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- Klinische proef NCT02532075
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Hampshire
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Portsmouth, Hampshire, Verenigd Koninkrijk, PO1 2ER
- University of Portsmouth - Department of Sport and Exercise Science
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Gerandomiseerd
- Interventioneel model: Faculteitstoewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Inspiratory Warm Up
(IWU). Two sets of 15 breaths
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Inspiratory muscle warm up.
Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
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Experimenteel: Expiratory Warm Up
(EWU). Two sets of 15 breaths
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Expiratory muscle warm up.
Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
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Experimenteel: Combination Warm Up
(RWU).
One set of 15 breaths inspiratory and one set of 15 breaths expiratory
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Combination of inspiratory and expiratory muscle warm up.
One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
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Ander: Control Trial
No warm up
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Control Trial.
No respiratory muscle warm up to act as a comparison to the other three intervention trials.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Distance walked in the 6 minute walk test
Tijdsspanne: 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).
|
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
Tijdsspanne: 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).
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Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
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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).
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Rating of dyspnoea during the six minute walk test
Tijdsspanne: 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).
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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).
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Heart rate (HR)
Tijdsspanne: 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).
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Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
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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).
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Expired gas
Tijdsspanne: 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).
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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).
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Peripheral arterial oxygen saturation (SpO2)
Tijdsspanne: 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).
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Measured from 1 minute pre 6 minute walk test to cessation of the test and at 60 metre intervals throughout.
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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).
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Pulmonary function: maximal inspiratory mouth pressure (MIP)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: maximal expiratory mouth pressure (MEP)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: specific airway resistance (sRaw)
Tijdsspanne: 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).
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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).
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Pulmonary function: airway resistance (Raw)
Tijdsspanne: 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).
|
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).
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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).
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Pulmonary function: functional residual capacity (FRCpleth)
Tijdsspanne: 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).
|
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).
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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).
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Pulmonary function: peak inspiratory flow (PIF)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: peak expiratory flow (PEF)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: forced expiratory volume in one second (FEV1)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: forced vital capacity (FVC)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: residual volume (RV)
Tijdsspanne: 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).
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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).
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Pulmonary function: tidal volume (VT)
Tijdsspanne: 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).
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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).
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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).
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Pulmonary function: total lung capacity (TLC)
Tijdsspanne: 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).
|
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).
|
Pulmonary function: inspiratory residual volume (IRV)
Tijdsspanne: 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).
|
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).
|
Pulmonary function: expiratory residual volume (ERV)
Tijdsspanne: 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).
|
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).
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Pulmonary function: inspiratory capacity (IC)
Tijdsspanne: 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).
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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).
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Pulmonary function: inspiratory vital capacity (IVC)
Tijdsspanne: 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 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).
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Craig Williamson, MSc, PhD Research Student
Studie record data
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Studie start
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Studieregistratiedata
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Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
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Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- RWU-01
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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