- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02200549
Effects of Combined Cycle Training and Inspiratory Muscle Training in Patients With COPD
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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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:
- Cycle training program alone (performing on calibrated stationary cycle ergometer).
- Combined cycle training and inspiratory muscle training(performing on calibrated stationary cycle ergometer and threshold loading device).
- Neither cycle training nor inspiratory muscle training.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510282
- Zhujiang Hospital,Southern Medical Universtiy
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Kontrollgruppe
Weder Fahrradtraining noch inspiratorisches Muskeltraining.
|
Weder Fahrradtraining noch inspiratorisches Muskeltraining.
|
Experimental: Cycle training group
A 30-minute cycling training session is performed 3 days a week using calibrated cycle ergometer.
|
The most common device to proform cycle training is calibrated cycle ergometer.
|
Experimental: Combined group
A 30-minute Combined training session is performed 3 days a week using 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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Exercise Performance (composite outcome measure)
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Health-related quality (composite outcome measure)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Depression and anxiety evaluation
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CX13902205193
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Kontrollgruppe
-
Acibadem UniversityAbgeschlossenPfleger-Patienten-BeziehungenTruthahn
-
Columbia UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...AbgeschlossenSchlafen | Asthma | Asthma bei KindernVereinigte Staaten
-
U.S. Army Medical Research and Development CommandUnited States Agency for International Development (USAID); University of Oxford und andere MitarbeiterAbgeschlossen
-
Hui-Hsun ChiangAbgeschlossenErziehungsprobleme | Pflege | Gewalt am ArbeitsplatzTaiwan
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutierungEmpfängnisverhütung | Nutzung des Gesundheitswesens | Verwendung von VerhütungsmittelnVereinigte Staaten
-
University of Illinois at ChicagoPatient-Centered Outcomes Research Institute; University of ChicagoRekrutierungSchwangerschaftskomplikationen | Patientenbindung | Muster der mütterlichen FürsorgeVereinigte Staaten
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalAbgeschlossen
-
Universitat Jaume IAbgeschlossenDepression | AngststörungenSpanien
-
Cairo UniversityNoch keine Rekrutierung
-
Northwestern UniversityAbgeschlossen