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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01956565
• Other study ID #: STH 16453
• Status: Completed
• Phase: N/A
• First received: September 30, 2013
• Last updated: April 13, 2016
• Start date: June 2014
• Est. completion date: October 2015

Study information

• Verified date: April 2016
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Community Services, Sheffield Teaching Hospitals	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related quality of life (HRQOL)	HRQOL measured using the Chronic Respiratory Disease questionnaire (CRQ) and COPD Assessment Test.	Baseline, 8 weeks, 6 months	No
Other	Anxiety and depression	Anxiety and depression measured using the Hospital Anxiety and Depression Questionnaire.	Baseline, 8 weeks, 6 months	No
Other	Activity Monitory	Activity monitoring assessed using Sensewear Accelerometers (Sensewear Pro-Armband Bodymedia) worn for four days.	Baseline, 8 weeks, 6 months	No
Other	Dyspnoea	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.	Baseline, 8 weeks, 6 months	No
Other	Healthcare utilisation	Healthcare utilisation measured using patient diaries and electronic health records, and EQ5DL.	6 months	No
Primary	Recruitment	Recruitment of 10 participants for inspiratory muscle training and 10 participants for interview alone within a four month period.	4 months	No
Secondary	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.	6 months	No
Secondary	Attrition rate.	Attrition rate over the 6 month course of treatment.	6 months	No
Secondary	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.	Baseline, 8 weeks, 6 months	No
Secondary	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.	6 months	No