- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04879576
The Effects of Telerehabilitation in Patients With COPD (COPD)
The Effects of Telerehabilitation on Respiratory Functions, Quality of Life, Exercise Capacity, Fatigue and Psychosocial Factors in Patients With COPD
Chronic Obstructive Pulmonary Disease is a serious public health problem worldwide and it is a leading cause of mortality and morbidity. Nowadays, COPD patients are increasing in all societies and the problems that arise during the life of these patients increase the need for care and rehabilitation. Pulmonary rehabilitation has proven to be the best supportive treatment for individuals with COPD. However, there are difficulties in rehabilitation practices in terms of the fragility of patients, transportation and access problems. Telerehabilitation allows patients who cannot access rehabilitation due to their geographical, economic or physical disabilities to benefit from rehabilitation services. There are different studies demonstrating the effect of telerehabilitation in COPD patients and confirming that it is safe, but it is a developing area and has a limited area of use.
In this randomized controlled study, it is aimed to examine the effect of telerehabilitation training on respiratory functions, exercise capacity, quality of life, fatigue and psychosocial factors in individuals with COPD via video conferencing including respiratory exercises and postural exercises.
Aperçu de l'étude
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Beyza Karakaş
- Numéro de téléphone: 05062187342
- E-mail: beyzakarakas071@gmail.com
Lieux d'étude
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Kırıkkale, Turquie
- Recrutement
- Kırıkkale High Specialization Hospital
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Contact:
- Selma Demir
- Numéro de téléphone: 05054895758
- E-mail: drmed64@gmail.com
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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:
- Having been diagnosed with chronic obstructive pulmonary disease according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- Not having an attack in the last 2 months
- Volunteering to participate in the study
- Being between the ages of 40-80
- To have a device that can be used in telerehabilitation application and an active internet connection.
Exclusion Criteria:
- Unstable angina, previous myocardial infarction, severe congestive heart failure resistant to medical therapy, uncontrolled hypertension, cancer, neurological or musculoskeletal disorders with functional limitations
- Currently addicted to alcohol or drugs
- Having an injury to the lower extremity such as sprains, sprains or fractures in the last 6 months, not being able to perform independent ambulation
- Having serious vision and hearing problems
- Having severe cognitive impairment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Aucune intervention: Groupe de contrôle
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Expérimental: Groupe de traitement
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Telerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from Baseline in respiratory functions on the spirometry at week 8
Délai: Baseline - Week 8
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Spirometry is a standard test doctors use to measure how well your lungs are functioning.
The test works by measuring airflow into and out of your lungs.Spirometry measures two key factors: expiratory forced vital capacity (FVC) and forced expiratory volume in one second (FEV1).
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Baseline - Week 8
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Change from Baseline in exercise capacity on six-minute walk test at week 8
Délai: Baseline - Week 8
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The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.
The goal is for the individual to walk as far as possible in six minutes.A lower score (reflecting less distance covered in 6 minutes) indicates worse function.
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Baseline - Week 8
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Change from Baseline in health-related quality of life on Saint George's Respiratory Questionnaire at week 8
Délai: Baseline - Week 8
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Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.Scores range from 0 to 100, with higher scores indicating more limitations.
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Baseline - Week 8
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Change from Baseline in psychosocial factors on Beck Depression and Beck Anxiety Inventory at week 8
Délai: Baseline - Week 8
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Beck Depression Inventory is a self-assessment scale that determines the risk of individuals in terms of depression and measures the level of depressive symptoms and the change in severity.Beck Anxiety Inventory is a likert type self-assessment scale that determines the frequency of anxiety symptoms experienced by individuals.
The high score the individual gets from the scale indicates the severity of anxiety experienced.
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Baseline - Week 8
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Change from Baseline in fatigue on COPD and Asthma Fatigue Scale at week 8
Délai: Baseline - Week 8
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The COPD and Asthma Fatigue Scale , was developed for use in clinical trials and other studies in respiratory diseases.
The COPD and Asthma Fatigue Scale was intended to be sufficiently comprehensive to capture fatigue experienced by patients with either asthma or COPD, yet be brief and patient centered.
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Baseline - Week 8
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change from Baseline in dyspnea on Modified Medical Research Council Dyspnea Scale at week 8
Délai: Baseline - Week 8
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The modified Medical Research Council (mMRC) scale is the most commonly used validated scale to assess dyspnea in daily living in chronic respiratory diseases.
It is a scale scored between 0 and 5 based on various factors causing dyspnea.
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Baseline - Week 8
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Meral Sertel, Associate professor at Kırıkkale University
- Directeur d'études: Beyza Karakaş, Graduate student at Kırıkkale University
- Chercheur principal: Selma Demir, Chest Diseases Specialist at Kırıkkale High Specialization Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- KKUniversity
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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