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Feasibility of Inspiratory Muscle Training in People With COPD Who Decline Pulmonary Rehabilitation

Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01956565
Enrollment
10
Registered
2013-10-08
Start date
2014-06-30
Completion date
2015-10-31
Last updated
2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive, Rehabilitation, Physiotherapy, Patient Compliance, Inspiratory Muscle Training, Respiratory Muscle Training

Brief 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. 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.

Interventions

OTHERInspiratory Muscle training

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.

Sponsors

Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Recruitment4 monthsRecruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.

Secondary

MeasureTime frameDescription
Adherence with Inspiratory muscle training6 monthsAdherence 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.
Attrition rate.6 monthsAttrition rate over the 6 month course of treatment.
Maximal inspiratory pressure (PiMax)Baseline, 8 weeks, 6 monthsInspiratory muscle strength: Maximal inspiratory pressure (PiMax) and Sniff Nasal pressure measured using the MicroRPM (Micromedical) at baseline, 8 weeks and 6 months.
Acceptability6 monthsAcceptability 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.

Other

MeasureTime frameDescription
Health related quality of life (HRQOL)Baseline, 8 weeks, 6 monthsHRQOL measured using the Chronic Respiratory Disease questionnaire (CRQ) and COPD Assessment Test.
Anxiety and depressionBaseline, 8 weeks, 6 monthsAnxiety and depression measured using the Hospital Anxiety and Depression Questionnaire.
Activity MonitoryBaseline, 8 weeks, 6 monthsActivity monitoring assessed using Sensewear Accelerometers (Sensewear Pro-Armband Bodymedia) worn for four days.
DyspnoeaBaseline, 8 weeks, 6 monthsDyspnoea measured using the first 5 questions of the CRQ. Dyspnoea will also be measured by the modified BORG breathlessness score recorded pre and post IMT.
Healthcare utilisation6 monthsHealthcare utilisation measured using patient diaries and electronic health records, and EQ5DL.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026