PICk-UP: PersonalIsed CommUnity-based Physical Activities for Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change in physical activity levels (time spent in moderate to vigorous physical activities)
研究概览
简要总结
Chronic Obstructive Pulmonary Disease (COPD) is a major individual, social and economic burden worldwide. Pulmonary rehabilitation is a fundamental evidence-based intervention to manage COPD. However, pulmonary rehabilitation benefits tend to decline over time and sustaining a long-term physical activity lifestyle is challenging, leading to worse health-related quality of life. Personalised post-pulmonary rehabilitation programmes, combining different physical activities modalities with social interaction, are warranted to enable a shift from a disease-based to a patient-centred model and encourage a sustainable behavioural change. Although such programmes have the potential to sustain pulmonary rehabilitation benefits and promote patients' long-term adherence to physical activity, their availability within the community is scarce. Hence, the investigators will implement a personalised community-based physical activity programme (PICk UP), using the available resources, adapted to patient's needs/preferences. PICk UP will be a sustainable response to support healthy lifestyles and enhance pulmonary rehabilitation benefits of respiratory patients, by integrating them within the community and embracing urban facilities.
The aim of this study is to assess the effectiveness of PICk UP, a personalised community-based physical activity programme, tailored to patients' needs and preferences, on their physical activity levels.
It is expected that PICk UP will empower patients to remain physically active and foster the maintenance of pulmonary rehabilitation benefits.
详细描述
COPD-related morbidity and mortality has been increasing, making COPD already the third leading cause of death and a growing global health concern.
Pulmonary rehabilitation (PR) is a comprehensive intervention, with known cost-effectiveness in managing patients with COPD. One of the PR goals is to improve physical activity (PA), since it has shown to reduce exacerbations and mortality.
Nevertheless, adopting/sustaining a physically active behaviour is highly challenging and benefits of PR are usually lost 6 months after its completion. Therefore, PA programmes capable to maintain the PR effects are urgently needed Community can provide different PA modalities in various settings, which can be personalised to patients' needs and preferences. By filling the gaps between healthcare systems and patients' daily environment, these programmes have the potential to improve patients' HRQoL and self-efficacy, enhancing their ability to overcome exercise barriers and their motivation to sustain a physically active behaviour.
PICk UP will offer patients different PA modalities tailored to their preferences and needs, thus personalising the community programmes, and aiming at sustaining a physically active behaviour and enhancing their HRQoL.
This study aims at assessing the effectiveness of PICk UP, a personalised community-based physical activity programme tailored to patients' needs and preferences, on their physical activity levels and on the maintenance of pulmonary rehabilitation benefits. To accomplish these aims a randomised controlled trial will be conducted.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single blind, outcome assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of a chronic obstructive pulmonary disease
- •clinically stable in the previous month (no changes in medication or occurrence of acute exacerbations)
- •≥ 18 years old
- •able to provide their own informed consent
- •patients classified as a GOLD C or D (according to the global initiative for chronic obstructive pulmonary disease criteria), or classified as GOLD B and present a FEV1%predicted<30%, or present peripheral oxygen saturation ≤90% at rest or <85 during the 6MWT must be previously assessed by pneumologist or physiatrist.
排除标准
- •Signs of cognitive impairment;
- •Neoplasic /immunologic disease or an unstable/significant cardiac, musculoskeletal, neuromuscular or psychiatric condition limiting the ability to exercise or co-operate.
结局指标
主要结局
Change in physical activity levels (time spent in moderate to vigorous physical activities)
时间窗: Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.
Accelerometer-based activity monitors. Time spent in moderate and vigorous physical activities during the day, will be collected with the activity monitors GT3X+ (ActiGraph) during one week.
次要结局
- Change in Emotional state(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Healthcare utilization (number of participants visiting emergency department)(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Adherence to the PICk UP programme(Adherence will be collected in each session of physical activity throughout the 6 months.)
- Change in steps per day(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Health-related quality of life - St. George Respiratory Questionnaire.(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in handgrip strength(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in overall functionality - physical performance test(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in experience of fatigue(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in impact and experience of fatigue(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Healthcare utilization (duration of hospital admissions)(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in exercise tolerance - 6MWT(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in quadriceps muscle strength(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in frequency of exacerbations(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Healthcare utilization (number of visits of each participant to the emergency department)(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Healthcare utilization (number of hospital admissions)(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in time spent in sedentary physical activities(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in motivation to exercise - Behavioutal regulation exercise scale(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in Physical activity(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Change in symptom's impact in patients' life(Multiple time points through study completion - immediately after pulmonary rehabilitation and up to 3 and 6 months after pulmonary rehabilitation.)
- Occurrence of adverse events(Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months.)
研究者
Alda Sofia Pires de Dias Marques
Associate Professor
Aveiro University