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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01956565
Recruitment Status : Completed
First Posted : October 8, 2013
Last Update Posted : April 14, 2016
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Other: Inspiratory Muscle training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Feasibility of Inspiratory Muscle Training in People With Chronic Obstructive Pulmonary Disease (COPD) Who Decline Pulmonary Rehabilitation
Study Start Date : June 2014
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Rehabilitation

Arm Intervention/treatment
Experimental: Inspiratory 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.
Other: Inspiratory 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.

No Intervention: Declining Inspiratory muscle training
No intervention. Interview and baseline assessment only.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01956565


Locations
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United Kingdom
Community Services, Sheffield Teaching Hospitals
Sheffield, South Yorkshire, United Kingdom, S5 6NU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01956565    
Other Study ID Numbers: STH 16453
First Posted: October 8, 2013    Key Record Dates
Last Update Posted: April 14, 2016
Last Verified: April 2016
Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
Pulmonary Disease, Chronic Obstructive
Rehabilitation
Physiotherapy
Patient Compliance
Inspiratory Muscle Training
Respiratory Muscle Training
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Aspiration
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive
Respiration Disorders