Pulmonary Disease, Chronic ObstructiveNCT01956565
Feasibility of Inspiratory Muscle Training in People With COPD Who Decline Pulmonary Rehabilitation
A study testing Inspiratory Muscle training in people with Pulmonary Disease, Chronic Obstructive, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The feasibility study will involve mixed methods, this means interviews as well as assessment of treatment with inspiratory muscle training therapy (IMT). There are two pathways within the study depending on whether people want to have inspiratory muscle training. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Inspiratory Muscle training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People over the age of 35
- with stable COPD (having had no exacerbation needing antibiotics or steroids in the preceding four weeks) with breathlessness on Medical Research Council (MRC) scale of 3 or above who decline Pulmonary rehabilitation (MRC 3 is defined as "walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace").
Who cannot join
- History of spontaneous pneumothorax
- incomplete recovery from a traumatic pneumothorax
- asthma
- known recently perforated eardrum
- unstable angina
- ventricular dysrhythmias
- cerebral event or myocardial infarction within the last two months
- not oral antibiotics or steroids for COPD exacerbation within the last four weeks
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Community Services, Sheffield Teaching Hospitals
Sheffield, South Yorkshire, S5 6NU
About this study
Official title: Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation
The feasibility study will involve mixed methods, this means interviews as well as assessment of treatment with inspiratory muscle training therapy (IMT). There are two pathways within the study depending on whether people want to have inspiratory muscle training. People who accept to have inspiratory muscle training will have assessments before training, after 8 weeks of training and at 6 month follow up in addition to interviews before and after the study (at 6 months). For those who choose not to have the inspiratory muscle training the investigators will offer them an interview so that the investigators can find out more about what might have made the study more appealing or what treatments they would have preferred. The investigators will also ask if they wish to be followed up with baseline assessments for the study period and if the investigators can access health records.
Interviews
Read more
Semi-structured interviews lasting approximately an hour will be performed at the beginning of the study with participants who accept the IMT pathway and those who decline IMT until no knew themes are raised. These interviews will be used to provide information on reasons for declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment preferences and opinions regarding study design and outcome measures (see Interview Topic guide). The interviews will be taped and transcribed verbatim. A follow up interview with study participants who have received IMT will be conducted at 6 months addressing attitudes to IMT and study design and whether they have decided that they wish to engage with other services (such as pulmonary rehabilitation and smoking cessation).
Inspiratory Muscle Training (IMT) method
Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax). This means that each breath in through the device is set at 60% of the maximum force you are able to create when you breathe in rather than at full force. 30 breaths are performed at high velocity (paced initially over a period of 15 minutes to allow recovery between each breath through the device). Once established it is anticipated that each training session should take no more than five minutes. Training is performed twice a day, 5 days per week for the first 8 weeks. Training will be titrated (set to a level suitable for the participant) and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Inspiratory Muscle training
- Keywords
- Pulmonary Disease, Chronic Obstructive, Rehabilitation, Physiotherapy, Patient Compliance, Inspiratory Muscle Training, Respiratory Muscle Training
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle trainingOther
Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax) with 30 breaths at high velocity (paced initially over a period of 15 minutes), twice a day, 5 days per week. Tidal breathing without inspiratory resistance is acceptable for recovery between each high velocity breath. Training will be titrated and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Inspiratory muscle training | Experimental | Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax) with 30 breaths at high velocity (paced initially over a period of 15 minutes), twice a day, 5 days per week. Tidal breathing without inspiratory resistance is acceptable for recovery between each high velocity breath. Training will be titrated and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks. Receives: Other: Inspiratory Muscle training |
| Declining Inspiratory muscle training | No intervention | No intervention. Interview and baseline assessment only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.
Measured: 4 months
Secondary outcomes (4)
Adherence with Inspiratory muscle training
Adherence to IMT: measured using a customised electronic threshold device (Powerbreathe) recording data from baseline to 6 months. Adherence will also be assessed using participant diaries.
Measured: 6 months
Attrition rate.
Attrition rate over the 6 month course of treatment.
Measured: 6 months
Maximal inspiratory pressure (PiMax)
Inspiratory muscle strength: Maximal inspiratory pressure (PiMax) and Sniff Nasal pressure measured using the MicroRPM (Micromedical) at baseline, 8 weeks and 6 months.
Measured: Baseline, 8 weeks, 6 months
Acceptability
Acceptability of IMT, study design and outcome measures and engagement or intention to engage with other services will be addressed in interviews at baseline and at 6 months for participants. A single interview will be offered to those declining the IMT arm of the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJun 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01956565
- Sponsor's protocol ID
- STH 16453
- Status last verified
- Apr 2016
- First submitted
- 30 Sep 2013
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
O'Connor C, Lawson R, Waterhouse J, Mills GH. Is inspiratory muscle training (IMT) an acceptable treatment option for people with chronic obstructive pulmonary disease (COPD) who have declined pulmonary rehabilitation (PR) and can IMT enhance PR uptake? A single-group prepost feasibility study in a home-based setting. BMJ Open. 2019 Aug 8;9(8):e028507. doi: 10.1136/bmjopen-2018-028507.
PubMed 31399454
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation
- ClinicalTrials.gov ID
- NCT01956565
- Acronym / sponsor ID
- STH 16453
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Rehabilitation, Physiotherapy, Patient Compliance, Inspiratory Muscle Training, Respiratory Muscle Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The feasibility study will involve mixed methods, this means interviews as well as assessment of treatment with inspiratory muscle training therapy (IMT). There are two pathways within the study depending on whether people want to have inspiratory muscle training. People who accept to have inspiratory muscle training will have assessments before training, after 8 weeks of training and at 6 month follow up in addition to interviews before and after the study (at 6 months). For those who choose not to have the inspiratory muscle training the investigators will offer them an interview so that the investigators can find out more about what might have made the study more appealing or what treatments they would have preferred. The investigators will also ask if they wish to be followed up with baseline assessments for the study period and if the investigators can access health records.
Interviews
Semi-structured interviews lasting approximately an hour will be performed at the beginning of the study with participants who accept the IMT pathway and those who decline IMT until no knew themes are raised. These interviews will be used to provide information on reasons for declining pulmonary rehabilitation, attitudes to exercise, attitudes to IMT, treatment preferences and opinions regarding study design and outcome measures (see Interview Topic guide). The interviews will be taped and transcribed verbatim. A follow up interview with study participants who have received IMT will be conducted at 6 months addressing attitudes to IMT and study design and whether they have decided that they wish to engage with other services (such as pulmonary rehabilitation and smoking cessation).
Inspiratory Muscle Training (IMT) method
Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax). This means that each breath in through the device is set at 60% of the maximum force you are able to create when you breathe in rather than at full force. 30 breaths are performed at high velocity (paced initially over a period of 15 minutes to allow recovery between each breath through the device). Once established it is anticipated that each training session should take no more than five minutes. Training is performed twice a day, 5 days per week for the first 8 weeks. Training will be titrated (set to a level suitable for the participant) and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inspiratory muscle training | Experimental | Other: Inspiratory Muscle trainingParticipants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax) with 30 breaths at high velocity (paced initially over a period of 15 minutes), twice a day, 5 days per week. Tidal breathing without inspiratory resistance is acceptable for recovery between each high velocity breath. Training will be titrated and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks. |
| Declining Inspiratory muscle training | No intervention | –No intervention. Interview and baseline assessment only. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- People over the age of 35
- with stable COPD (having had no exacerbation needing antibiotics or steroids in the preceding four weeks) with breathlessness on Medical Research Council (MRC) scale of 3 or above who decline Pulmonary rehabilitation (MRC 3 is defined as "walks slower than contemporaries on level ground because of breathlessness, or has to stop for breath when walking at own pace").
Key exclusion criteria (8 listed)
- History of spontaneous pneumothorax
- incomplete recovery from a traumatic pneumothorax
- asthma
- known recently perforated eardrum
- unstable angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory Muscle trainingParticipants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax) with 30 breaths at high velocity (paced initially over a period of 15 minutes), twice a day, 5 days per week. Tidal breathing without inspiratory resistance is acceptable for recovery between each high velocity breath. Training will be titrated and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks. | Other | Inspiratory muscle training |
Primary outcome
Recruitment
Time frame: 4 months
Recruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.
4 secondary outcomes
Adherence with Inspiratory muscle training
Time frame: 6 months
Attrition rate.
Time frame: 6 months
Maximal inspiratory pressure (PiMax)
Time frame: Baseline, 8 weeks, 6 months
Acceptability
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Derived from this study: PubMed 31399454O'Connor C, Lawson R, Waterhouse J, Mills GH. Is inspiratory muscle training (IMT) an acceptable treatment option for people with chronic obstructive pulmonary disease (COPD) who have declined pulmonary rehabilitation (PR) and can IMT enhance PR uptake? A single-group prepost feasibility study in a home-based setting. BMJ Open. 2019 Aug 8;9(8):e028507. doi: 10.1136/bmjopen-2018-028507.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle training in people with Pulmonary Disease, Chronic Obstructive, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01956565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016; AzTrials last refreshed its copy on 8 Nov 2026.