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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Inspiratory Muscle training
Sponsored by
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Rehabilitation, Physiotherapy, Patient Compliance, Inspiratory Muscle Training, Respiratory Muscle Training

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Community Services, Sheffield Teaching Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Inspiratory muscle training

Declining Inspiratory muscle training

Arm Description

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.

No intervention. Interview and baseline assessment only.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Attrition rate.
Attrition rate over the 6 month course of treatment.
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.
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.

Full Information

First Posted
September 30, 2013
Last Updated
April 13, 2016
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01956565
Brief Title
Feasibility of Inspiratory Muscle Training in People With COPD Who Decline Pulmonary Rehabilitation
Official Title
Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Rehabilitation, Physiotherapy, Patient Compliance, Inspiratory Muscle Training, Respiratory Muscle Training

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inspiratory muscle training
Arm Type
Experimental
Arm Description
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.
Arm Title
Declining Inspiratory muscle training
Arm Type
No Intervention
Arm Description
No intervention. Interview and baseline assessment only.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle training
Intervention Description
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 Outcome Measure Information:
Title
Recruitment
Description
Recruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Adherence with Inspiratory muscle training
Description
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.
Time Frame
6 months
Title
Attrition rate.
Description
Attrition rate over the 6 month course of treatment.
Time Frame
6 months
Title
Maximal inspiratory pressure (PiMax)
Description
Inspiratory muscle strength: Maximal inspiratory pressure (PiMax) and Sniff Nasal pressure measured using the MicroRPM (Micromedical) at baseline, 8 weeks and 6 months.
Time Frame
Baseline, 8 weeks, 6 months
Title
Acceptability
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Health related quality of life (HRQOL)
Description
HRQOL measured using the Chronic Respiratory Disease questionnaire (CRQ) and COPD Assessment Test.
Time Frame
Baseline, 8 weeks, 6 months
Title
Anxiety and depression
Description
Anxiety and depression measured using the Hospital Anxiety and Depression Questionnaire.
Time Frame
Baseline, 8 weeks, 6 months
Title
Activity Monitory
Description
Activity monitoring assessed using Sensewear Accelerometers (Sensewear Pro-Armband Bodymedia) worn for four days.
Time Frame
Baseline, 8 weeks, 6 months
Title
Dyspnoea
Description
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.
Time Frame
Baseline, 8 weeks, 6 months
Title
Healthcare utilisation
Description
Healthcare utilisation measured using patient diaries and electronic health records, and EQ5DL.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Community Services, Sheffield Teaching Hospitals
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 6NU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31399454
Citation
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.
Results Reference
derived

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

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