Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD

16. mai 2017 oppdatert av: Zhujiang Hospital

Effects of Combined Cycle Training and Inspiratory Muscle Training on Exercise Performance ,Health-related Quality,Dyspnoea ,Body Composition,Depressive Symptomatology in Patients With Chronic Obstructive Pulmonary Disease(COPD)

Chronic Obstructive Pulmonary Disease (COPD) ，the fourth leading cause of death in the world, represents an important public health challenge. It is also a major cause of chronic morbidity, mortality and disability throughout the world, leading to a heavy social and economic burden. For a long time, treatment of COPD mainly focus on drug therapy. Recently, pulmonary rehabilitation is recognized as a core component of the management of individuals with chronic respiratory disease, which has been clearly demonstrated to reduce dyspnea, increase exercise capacity, and improve quality of life.

Exercise training, widely regarded as the cornerstone of pulmonary rehabilitation , is one of the best available means of improving muscle function in COPD.The most commonly form is cycle training. Inspiratory Muscle Training (IMT) as an adjunct to exercise training has an additional benefit on inspiratory muscle strength, endurance and exercise capacity in patient with COPD.

There is insufficient evidence demonstrate greater benefits from combined inspiratory muscle training and cycle training. This study will evaluate the effects of combined inspiratory muscle training and cycle training in patients with COPD.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The patients with COPD will participate in a rehabilitation program for 8 weeks. Participants in the proposed study will be randomly programmed into one of three intervention groups:

  1. Cycle training program alone (performing on calibrated stationary cycle ergometer).
  2. Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
  3. Neither cycle training nor inspiratory muscle training.

Studietype

Intervensjonell

Registrering (Faktiske)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Kina
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510282
        • Zhujiang Hospital,Southern Medical Universtiy

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 75 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients between 40 and 75 years of age were eligible if they met the following criteria:

    • moderate to severe airflow obstruction (30≤ Forced Expiratory Volume At One Second(FEV1) <80% predicted and Forced Expiratory Volume At One Second/Forced Vital Capacity(FEV1/FVC)<70%)
    • Complaints of dyspnea on exertion
    • Clinically stable condition
    • No participation in a pulmonary rehabilitation program in the last year.

Exclusion Criteria:

  • Patients were excluded if they had evidence of asthma and/or had experienced a major exacerbation in the 2 months before enrollment
  • Required home oxygen therapy or experienced oxyhemoglobin desaturation below 85% with exercise
  • And/or had other health problems that would interfere with exercise.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kontrollgruppe
Verken sykkeltrening eller inspiratorisk muskeltrening.
Enhet: Kontrollgruppe
Verken sykkeltrening eller inspiratorisk muskeltrening.
Eksperimentell: Cycle training group
A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
Enhet: calibrated cycle ergometer
The most common device to proform cycle training is calibrated cycle ergometer.
Eksperimentell: Combined group
A 30-minute Combined training session is performed 3 days a week using calibrated cycle ergometer and threshold loading device.
Enhet: calibrated cycle ergometer and threshold loading device
Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Exercise Performance (composite outcome measure)
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Exercise performance tests include field walking tests and cycle ergometer tests.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Health-related quality (composite outcome measure)
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Health-related quality is a component of the broader concept of quality of life and is defined as satisfaction with health.The St. George's Respiratory Questionnaire (SGRQ) and Chronic Respiratory Disease Questionnaire (CRQ）; and its self-reported version are the most widely used disease-specific questionnaires.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
inspiratory muscle function (composite outcome measure)
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Currently, a variety of methods can be used to evaluate respiratory muscle function, including maximal inspiratory (PImax)，expiratory pressures(PEmax) and inspiratory muscle endurance.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Symptom Evaluation (composite outcome measure)
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Individuals with chronic respiratory disease often have symptoms such as dyspnea, fatigue, cough, weakness, sleeplessness,and psychological distress.Instruments for assessment of multiple symptoms include COPD Assessment Test (CAT) and Modified Medical British Research Council Scale(mMRC).
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Depression and anxiety evaluation
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Hospital Anxiety and Depression Scale (HADS) was found to perform well in assessing the symptom severity and caseness of anxiety disorders and depression in both somatic, psychiatric and primary care patients and in the general population.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Composite outcomes
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Among patients with COPD there is increasing interest in the use of multidimensional indices to characterize the severity of the disease and better predict outcomes.Arguably the most well-known of these indices is the BODE Index.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Body Composition Monitor
Tidsramme: The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)
Body composition abnormalities are prevalent in COPD.Human body composition analyzer can detect various elements of human body and analyze human health status.
The groups will be assessed at baseline (time zero) and at the end of the training protocol (week 8)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Zhujiang Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. desember 2014

Primær fullføring (Faktiske)

1. januar 2017

Studiet fullført (Faktiske)

1. januar 2017

Datoer for studieregistrering

Først innsendt

20. juli 2014

Først innsendt som oppfylte QC-kriteriene

24. juli 2014

Først lagt ut (Anslag)

25. juli 2014

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. mai 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

16. mai 2017

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CX13902205193

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Kontrollgruppe

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Slovenia

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere