Clinical trial NCT02532075: The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease
Official title: The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Respiratory Muscle Warm Up
Lead sponsor: University of Portsmouth
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 5
Sex: ALL
Minimum age (years): 35
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distance walked in the 6 minute walk test
timeFrame: 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).
measure: Rating of perceived exertion (RPE) in the 6 minute walk test
timeFrame: 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).
measure: Rating of dyspnoea during the six minute walk test
timeFrame: 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).
Secondary outcomes:
measure: Heart rate (HR)
timeFrame: 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).
measure: Expired gas
timeFrame: 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).
measure: Peripheral arterial oxygen saturation (SpO2)
timeFrame: 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).
measure: Pulmonary function: maximal inspiratory mouth pressure (MIP)
timeFrame: 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).
measure: Pulmonary function: maximal expiratory mouth pressure (MEP)
timeFrame: 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).
measure: Pulmonary function: specific airway resistance (sRaw)
timeFrame: 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).
measure: Pulmonary function: airway resistance (Raw)
timeFrame: 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).
measure: Pulmonary function: functional residual capacity (FRCpleth)
timeFrame: 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).
measure: Pulmonary function: peak inspiratory flow (PIF)
timeFrame: 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).
measure: Pulmonary function: peak expiratory flow (PEF)
timeFrame: 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).
measure: Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
timeFrame: 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).
measure: Pulmonary function: forced expiratory volume in one second (FEV1)
timeFrame: 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).
measure: Pulmonary function: forced vital capacity (FVC)
timeFrame: 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).
measure: Pulmonary function: residual volume (RV)
timeFrame: 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).
measure: Pulmonary function: tidal volume (VT)
timeFrame: 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).
measure: Pulmonary function: total lung capacity (TLC)
timeFrame: 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).
measure: Pulmonary function: inspiratory residual volume (IRV)
timeFrame: 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).
measure: Pulmonary function: expiratory residual volume (ERV)
timeFrame: 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).
measure: Pulmonary function: inspiratory capacity (IC)
timeFrame: 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).
measure: Pulmonary function: inspiratory vital capacity (IVC)
timeFrame: 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).
Other outcomes:
Locations:
city: Portsmouth
country: United Kingdom
facility: University of Portsmouth - Department of Sport and Exercise Science
state: Hampshire
Study officials:
affiliation: PhD Research Student
name: Craig Williamson, MSc
role: PRINCIPAL_INVESTIGATOR
References: