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

14. April 2015 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Kontrollgruppe
Verhalten: 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).
Experimental: Experimentelle Gruppe
Verhalten: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in physical activity levels
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in exercise tolerance
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in lung function
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Aveiro University

Mitarbeiter

Fundação para a Ciência e a Tecnologia

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2014

Primärer Abschluss (Tatsächlich)

1. Januar 2015

Studienabschluss (Tatsächlich)

1. Januar 2015

Studienanmeldedaten

Zuerst eingereicht

23. April 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

23. April 2014

Zuerst gepostet (Schätzen)

24. April 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

15. April 2015

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

14. April 2015

Zuletzt verifiziert

1. Januar 2015

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • SFRH/BD/81328/2011

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