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

26. října 2016 aktualizováno: 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.

Přehled studie

Postavení

Ukončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

5

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené království
    • Hampshire
      • Portsmouth, Hampshire, Spojené království, PO1 2ER
        • University of Portsmouth - Department of Sport and Exercise Science

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

35 let až 90 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Inspiratory Warm Up
(IWU). Two sets of 15 breaths
Jiný: Inspiratory Warm Up
Inspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
Experimentální: Expiratory Warm Up
(EWU). Two sets of 15 breaths
Jiný: Expiratory Warm Up
Expiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
Experimentální: Combination Warm Up
(RWU). One set of 15 breaths inspiratory and one set of 15 breaths expiratory
Jiný: Combination Warm Up
Combination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
Jiný: Control Trial
No warm up
Jiný: Control Trial
Control Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Distance walked in the 6 minute walk test
Časové okno: 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
Časové okno: 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
Časové okno: 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).

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Heart rate (HR)
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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).

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Portsmouth

Vyšetřovatelé

  • Vrchní vyšetřovatel: Craig Williamson, MSc, PhD Research Student

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. února 2016

Primární dokončení (Aktuální)

1. října 2016

Dokončení studie (Aktuální)

1. října 2016

Termíny zápisu do studia

První předloženo

13. srpna 2015

První předloženo, které splnilo kritéria kontroly kvality

20. srpna 2015

První zveřejněno (Odhad)

25. srpna 2015

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

27. října 2016

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

26. října 2016

Naposledy ověřeno

1. října 2016

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • RWU-01

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NE

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