- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00037973
Effect of Ventilation-Feedback Training on Exercise Performance in COPD
Effects of Ventilation-Feedback Training on Exercise Performance in COPD
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Statement of the Problem: Chronic obstructive pulmonary disease (COPD) is a term used to characterize those individuals with chronic bronchitis or emphysema who have obstruction to airflow on a spirogram. 1) Patients with COPD have a poor exercise capacity that is reflective of their underlying disease. 2) The symptoms of lung disease triggered by simple low-intensity activities of daily living such as dressing and undressing, bathing and shopping are insufferable, consequently these patients become sedentary. An increasingly sedentary lifestyle leads to muscle deconditioning making physical activity even more intolerable. 3) The cycle continues in a downward spiral. Pulmonary rehabilitation is essential to assist persons with COPD to cope with their disease. The two primary objectives of pulmonary rehabilitation are to control and alleviate the symptoms of the respiratory illness and to assist the patient toward optimal capabilities in carrying out his/her activities of daily living. 4) The proposed study will evaluate the efficacy of a unique program of ventilation-feedback training combined with leg-cycle and walking exercise to improve exertional endurance, perceived dyspnea and quality of life in persons with COPD.
Hypothesis: Individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill constant work rate (CWR) exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training or a ventilation-feedback training only program.
Specific Objectives:
Short-term Objectives- The primary objective of the proposed study is to determine whether individuals with COPD who complete 12-weeks of ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training program will demonstrate significantly longer exercise duration on the treadmill CWR exercise test when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program without ventilation-feedback or a ventilation-feedback program only. The secondary objectives of the proposed research are to determine whether individuals with COPD who complete ventilation-feedback training combined with a moderately-high intensity exercise and upper body strength training or ventilation-feedback only program will, when compared to subjects who are randomly assigned to a moderately-high intensity exercise and upper body strength training program only, demonstrate significantly: (a) greater work tolerance and aerobic power on maximal leg-cycle and treadmill exercise tests; (b) lower perception of breathlessness during progressive and CWR leg-cycle and treadmill exercise tests; (c) significantly higher tidal volume (VT) and lower breathing frequency during CWR and at any given workload on the progressive leg-cycle and treadmill exercise tests; (d) lower score on the Chronic Respiratory Disease Questionnaire (CRDQ)5 indicating better quality of life; and (e) higher transition focal score on the Transition Dyspnea Index (TDI).6 In addition, six weeks after completing the training program all subjects will repeat the treadmill CWR test. This will be done to assess whether the positive effects of the ventilation-feedback training persist beyond the 12-week training period.
Long-term Objectives: If our hypothesis is correct, we will use the ventilation-feedback technique to teach a more efficient breathing pattern during activities of daily living. In time, the system will be miniaturized and portable thereby making this new technique readily usable during pulmonary rehabilitation.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Illinois
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Hines, Illinois, États-Unis, 60141-5000
- Edward Hines, Jr. VA Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
Patients with chronic obstructive pulmonary disease
Exclusion Criteria:
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: 2
Exercer
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Expérimental: 1
Ventilation-feedback plus exercise
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Comparateur actif: 3
ventilation feedback only
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Exercise endurance
Délai: 12 weeks
|
12 weeks
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- F2302
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