None listed
Conditions
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.
Interventions
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 muscl
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.
Sponsors
University of Notre Dame, Fremantle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed