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

NCT02532075 | Terminated

• 1 other identifier: RWU-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Respiratory Muscle Warm Up

Outcome Measures

Primary Outcomes (3)

• 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).

• 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).

• 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).

Secondary Outcomes (20)

• 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).

Study Arms (4)

Inspiratory Warm Up

EXPERIMENTAL

(IWU). Two sets of 15 breaths

Other: Inspiratory Warm Up

Expiratory Warm Up

EXPERIMENTAL

(EWU). Two sets of 15 breaths

Other: Expiratory Warm Up

Combination Warm Up

EXPERIMENTAL

(RWU). One set of 15 breaths inspiratory and one set of 15 breaths expiratory

Other: Combination Warm Up

Control Trial

OTHER

No warm up

Other: Control Trial

Interventions

Inspiratory Warm Up OTHER

Inspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung.

Inspiratory Warm Up

Expiratory Warm Up OTHER

Expiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung.

Expiratory Warm Up

Combination Warm Up OTHER

Combination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling.

Combination Warm Up

Control Trial OTHER

Control Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials.

Control Trial

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Portsmouth: lead

Study Sites (1)

University of Portsmouth - Department of Sport and Exercise Science

Portsmouth, Hampshire, PO1 2ER, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Craig Williamson, MSc

  PhD Research Student

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Research Student

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 25, 2015
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)