The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Portsmouth
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Distance walked in the 6 minute walk test
Study Overview
Brief Summary
The purpose of this study is to investigate the effects of performing a breathing muscle warm up before exercise in patients who have chronic obstructive pulmonary disease (COPD). The main aim is to see whether performing a breathing muscle warm up can improve distance walked in a 6 minute walk test and also decrease perceptions of effort and breathlessness.
Detailed Description
The study will follow a counter-balanced repeated measures design involving six visits to the exercise laboratory. Following pre-screening and familiarisation (visits 1 and 2), participants will perform inspiratory warm up, expiratory warm up, combination warm up and control trials (visits 3 - 6) in a counter-balanced order separated by at least 48 hours between trials.
The four separate sessions will contain: lung function measurements assessed by performing breathing manoeuvres through a mouthpiece (spirometery or body plethysmography) before performing a breathing muscle warm up by breathing against a resistance through a small handheld device (PowerLung). Participants will then be asked perform a second set of lung function measurements and will then be asked to perform a 6 minute walk test wearing a face mask and a portable device (gas analysis), a small device clipped to a finger (pulse oximeter) and wearing a heart rate monitor. During this 6 minute walk test participants will also be asked to rate their perceived effort and level of breathlessness at 60m intervals. Following the test there will be a period of seated rest wearing the face mask and portable device for up to 20 minutes with one more set of lung function measurements.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Masking
- None
Eligibility Criteria
- Ages
- 35 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A clinical diagnosis of COPD
- •Aged between 35 and 90 years
- •Able to fluently read and speak English
- •Willing and able to sign informed consent
- •Be able to comply with the procedures outlined for the study
Exclusion Criteria
- •Cardiac disease (including arrhythmias)
- •A medicinal requirement for rate limiting calcium antagonists or beta blockers
- •Cerebrovascular disease
- •Peripheral vascular disease
- •Requirement for supplemental oxygen therapy
- •CO2 (carbon dioxide) retention
- •Malignancy
- •Orthopaedic or neurological conditions effecting the ability to exercise
- •Clinically apparent heart failure
- •Renal, hepatic or inflammatory disease
- •Instability of COPD
- •Any other reason leading to the inability to complete the requirements of the study.
- •Additionally: If participants have a resting HR above 120beats.min-1, systolic blood pressure above 180mm Hg or diastolic blood pressure above 100mm Hg prior to the 6 minute walk test they will not be able to commence the test.
Arms & Interventions
Inspiratory Warm Up
(IWU). Two sets of 15 breaths
Intervention: Inspiratory Warm Up (Other)
Expiratory Warm Up
(EWU). Two sets of 15 breaths
Intervention: Expiratory Warm Up (Other)
Combination Warm Up
(RWU). One set of 15 breaths inspiratory and one set of 15 breaths expiratory
Intervention: Combination Warm Up (Other)
Control Trial
No warm up
Intervention: Control Trial (Other)
Outcomes
Primary Outcomes
Distance walked in the 6 minute walk test
Time Frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Rating of perceived exertion (RPE) in the 6 minute walk test
Time Frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Rating of dyspnoea during the six minute walk test
Time Frame: Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).
Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
Secondary Outcomes
- Heart rate (HR)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Expired gas(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Peripheral arterial oxygen saturation (SpO2)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: maximal inspiratory mouth pressure (MIP)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: maximal expiratory mouth pressure (MEP)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: specific airway resistance (sRaw)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: airway resistance (Raw)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: functional residual capacity (FRCpleth)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: peak inspiratory flow (PIF)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: peak expiratory flow (PEF)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: forced expiratory volume in one second (FEV1)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: forced vital capacity (FVC)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: residual volume (RV)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: tidal volume (VT)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: total lung capacity (TLC)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: inspiratory residual volume (IRV)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: expiratory residual volume (ERV)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: inspiratory capacity (IC)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
- Pulmonary function: inspiratory vital capacity (IVC)(Estimate is 4 weeks per participant to complete all trials. Measured during each trail that is expected to last 1-2 hours. (Trial format is described elsewhere).)
Investigators
Craig Williamson
PhD Research Student
University of Portsmouth