The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease
26 oktober 2016 uppdaterad av: Craig Williamson, University of Portsmouth
The Effect of a Respiratory Muscle Warm-up Prior to Exercise in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
5
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Hampshire
-
Portsmouth, Hampshire, Storbritannien, PO1 2ER
- University of Portsmouth - Department of Sport and Exercise Science
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 90 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Inspiratory Warm Up
(IWU). Two sets of 15 breaths
|
Inspiratory muscle warm up.
Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
|
|
Experimentell: Expiratory Warm Up
(EWU). Two sets of 15 breaths
|
Expiratory muscle warm up.
Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
|
|
Experimentell: Combination Warm Up
(RWU).
One set of 15 breaths inspiratory and one set of 15 breaths expiratory
|
Combination of inspiratory and expiratory muscle warm up.
One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
|
|
Övrig: Control Trial
No warm up
|
Control Trial.
No respiratory muscle warm up to act as a comparison to the other three intervention trials.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Distance walked in the 6 minute walk test
Tidsram: 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
Tidsram: 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 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
Tidsram: 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 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).
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Heart rate (HR)
Tidsram: 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 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).
|
|
Expired gas
Tidsram: 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 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).
|
|
Peripheral arterial oxygen saturation (SpO2)
Tidsram: 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 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).
|
|
Pulmonary function: maximal inspiratory mouth pressure (MIP)
Tidsram: 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).
|
|
Pulmonary function: maximal expiratory mouth pressure (MEP)
Tidsram: 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).
|
|
Pulmonary function: specific airway resistance (sRaw)
Tidsram: 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: airway resistance (Raw)
Tidsram: 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: functional residual capacity (FRCpleth)
Tidsram: 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: peak inspiratory flow (PIF)
Tidsram: 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).
|
|
Pulmonary function: peak expiratory flow (PEF)
Tidsram: 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).
|
|
Pulmonary function: forced expiratory flow at 25, 50 and 75% maximal vital capacity) (FEF 25, 50, 75)
Tidsram: 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).
|
|
Pulmonary function: forced expiratory volume in one second (FEV1)
Tidsram: 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).
|
|
Pulmonary function: forced vital capacity (FVC)
Tidsram: 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).
|
|
Pulmonary function: residual volume (RV)
Tidsram: 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: tidal volume (VT)
Tidsram: 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).
|
|
Pulmonary function: total lung capacity (TLC)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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 capacity (IC)
Tidsram: 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).
|
|
Pulmonary function: inspiratory vital capacity (IVC)
Tidsram: 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).
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Craig Williamson, MSc, PhD Research Student
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 februari 2016
Primärt slutförande (Faktisk)
1 oktober 2016
Avslutad studie (Faktisk)
1 oktober 2016
Studieregistreringsdatum
Först inskickad
13 augusti 2015
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2015
Första postat (Uppskatta)
25 augusti 2015
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
27 oktober 2016
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 oktober 2016
Senast verifierad
1 oktober 2016
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RWU-01
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .