- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Guangdong
-
Guangzhou, Guangdong, Cina, 510282
- Zhujiang Hospital,Southern Medical Universtiy
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Gruppo di controllo
Né l'allenamento in bicicletta né l'allenamento dei muscoli inspiratori.
|
Né l'allenamento in bicicletta né l'allenamento dei muscoli inspiratori.
|
Sperimentale: 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.
|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Exercise Performance (composite outcome measure)
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Health-related quality (composite outcome measure)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Depression and anxiety evaluation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CX13902205193
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Gruppo di controllo
-
University of Sao Paulo General HospitalTRB ChemedicaCompletatoOsteoartrite | Artrosi al ginocchioBrasile
-
Sandra BucciUniversity of Edinburgh; NHS Lothian; Manchester University NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust e altri collaboratoriCompletatoAbusi sessuali su minori, confermati, sequelRegno Unito
-
M.D. Anderson Cancer CenterCompletatoTumori pediatriciStati Uniti
-
University of California, Los AngelesCompletatoDiabete di tipo 2Stati Uniti
-
Rush University Medical CenterCompletato
-
University of LisbonAssociacao Protectora dos Diabeticos de PortugalCompletato
-
Kara MarlattCompletatoMenopausa | Condizioni correlate alla menopausaStati Uniti
-
Greater Manchester Mental Health NHS Foundation...Manchester University NHS Foundation Trust; University of Manchester; Anna Freud... e altri collaboratoriCompletatoProblema di salute mentaleRegno Unito
-
Sunnybrook Health Sciences CentreRitiratoIl focus dello studio è sugli atteggiamenti del dentista nei confronti delle misurazioni della pressione arteriosaCanada
-
Ohio State UniversityNon ancora reclutamentoInvecchiamento | Focus GroupStati Uniti