Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000938909p
Ethics application status
Submitted, not yet approved
Date submitted
8/07/2020
Date registered
21/09/2020
Date last updated
21/09/2020
Date data sharing statement initially provided
21/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of inspiratory muscle training in Parkinson's disease
Scientific title
Feasibility and acceptability of inspiratory muscle training in Parkinson's disease
Secondary ID [1] 301679 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
 318122 0
Dyspnoea 318512 0
Condition category
Condition code
Neurological 316145 316145 0 0
Parkinson's disease
Respiratory 316720 316720 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Given the uncertainty of the global health situation over the next 18 months, we will describe face to face and telehealth approaches and use the approach according to current guidelines.

We plan to recruit participants who are already attending group classes at the University of Canberra Student Led Neurological Rehabilitation Clinic. Currently (July 2020), these participants are participating in classes face-to-face and via telehealth. We propose to provide the participants the option of participating either via telehealth, or in person in the clinic whilst remaining inline with all public health recommendations. Given the degree of uncertainty of the global health situation over the next 18 months, we have outlined protocols for either face to face or telehealth to facilitate conducting this research in line with public health recommendations and patient preferences.

If face-to-face consultations are allowed there will be an initial consultation with the participants whereby their maximal inspiratory pressure will be determined. This is an indirect measure of their inspiratory muscle strength and involves inhaling forcefully through a hand-held pressure metre 3 times (described in more detail below). We will also measure each participant’s grip strength as this has been found to be a useful predictor of health factors including mortality, disability and prolonged hospitalisation in other populations. At initial consultation we will also perform a quality of life questionnaire (PDQ-39), demographic survey and Borg dyspnoea scale. The aforementioned measures will be performed by an assessor blinded to the research’s outcomes.

Following these measures, a different research officer will then demonstrate how the participant’s training program will work, explain how to set up their training device and the protocol to follow. We will also provide a written outline of the training schedule, and this will also function as a ‘diary’ where they can enter their daily training levels, adherence and any adverse events. In total, we anticipate the baseline measurement and protocol set-up appointment to take approximately half an hour.

If restrictions allow respiratory muscle testing, Maximum Inspiratory Pressure testing will be performed with MicroRPM Respiratory Pressure Meter and testing will follow the American Thoracic Society’s guidelines for testing. This is a non-invasive procedure whereby the participant will be seated, instructed to breathe out as far as they can until they “empty their lungs”. They will then seal their mouth around the mouthpiece, either pinch their nose or use or a nose peg, and take one quick, hard and fast breath in. This will initially be shown to the participant by the assessor before performing the test themselves. The test will be repeated 2 more times, with breaks allowed in between – the participant will lead as to when they are ready to perform the next test. The best reading of 3 will be taken. Total procedure time will take less than 5 minutes.

If restrictions do not allow face-to-face consultation, we propose to do initial consult via telehealth. These patients are currently participating in exercise classes through the clinic’s telehealth service, so we do not see this being a concern for participants. Instead of a direct measure of maximum inspiratory pressure, we will use the inspiratory muscle training device to determine an appropriate training load with verbal guidance from the research team. Initial questionnaires will be done over the telehealth consult, and training will continue as per training protocol. All required training devices and diaries will be delivered to participant’s home prior to commencement.

After the initial consultation, participants will be left to train in their own time, recording training in a diary, with weekly check ins with the research team (via telehealth / phone call) to adjust training levels, answer questions and provide continuation of training. Participants will need to set their device to the predetermined pressure level (at 50% maximal inspiratory pressure), and do six inspiratory breaths, 5 times over - taking 15-20 minutes. Participants will perform this 5 days per week for 6 weeks. Training intensity will be discussed and adjusted weekly as necessary based on participant tolerability. Participants should find this to be of a moderate level of exertion and be able to ‘just’ complete 6th breath in each set. Intervention training will be provided to participants by a Physiotherapy student under the supervision of an experienced Physiotherapist.

After 6 weeks training there will be a final appointment with participants. This will be to gather information on acceptability, gather their training diaries and do a final measure of maximal inspiratory pressure (if appointment is face to face, and test is permitted), quality of life, Borg Dyspnoea scale and grip strength (if face to face). Again, these measures will be performed by an assessor blinded to the outcomes of the study, and will take approximately half an hour per participant.
Intervention code [1] 318005 0
Rehabilitation
Intervention code [2] 318389 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324352 0
Feasibility of inspiratory muscle training. This will be measured by: number of participants screened, number of participants enrolled, time taken to prescribe (assessed via clinical notes), adherence to training (via participant diary), time taken to follow up (total time taken over training protocol as assessed via clinical notes), number of participants completed intervention protocol, adverse events (assessed via patient diary and clinical notes - examples include shortness of breath, cough, dizziness, fatigue, muscle soreness).
Timepoint [1] 324352 0
Baseline, and after 6 weeks of inspiratory muscle training.
Primary outcome [2] 324857 0
Acceptability of inspiratory muscle training. This will be measured via structured likert questionnaire, created specifically for this study.
Timepoint [2] 324857 0
After 6 weeks of inspiratory muscle training
Secondary outcome [1] 384421 0
Grip strength using hand grip dynamometer
Timepoint [1] 384421 0
Baseline and after 6 weeks of intervention training
Secondary outcome [2] 384422 0
Maximal inspiratory pressure using microRPM respiratory pressure meter
Timepoint [2] 384422 0
Baseline and after 6 weeks of intervention training
Secondary outcome [3] 384423 0
Quality of Life (PDQ39)
Timepoint [3] 384423 0
Baseline and after 6 weeks of intervention training
Secondary outcome [4] 384424 0
Dyspnoea (Borg Dyspnoea Scale)
Timepoint [4] 384424 0
Baseline and after 6 weeks of intervention training

Eligibility
Key inclusion criteria
Idiopathic Parkinson's Disease, medication stability, and answering ‘yes’ to having ever had trouble with their breathing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-idiopathic Parkinson’s Disease, mini mental <24 and sessional exclusion will include medication in ‘off’ phase as well as any contraindications for inspiratory muscle training

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The primary research question is whether inspiratory muscle training is a) feasible in and b) acceptable to patients with Parkinson's disease who are already attending an exercise clinic.

The secondary research questions is whether there are any identifiable factors associated with inspiratory muscle weakness in patients with Parkinson’s disease already attending an exercise clinic.

Initial baseline data will be collected at initial consultation whether that be via telehealth or in person at the clinic. Post intervention data will be collected via telehealth or in person at the clinic, as well as gathering data on adherence and training levels from their training diary.

Demographic data will be presented using descriptive analysis. Baseline measures of inspiratory muscle strength (MIP) will be presented as absolute values (cmH2O) as well as percentage predicted values using normalised equations which account for each patient’s age and gender. Proportion of patients with inspiratory muscle weakness (determined a priori as MIP <60% predicted value) will be described as a percentage of the cohort studied. In determining whether there is a relationship between inspiratory muscle strength and other factors, univariate analysis and multivariate analysis will be used to describe relationships between maximal inspiratory pressure and perception of dyspnoea, quality of life and grip strength. All data analysis will be done via consultation with a statistician.

Feasibility of recruitment will be determined by number of participants screened, eligible and enrolled. Feasibility of intervention will be determined by measuring time taken to prescribe exercise program, proportion of planned sessions completed, time taken on weekly phone consultations, number of adverse events and acceptability survey results. Feasibility of measurement will be measured by time taken to assess participants pre and post intervention, and any adverse events. Acceptability will be reported using means and standard deviations of the likert scores on the acceptability survey.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT

Funding & Sponsors
Funding source category [1] 306115 0
University
Name [1] 306115 0
University of Canberra
Country [1] 306115 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari Street, Bruce, ACT, 2617
Country
Australia
Secondary sponsor category [1] 306604 0
None
Name [1] 306604 0
Address [1] 306604 0
Country [1] 306604 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 306334 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 306334 0
Ethics committee country [1] 306334 0
Australia
Date submitted for ethics approval [1] 306334 0
03/07/2020
Approval date [1] 306334 0
Ethics approval number [1] 306334 0

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

Contacts
Principal investigator
Name 103530 0
Mrs Abbie Doherty
Address 103530 0
University of Canberra, 11 Kirinari Street, Bruce, ACT, 2617
Country 103530 0
Australia
Phone 103530 0
+61 468373866
Fax 103530 0
Email 103530 0
[email protected]
Contact person for public queries
Name 103531 0
Abbie Doherty
Address 103531 0
University of Canberra, 11 Kirinari Street, Bruce, ACT, 2617
Country 103531 0
Australia
Phone 103531 0
+61 468373866
Fax 103531 0
Email 103531 0
[email protected]
Contact person for scientific queries
Name 103532 0
Abbie Doherty
Address 103532 0
University of Canberra, 11 Kirinari Street, Bruce, ACT, 2617
Country 103532 0
Australia
Phone 103532 0
+61 468373866
Fax 103532 0
Email 103532 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
IPD not covered by ethical clearance


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8402Informed consent form    380118-(Uploaded-08-07-2020-12-31-36)-Study-related document.docx
8403Ethical approval  [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.