Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000097741
Ethics application status
Approved
Date submitted
15/12/2021
Date registered
24/01/2022
Date last updated
10/01/2023
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Inspiratory muscle training for people with Parkinson's disease
Scientific title
Effect of inspiratory muscle training on maximal inspiratory pressure in people with Parkinson's disease
Secondary ID [1] 306049 0
Nil known
Universal Trial Number (UTN)
U1111-1272-5623
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 324692 0
Inspiratory muscle weakness 324693 0
Dyspnoea 324704 0
Exercise capacity 324706 0
Quality of life 324707 0
Difficulty performing daily living activities 324863 0
Condition category
Condition code
Neurological 322140 322140 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the intervention group will complete inspiratory muscle training at home using a threshold inspiratory muscle trainer (PowerBreathe® Medic plus, Southam, United Kingdom). Participants will participate in their inspiratory muscle training program 5 days a week, which should take approximately 10 minutes per day and keep a diary of adherence, which will continue for 8 weeks. Daily training will be 5 sets of 6 breaths against the prescribed inspiratory resistance. We will monitor patients once per week (phone call) to discuss any questions and update their training pressures if need be. After the initial 4 weeks, participants will also be asked to attend a face-to-face appointment to discuss their progress, review their technique and clarify any issues concerning the training program. The weekly check will take 10 to 15 minutes, and the face-to-face appointment will take 20 to 30 minutes, depending on participant requirements.

Training will be conducted by a physiotherapist experienced in delivering inspiratory muscle training. Therapist cannot be blinded to group allocation.

After completing 8-week inspiratory muscle training, eligible participants will be offered to participate in individual semi-structured interviews within one month of completing the intervention. All interviews are expected to last approximately 60 minutes each and will be facilitated by a trained researcher who has not been responsible for delivery of intervention. Open-ended questions will guide the interviews following to reflect the experiences of the inspiratory muscle training in people with Parkinson's disease, their experiences of breathlessness and perceptions of its impact on activities of daily living.
Intervention code [1] 322448 0
Rehabilitation
Comparator / control treatment
Usual care (control group) will involve participants ongoing management for Parkinson's disease. After baseline assessment, participants will be asked to record any exercise they complete in a diary, including individual exercise routines, for 8 weeks. This may include participating in physiotherapy exercise classes provided by the UC Health Clinics Student Led Neurological Physiotherapy Clinic or other activities within the community such as biking, running, dancing, no-contact boxing, and others.

After the initial 4 weeks, participants wil receive a phone call to check if they have been recording their exercise and discuss any questions. The call will take 5 to 10 minutes, depending on participant requirements.
Control group
Active

Outcomes
Primary outcome [1] 329902 0
Inspiratory muscle strength will be assessed as maximal inspiratory pressure (cmH2O) using a portable MicroRPM Respiratory Pressure meter (CareFusion, San Diego, USA).
Timepoint [1] 329902 0
Measures of inspiratory muscle strength will be recorded at baseline assessment and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [1] 404203 0
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) section II will be used to assess the impact of Parkinson's disease on activities of daily living.

Timepoint [1] 404203 0
Measures of daily living activities will be recorded at baseline and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [2] 404204 0
Exercise capacity will be assessed using the 6-minute walk test, and the longest distance walked (m) measured using a tape measure after the 6 minutes.
Timepoint [2] 404204 0
Measures of walking distance will be recorded at baseline and and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [3] 404788 0
Heart rate (BPM) during 6-minute walk test as assessed with chest strap monitor.
Timepoint [3] 404788 0
Measures of BPM will be recorded at baseline assessment and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [4] 404789 0
Blood pressure (mmHg) during 6-minute walk test as assessed with sphygmomanometer.
Timepoint [4] 404789 0
Measures of blood pressure will be recorded at baseline assessment and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [5] 404790 0
Dyspnoea and overall fatigue during 6-minute walk test as assessed using the modified Borg scale.
Timepoint [5] 404790 0
Measures of dyspnoea and overall fatigue will be recorded at baseline assessment and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [6] 404791 0
Peripheral oxygen saturation (SpO2) during 6-minute walk test as assessed with finger pulse oximeter.
Timepoint [6] 404791 0
Measures of SpO2 will be recorded at baseline assessment and after 8 weeks by a trained assessor blinded to group allocation.
Secondary outcome [7] 404792 0
Quality of life will be measured using the 39-item Parkinson's disease Questionnaire (PDQ-39).
Timepoint [7] 404792 0
Measures of quality of life will be completed at baseline and after 8 weeks by a trained assessor blinded to group allocation.

Eligibility
Key inclusion criteria
People with idiopathic Parkinson's disease will asked for consent to participate in the trial. They will also need to have stable Parkison's disease medications, answer ‘yes’ to a question about having ever had trouble with their breathing, and should be able to walk independently with or without usual walking aids.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants should not have uncontrolled chronic or acute cardiovascular (e.g., angina, heart failure) and/or respiratory disease (e.g., asthma, pulmonary oedema) or other neurological conditions (e.g., neuromuscular diseases). Participants will not have undertaken any type of breathing training in the last six months or medical conditions which would preclude or interfere with the assessment or the training program. (i.e., rib fracture, risk of pneumothorax).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealled allocation will be managed by administrative staff at the research site unconnected with the study and accessible to the investigators.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation for the study will be provided through a computer-generated random number sequence.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was calculated for the primary outcome measure maximal inspiratory pressure (MIP). To detect a 17 cm H2O change in MIP with a power of 0.80, 50 participants are required, allowing a sample loss of about 20% due to dropout. (Unpublished local data, 2021) Although the minimal clinically important difference in MIP scores has not been established in this patient group, the 17 cmH2O change level was selected based on the most recent study of inspiratory muscle strength in older outpatients with chronic obstructive pulmonary disease. (Iwakura M, et al. Estimation of minimal clinically important difference for quadriceps and inspiratory muscle strength in older outpatients with chronic obstructive pulmonary disease: a prospective cohort study. Phys Ther Res. 2021;24(1):35-42)

Descriptive statistics will be performed and presented as mean (± standard deviation) or median (interquartile range) and 95% confidence intervals. For variables with parametric distribution, the paired t-tests will be used to assess between group changes. Mixed linear models will be used to assess the between-group difference of the changes between enrolment and follow-up measures. A 95% confidence interval will be used to establish any differences and a p-value <0.05 will be indicative of a statistically significant difference between groups (two-tailed). If the supposition of normality is not met, pairwise comparisons between groups will be performed using a nonparametric test, as appropriate, for independent samples or dependent samples.

The qualitative data will be explored through analysis of the interview data. Audio-recordings of the interviews will be transcribed verbatim. NVivo12 will be used to assist in the process of data analysis, and thematic analysis will guide interpretation of the data. Data collected from each interview will be validated by submitting a data analysis summary to participants for comments.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/01/2022
Actual
24/03/2022
Date of last participant enrolment
Anticipated
3/02/2023
Actual
Date of last data collection
Anticipated
4/04/2023
Actual
Sample size
Target
50
Accrual to date
22
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment postcode(s) [1] 36230 0
2617 - University Of Canberra

Funding & Sponsors
Funding source category [1] 310383 0
University
Name [1] 310383 0
University of Canberra
Country [1] 310383 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari Street,
Bruce ACT 2617 Australia
Country
Australia
Secondary sponsor category [1] 311548 0
None
Name [1] 311548 0
Address [1] 311548 0
Country [1] 311548 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310036 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 310036 0
Ethics committee country [1] 310036 0
Australia
Date submitted for ethics approval [1] 310036 0
09/09/2021
Approval date [1] 310036 0
13/12/2021
Ethics approval number [1] 310036 0
9268

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

Contacts
Principal investigator
Name 116266 0
Mrs Juliana Fernandes Barreto de Mendonca
Address 116266 0
University of Canberra Hospital
Level 2, Guraguma Street, Bruce ACT 2617
Country 116266 0
Australia
Phone 116266 0
+61 426250217
Fax 116266 0
Email 116266 0
[email protected]
Contact person for public queries
Name 116267 0
Juliana Fernandes Barreto de Mendonca
Address 116267 0
University of Canberra Hospital
Level 2, Guraguma Street, Bruce ACT 2617
Country 116267 0
Australia
Phone 116267 0
+61 426250217
Fax 116267 0
Email 116267 0
[email protected]
Contact person for scientific queries
Name 116268 0
Juliana Fernandes Barreto de Mendonca
Address 116268 0
University of Canberra Hospital
Level 2, Guraguma Street, Bruce ACT 2617
Country 116268 0
Australia
Phone 116268 0
+61 426250217
Fax 116268 0
Email 116268 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
Data sharing was not included in ethical approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14451Ethical approval  [email protected] [email protected]



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.