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

14 kwietnia 2015 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

32

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Grupa kontrolna
Behawioralne: 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).
Eksperymentalny: Grupa eksperymentalna
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in physical activity levels
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in exercise tolerance
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change in lung function
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Aveiro University

Współpracownicy

Fundação para a Ciência e a Tecnologia

Publikacje i pomocne linki

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 kwietnia 2014

Zakończenie podstawowe (Rzeczywisty)

1 stycznia 2015

Ukończenie studiów (Rzeczywisty)

1 stycznia 2015

Daty rejestracji na studia

Pierwszy przesłany

23 kwietnia 2014

Pierwszy przesłany, który spełnia kryteria kontroli jakości

23 kwietnia 2014

Pierwszy wysłany (Oszacować)

24 kwietnia 2014

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

15 kwietnia 2015

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

14 kwietnia 2015

Ostatnia weryfikacja

1 stycznia 2015

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • SFRH/BD/81328/2011

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