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

NCT ID: NCT02532075

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-10-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Pulmonary Disease

Keywords

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COPD Respiratory Muscle Warm Up

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

NONE

Study Groups

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Inspiratory Warm Up

(IWU). Two sets of 15 breaths

Group Type EXPERIMENTAL

Inspiratory Warm Up

Intervention Type OTHER

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

Expiratory Warm Up

(EWU). Two sets of 15 breaths

Group Type EXPERIMENTAL

Expiratory Warm Up

Intervention Type OTHER

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

Combination Warm Up

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

Group Type EXPERIMENTAL

Combination Warm Up

Intervention Type OTHER

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

Control Trial

No warm up

Group Type OTHER

Control Trial

Intervention Type OTHER

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

Interventions

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Inspiratory Warm Up

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

Intervention Type OTHER

Expiratory Warm Up

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

Intervention Type OTHER

Combination Warm Up

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

Intervention Type OTHER

Control Trial

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Portsmouth

OTHER

Sponsor Role lead

Responsible Party

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Craig Williamson

PhD Research Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Craig Williamson, MSc

Role: PRINCIPAL_INVESTIGATOR

PhD Research Student

Locations

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University of Portsmouth - Department of Sport and Exercise Science

Portsmouth, Hampshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RWU-01

Identifier Type: -

Identifier Source: org_study_id