The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02532075
• Other study ID #: RWU-01
• Status: Terminated
• Phase: N/A
• First received: August 13, 2015
• Last updated: October 26, 2016
• Start date: February 2016
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: University of Portsmouth
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Other:
• Inspiratory Warm Up
Inspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
• Expiratory Warm Up
Expiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
• Combination Warm Up
Combination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
• Control Trial
Control Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials.

Locations

Country	Name	City	State
United Kingdom	University of Portsmouth - Department of Sport and Exercise Science	Portsmouth	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance walked in the 6 minute walk test		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).	No
Primary	Rating of perceived exertion (RPE) in the 6 minute walk test	Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.	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).	No
Primary	Rating of dyspnoea during the six minute walk test	Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.	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).	No
Secondary	Heart rate (HR)	Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.	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).	No
Secondary	Expired gas	Measured from a few minutes prior to the six minute walk test until 20 minutes post test (or until VO2 returns to baseline following test). A brief gap in measurement will occur 5 minutes test to allow for a measure of pulmonary function.	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).	No
Secondary	Peripheral arterial oxygen saturation (SpO2)	Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.	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).	No
Secondary	Pulmonary function: maximal inspiratory mouth pressure (MIP)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: maximal expiratory mouth pressure (MEP)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: specific airway resistance (sRaw)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: airway resistance (Raw)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: functional residual capacity (FRCpleth)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: peak inspiratory flow (PIF)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: peak expiratory flow (PEF)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: forced expiratory volume in one second (FEV1)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: forced vital capacity (FVC)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: residual volume (RV)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: tidal volume (VT)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: total lung capacity (TLC)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: inspiratory residual volume (IRV)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: expiratory residual volume (ERV)	Note: only if body plethysmography is available. Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: inspiratory capacity (IC)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No
Secondary	Pulmonary function: inspiratory vital capacity (IVC)	Measured pre respiratory warm up, post respiratory warm up and post 6 minute walk test (control trial will only be measured pre and post exercise test).	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).	No