Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001129279
Ethics application status
Approved
Date submitted
8/11/2017
Date registered
10/07/2018
Date last updated
10/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of an 8- week home based inspiratory muscle training program on inspiratory muscle strength in healthy adults: a feasibility study
Scientific title
Effects of an 8- week home based inspiratory muscle training
program on insipratory muscle strength in healthy adults: a
feasibility study
Secondary ID [1] 295088 0
Nil
Universal Trial Number (UTN)
U1111-1215-1890
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inspiratory muscle weakness 305288 0
Condition category
Condition code
Respiratory 304646 304646 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research project will involve the trial of a non-invasive intervention aimed at strengthening the muscles involved in inhalation. The intervention will be conducted in participant’s homes and will be 8 weeks in duration. Inspiratory muscle training (IMT) uses a portable IMT device that provides a resistance to the flow of air into the lungs. This causes the muscles of inspiration to contract with a greater force to deliver more air into the lungs, potentially resulting in increases in muscle strength. The training program will be conducted independently in participant's homes and will include 10 minutes of breathing exercises in the morning and 10 minutes again in the evening, every second day to total 20 minutes of breathing exercises per training day. Each allocated 10 minute training session will include 3 sets of 10 breaths with a break in between each set. The initial training load will be set to 60% of maximum inspiratory pressure as measured in the pre-testing period, for participants in the high intensity (H-IMT) training group. For participants in the sham group (S-IMT) training loads will set at a minimum level as to not induce any training effect. Progression of the training loads for both groups will be conducted during the weekly telephone appointment with the research assistant. Each participant will be given a training diary to take home that will record the date, duration, rate of perceived exertion (RPE), level of satisfaction and any comments they might have for each training session. The training diaries will be returned to the research team at the conclusion of the training program.
For those participants in the H-IMT, training loads will be increased based on what score the participant recorded for their RPE using the Modified Borg Dyspnoea Scale for their last training session. Participants who recorded less than or equal to 2 will increase resistance on their IMT device by one full revolution, and participants who recorded an RPE of 3-4 will increase resistance on their device by a half turn. For all participants undergoing S-IMT training, resistance will be increased by a 1/4 turn on the device each week.
Intervention code [1] 299540 0
Rehabilitation
Intervention code [2] 301423 0
Treatment: Devices
Comparator / control treatment
Participants will be randomly allocated to a high intensity IMT program (H-IMT) or a sham inspiratory muscle-training group (S-IMT). Randomisation to a H-IMT or S-IMT will be done using online software (http//www.randomization.com).
Control group
Placebo

Outcomes
Primary outcome [1] 303870 0
Primary feasibility objective: compliance

Compliance will be measured by the number completed training sessions over the number of prescribed training sessions. Minimum satisfactory compliance will be 80% of all prescribed training sessions completed (45 sessions completed out of a total of 56 over the 8 week period).
Timepoint [1] 303870 0
8 weeks after randomization
Primary outcome [2] 303896 0
Primary feasibility objective: satisfaction

Satisfaction will be measured using a 5-point scale: very satisfied (5), satisfied (4), neutral (3), dissatisfied (2) and very dissatisfied (1). The training program is deemed to be satisfactory if the participant records either 'very satisfied' or 'satisfied' for at least 80% of all training session.
Timepoint [2] 303896 0
8 weeks after randomization
Secondary outcome [1] 340380 0
Secondary feasibility objective: time commitment

Even though the estimated training time commitment has been set by the researchers we will investigate the exact time commitment recorded (in minutes) that it takes to perform the required training dosage.
Timepoint [1] 340380 0
8 weeks after randomization
Secondary outcome [2] 347714 0
Secondary feasibility objective: cost

We will investigate the cost (in dollars) in order to complete the training program.

Cost will be assessed by taking into account the price of the IMT devices, cost for testing equipment and cost incurred by participants to travel to and from the testing facility.
Timepoint [2] 347714 0
8 weeks after randomization

Eligibility
Key inclusion criteria
Target population will be a sample of healthy adults ranging from 20-65 years with equal representation of participants within each age-group decade.
Inclusion criteria: Participants (aged 20-65 years). An ability to read, understand and converse in English is required
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Participants who have significant cardiopulmonary or musculoskeletal conditions, which make them unsuitable for testing or IMT training, will be excluded. Participants will be excluded if experiencing an acute respiratory conditions such as infection, asthma exacerbation etc. Participants currently enrolled in other research projects, as well as non-English speaking participants will be excluded from the study. Any participant that smokes, or has quit within the past year, will be excluded from the study. Participants also suffering from a ruptured eardrum or any other adverse condition of the ear that will impact use of the IMT device will be excluded. Participant’s blood oxygen levels must remain higher than 94% during the introductory training session. Those whose blood oxygen levels fall below 94% will be excluded from the study.

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)
Allocation concealment was carried out using central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The method of concealed random allocation will be conducted using randomisation software at: www.randomization.com
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data Analysis
Exercise diaries will be collected and data entered into SPSS (IBM Corp. Released 2016. IBM SPSS Statistics for Windows, Version 24.0. Armonk, NY: IBM Corp) for analysis. Descriptive statistics will be calculated and comparisons between pre and post intervention parameters after H-IMT and S-IMT explored.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
25/03/2018
Date of last participant enrolment
Anticipated
Actual
7/07/2018
Date of last data collection
Anticipated
12/09/2018
Actual
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 22869 0
6014 - Floreat

Funding & Sponsors
Funding source category [1] 297936 0
University
Name [1] 297936 0
University of Notre Dame, Fremantle
Country [1] 297936 0
Australia
Primary sponsor type
University
Name
University of Notre Dame, Fremantle
Address
32 Mouat St, Fremantle WA 6160
Country
Australia
Secondary sponsor category [1] 299001 0
None
Name [1] 299001 0
Address [1] 299001 0
Country [1] 299001 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298920 0
University of Notre Dame Fremantle Human Research Ethics Committee
Ethics committee address [1] 298920 0
32 Mouat St, Fremantle WA 6160
Ethics committee country [1] 298920 0
Australia
Date submitted for ethics approval [1] 298920 0
07/11/2017
Approval date [1] 298920 0
15/01/2018
Ethics approval number [1] 298920 0
017187F

Summary
Brief summary
Research question: Does an 8-week home-based high intensity inspiratory muscle training (H-IMT) program affect inspiratory muscle strength in healthy adults?

Hypothesis (feasibility objectives):
To test the feasibility of an 8-week home-based H-IMT program in healthy adults in regards to compliance and satisfaction

Aims - feasibility
This study aims to explore the feasibility of an 8-week home-based H-IMT program with regard to participant compliance and satisfaction levels. Compliance will be measured by the number of completed training sessions and satisfaction will be measured using a 5 point-scale in reference to the participant’s sense of well-being. Good compliance is defined as completing 80% of the total number of training sessions over the 8-week period. This equates to completing a minimum of 45 of the total 56 sessions. The satisfaction 5 point-scale will include the following options: very satisfied, satisfied, neutral, dissatisfied and very dissatisfied. The intervention will be deemed to be satisfactory from the participant’s point of view if they circle 4 (satisfied) or 5 (very satisfied) for at least 80% all training sessions. Feasibility consideration will extend to investigating the time commitment required by participants for completing assessments and intervention, along with the financial cost of delivering the intervention. Time per training session will be recorded and cost estimates will be calculated for the duration of the intervention period.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78650 0
Miss Stephanie Brooks
Address 78650 0
University of Notre Dame, Fremantle
School of Physiotherapy
Cnr of High and Mouat Streets (Entrance Mouat Street)
Fremantle WA 6160
Country 78650 0
Australia
Phone 78650 0
+61414458311
Fax 78650 0
Email 78650 0
[email protected]
Contact person for public queries
Name 78651 0
A/Prof Shane Patman
Address 78651 0
32 Mouat St, Fremantle WA 6160
University of Notre Dame, Fremantle
School of Physiotherapy
Country 78651 0
Australia
Phone 78651 0
+61 8 9433 0204
Fax 78651 0
Email 78651 0
[email protected]
Contact person for scientific queries
Name 78652 0
Prof Shane Patman
Address 78652 0
32 Mouat St, Fremantle WA 6160
University of Notre Dame, Fremantle
School of Physiotherapy
Country 78652 0
Australia
Phone 78652 0
+61414458311
Fax 78652 0
Email 78652 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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