Home-monitoring and Adherence of Patients With COPD to Long-term Rehabilitation
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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
-
Aveiro、ポルトガル、3810-193
- University of Aveiro
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ:対照群
|
Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week).
|
|
実験的:実験グループ
|
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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in physical activity levels
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in exercise tolerance
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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
時間枠: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)
時間枠: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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in lung function
時間枠: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
時間枠: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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Cruz J, Brooks D, Marques A. Home telemonitoring effectiveness in COPD: a systematic review. Int J Clin Pract. 2014 Mar;68(3):369-78. doi: 10.1111/ijcp.12345. Epub 2014 Jan 28.
- Cruz J, Brooks D, Marques A. Home telemonitoring in COPD: a systematic review of methodologies and patients' adherence. Int J Med Inform. 2014 Apr;83(4):249-63. doi: 10.1016/j.ijmedinf.2014.01.008. Epub 2014 Jan 23.
- Cruz J, Brooks D, Marques A. Impact of feedback on physical activity levels of individuals with chronic obstructive pulmonary disease during pulmonary rehabilitation: A feasibility study. Chron Respir Dis. 2014 Nov;11(4):191-8. doi: 10.1177/1479972314552280. Epub 2014 Oct 2.
- Cruz J, Brooks D, Marques A. Walk2Bactive: A randomised controlled trial of a physical activity-focused behavioural intervention beyond pulmonary rehabilitation in chronic obstructive pulmonary disease. Chron Respir Dis. 2016 Feb;13(1):57-66. doi: 10.1177/1479972315619574. Epub 2015 Dec 23.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- SFRH/BD/81328/2011
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。