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

16 maj 2017 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

90

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

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

40 år till 75 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Kontrollgrupp
Varken cykelträning eller inspirerande muskelträning.
Enhet: Kontrollgrupp
Varken cykelträning eller inspirerande muskelträning.
Experimentell: 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.
Experimentell: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Exercise Performance (composite outcome measure)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Health-related quality (composite outcome measure)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Depression and anxiety evaluation
Tidsram: 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
Tidsram: 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
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Zhujiang Hospital

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 december 2014

Primärt slutförande (Faktisk)

1 januari 2017

Avslutad studie (Faktisk)

1 januari 2017

Studieregistreringsdatum

Först inskickad

20 juli 2014

Först inskickad som uppfyllde QC-kriterierna

24 juli 2014

Första postat (Uppskatta)

25 juli 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 maj 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

16 maj 2017

Senast verifierad

1 mars 2016

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CX13902205193

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

Nej

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