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Completed

NCT Number: NCT01956565

Feasibility of Inspiratory Muscle Training in People With 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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Services, Sheffield Teaching Hospitals

Sheffield, South Yorkshire, S5 6NU, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Inspiratory Muscle Training

Other

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.

Primary outcomes

  1. Recruitment

    Time frame: 4 months

    Recruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.

Secondary outcomes

  1. Adherence with Inspiratory muscle training

    Time frame: 6 months

    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.

  2. Attrition rate.

    Time frame: 6 months

    Attrition rate over the 6 month course of treatment.

  3. Maximal inspiratory pressure (PiMax)

    Time frame: Baseline, 8 weeks, 6 months

    Inspiratory muscle strength: Maximal inspiratory pressure (PiMax) and Sniff Nasal pressure measured using the MicroRPM (Micromedical) at baseline, 8 weeks and 6 months.

  4. Acceptability

    Time frame: 6 months

    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.

Other outcomes

  1. Health related quality of life (HRQOL)

    Time frame: Baseline, 8 weeks, 6 months

    HRQOL measured using the Chronic Respiratory Disease questionnaire (CRQ) and COPD Assessment Test.

  2. Anxiety and depression

    Time frame: Baseline, 8 weeks, 6 months

    Anxiety and depression measured using the Hospital Anxiety and Depression Questionnaire.

  3. Activity Monitory

    Time frame: Baseline, 8 weeks, 6 months

    Activity monitoring assessed using Sensewear Accelerometers (Sensewear Pro-Armband Bodymedia) worn for four days.

  4. Dyspnoea

    Time frame: Baseline, 8 weeks, 6 months

    Dyspnoea 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.

  5. Healthcare utilisation

    Time frame: 6 months

    Healthcare utilisation measured using patient diaries and electronic health records, and EQ5DL.

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2013
Registry last updated
Apr 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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