics committee country [1] 309988 0
Australia
Date submitted for ethics approval [1] 309988 0
08/12/2021
Approval date [1] 309988 0
Ethics approval number [1] 309988 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116090 0
Prof Merrilee Needham
Address 116090 0
Institute for Immunology and Infectious Diseases
Building 390 Discovery Way
Murdoch, WA 6150
Australia
Country 116090 0
Australia
Phone 116090 0
+61 8 9360 1334
Fax 116090 0
Email 116090 0
[email protected]
Contact person for public queries
Name 116091 0
Ian Cooper
Address 116091 0
Institute for Immunology and Infectious Diseases
Building 390 Discovery Way
Murdoch, WA 6150
Australia
Country 116091 0
Australia
Phone 116091 0
+61 8 9360 1349
Fax 116091 0
Email 116091 0
[email protected]
Contact person for scientific queries
Name 116092 0
Ethan Williams
Address 116092 0
Institute for Immunology and Infectious Diseases
Building 390 Discovery Way
Murdoch, WA 6150
Australia
Country 116092 0
Australia
Phone 116092 0
+61 434 032 522
Fax 116092 0
Email 116092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14370Informed consent form    383258-(Uploaded-16-12-2021-15-47-29)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.