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Home-monitoring and Adherence of Patients With COPD to Long-term Rehabilitation

14 avril 2015 mis à jour par: Alda Sofia Pires de Dias Marques, Aveiro University

The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation

The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD.

Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

Patients with Chronic Obstructive Pulmonary Disease (COPD) present lower levels of physical activity (PA), which have been associated with increased healthcare utilization and reduced survival. Thus, optimizing PA levels has become one therapeutic priority in COPD management.

Pulmonary rehabilitation (PR) is an effective intervention in reducing symptoms and improving patients' functional status and quality of life. However, its effects in increasing patients' physical activity (PA) levels are limited. Previous research has suggested that PR with continuous PA monitoring with feedback may be a suitable approach to increase and maintain patients' PA levels.

Patients who agree to participate will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). Both PR programs will last 12 weeks and consist of exercise training and psychoeducation sessions. During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.

The impact of the intervention will be explored using a mixed-methods approach.

Assessments will be conducted in both groups at 4 time points: before, immediately after, 3 and 6 months after the PR program. Physical activity levels, lung function, breathlessness, exercise tolerance, peripheral muscle strength, health-related quality of life and healthcare utilization will be assessed in both groups in these time points.

Descriptive statistics will be used to characterize the sample. To analyze changes in outcome measures, data from the two groups will be compared at each time point.

Patients in the EG will also be invited to attend focus groups after the intervention to assess their perspective about the intervention and their satisfaction with the use of the pedometer.

A sample size calculation using the primary outcome was performed based in a previous pilot study. It was found that 12 patients with COPD would be required in each group to provide 80% power (alpha = 0.05) to detect significant differences between groups. However, as PR programs usually have considerable dropouts (around 30%), 16 patients with COPD were recruited for each group.

Type d'étude

Interventionnel

Inscription (Réel)

32

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Le Portugal
      • Aveiro, Le Portugal, 3810-193
        • University of Aveiro

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
  • ≥ 18 years old
  • clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)
  • able to provide their own informed consent

Exclusion Criteria:

  • inability to understand and co-operate
  • presence of severe psychiatric conditions
  • presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease
  • participation in regular strenuous exercise (e.g., greater than 10 hours per week of running, swimming, weightlifting or any other similar physical activity) prior to the study

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Groupe de contrôle
Comportemental: Pulmonary rehabilitation (PR)
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week).
Expérimental: Groupe expérimental
Comportemental: Pulmonary rehabilitation (PR) plus PA monitoring and feedback from a pedometer
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week). Patients will also receive a pedometer to self-monitor their PA during and after the PR program and individualized step-count goals.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in physical activity levels
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.
1 week before, 1 week after, 3 and 6 months after the PR program

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in exercise tolerance
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
Exercise tolerance will be assessed with the 6-minute walk test, following the American Thoracic Society guidelines. The maximal distance walked during 6 minutes and the associated respiratory symptoms will be collected.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in peripheral muscle strength
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
Isometric muscle strength of the upper and lower limbs will be assessed with the 1 repetition maximum (1-RM), following the American College of Sports Medicine guidelines.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in activities limitation resulting from breathlessness
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
The Modified British Medical Research Council questionnaire comprises five grades (statements) in a scale from 0 to 4, with higher grades indicating greater perceived respiratory limitation.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in behavioral regulations in exercise
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
The Behavioural Regulation in Exercise Questionnaire-2 (BRES-2) is a 19-item instrument designed to measure different forms of motivation for physical exercise and includes 5 sub-scales.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in general self-efficacy
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
The Self-Efficacy Scale is an instrument designed to measure general self-efficacy. Higher scores indicate higher self-efficacy.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in health-related quality of life
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific instrument designed to measure quality of life in patients with chronic lung disease. It has 3 domains: symptoms, activities and impact. Higher scores indicate poorer quality of life.
1 week before, 1 week after, 3 and 6 months after the PR program
Patients' perspectives about the intervention (experimental group only)
Délai: Immediately after the intervention
Semi-structured focus group interviews will be conducted with patients to explore the impact of the intervention (i.e., Pulmonary rehabilitation plus PA monitoring and feedback from a pedometer).
Immediately after the intervention

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change in lung function
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
Lung function will be assessed with spirometry, according to the American Thoracic Society/European Respiratory Society guidelines.
1 week before, 1 week after, 3 and 6 months after the PR program
Change in the number and duration of respiratory exacerbations and hospitalizations
Délai: 1 week before, 1 week after, 3 and 6 months after the PR program
The number and duration of respiratory exacerbations and hospitalizations will be assessed during patients' interview.
1 week before, 1 week after, 3 and 6 months after the PR program

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Aveiro University

Collaborateurs

Fundação para a Ciência e a Tecnologia

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 avril 2014

Achèvement primaire (Réel)

1 janvier 2015

Achèvement de l'étude (Réel)

1 janvier 2015

Dates d'inscription aux études

Première soumission

23 avril 2014

Première soumission répondant aux critères de contrôle qualité

23 avril 2014

Première publication (Estimation)

24 avril 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

15 avril 2015

Dernière mise à jour soumise répondant aux critères de contrôle qualité

14 avril 2015

Dernière vérification

1 janvier 2015

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • SFRH/BD/81328/2011

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