CENTR(AR): Lungs Moving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in PA levels (time spent in moderate to vigorous physical activity (MVPA))
研究概览
简要总结
Chronic Respiratory Diseases (CRDs) are associated with substantial morbidity and mortality, ranking as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a fundamental evidence-based intervention for the management of a variety of CRDs, such as Chronic Obstructive Pulmonary Disease (COPD) and Interstitial Lung Diseases (ILDs). However, the benefits of PR tend to decline over time and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. There is an urgent need for evidence-based interventions to promote physical activity (PA) participation, whilst maintaining PR positive effects in the long-term. Community-based PA interventions adjusted to the local context, as well as patients' needs and preferences, might be a key strategy to meet this target. CENTR(AR) will be a sustainable response to support healthy lifestyles and enhance long-term PR benefits, by providing access to PR within Primary Healthcare Centres (PHC), followed by the inclusion in a community-based PA program, which embraces urban facilities and available resources.
详细描述
The Global Burden Disease Study 2017 estimated that 544.9 million people worldwide had a chronic respiratory disease (CRD). Globally, it is estimated that 3.914.196 deaths were due to CRDs in 2017, accounting for 7% of total all-cause deaths, ranking CRDs as the third leading cause of death worldwide. Pulmonary rehabilitation (PR) is a well-established, cost-effective intervention for the management of CRDs (e.g., COPD, ILD), which has been found to improve exercise capacity, dyspnoea and quality of life. Unfortunately, PR remains an underutilized resource in the community. Despite substantial improvement following PR, benefits tend to decline over time (approximately, within a 12-month period) and there is currently no strong evidence that patients translate those benefits into a more active lifestyle. This is of utmost importance since physical activity (PA) levels predict important outcomes in COPD, for example, with low PA levels being associated with a higher risk of exacerbation-related hospitalization and mortality. That said, it is still unknown how best to maintain long-term effects of PR, whilst promoting patients' adherence to a physically active lifestyle. Most studies reporting on interventions to improve PA among patients with CRDs (e.g., COPD) focus exclusively on patients' individual factors, disregarding interpersonal/social and environmental factors associated with PA. Community-based PA interventions adjusted to the local context, which leverage existing social support and community (infra)structures, may be key elements for success. Indeed, the community offers a variety of physical activity modalities (e.g., urban trails, physical activity/exercise classes at the municipality level), which can be explored and further personalized to meet patients' needs and preferences. By targeting the community, as opposed to the "individual per se", the possibility of promoting a behavioral change towards a more physically active lifestyle becomes more likely. Building on existing knowledge, CENTR(AR) primary aim is to implement and assess the effectiveness of a personalised community-based PA program to increase PA levels, as well as prevent/stop the decline and consolidate PR benefits (in several health-related domains) in people with CRDs, following PR.
Additionally, CENTR(AR) will also aim at:
- Improving access to and delivery of community-based PR for people with CRDs in Primary Healthcare Centres (PHC) within the Centre Region of Portugal; 2) Identifying barriers and facilitators, as well as preferences and motivations of adherence to PA; 3) Educating/Empowering/Capacitating non-health professionals delivering municipal physical activity/exercise classes, to ensure patients' safety and quality care; 4) Designing and validating urban walking and/or cycling trails by a) measuring the physiological response and energy expenditure associated with the use of those trails; b) assessing the environmental/physical features of the urban trails; 5) Validating the available municipal physical activity/exercise classes (as described in 3); 6) Promoting intersectoral collaboration at the municipality level, leveraging partnerships between PHC and existing community physical activities, thereby filling in the gaps in the continuity of care after PR; 7) Increasing health literacy amongst municipal professionals in regard to CRDs, as well as health promotion and community empowerment.
Randomized Controlled Trial (RCT)
Aims & Outcomes Primary aim: Assess the effectiveness of a community-based PA program, tailored to patient's needs and preferences, to increase PA levels in people with CRDs.
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)
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 respiratory disease;
- •Stable clinical condition (defined as no acute exacerbation or hospitalization in the previous month).
排除标准
- •Signs of cognitive impairment;
- •Neoplasic/Immunologic disease or an unstable/significant cardiac (e.g., exertional angina, valvular heart disease, congestive heart failure, etc.), musculoskeletal/orthopaedic, neuromuscular or psychiatric condition limiting ability to exercise or co-operate.
结局指标
主要结局
Change in PA levels (time spent in moderate to vigorous physical activity (MVPA))
时间窗: before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.
Time spent in MVPA will be collected with the ActiGraph accelerometry-based activity monitors (wGT3X-BT) during for week. Raw data will be downloaded, summed and filtered by the ActiLife software (Version 6.13.4) to determine the average MVPA (min/wk).
次要结局
- Change in health-related quality of life (HRQoL) - St. George Respiratory Questionnaire(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in step count (steps/day-1)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in quadriceps muscle strength - Isometric dynamometry(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in PA levels (time spent in sedentary behaviour)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Healthcare utilisation - AECOPD frequency (previous year)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in handgrip strength - Isometric dynamometry(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Healthcare utilisation - Emergency department visits (number of visits per participant)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in healthcare utilization - Hospital (re)admissions (number of hospital admissions per participant)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in healthcare utilization - Hospital (re)admissions (length of stay per hospital admission)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in PA levels - Brief Physical Activity Questionnaire(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in impact of symptoms - COPD Assessment Test (CAT)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in exercise capacity/tolerance - 6-minute walk test (6MWT)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in overall functional status/physical function - Physical Performance Test(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in exercise tolerance/capacity and (lower limb) functional capacity - 1-minute sit-to-stand test(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in motivation to exercise - The Behavioural Regulation Exercise Scale-2 (BREQ-2)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in emotional status - Hospital Anxiety and Depression Scale (HADS)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in subjective experience of fatigue - Checklist of Individual Strength - Fatigue subscale(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in impact of cough and sputum - Cough and Sputum Assessment Questionnaire (CASA-Q)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Change in peripheral muscle strength (one- (1RM) or ten- (10RM) repetition maximum)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Occurrence of adverse events(Occurrence of an adverse event will be collected in each session of physical activity throughout the 6 months)
- Change in impact of fatigue - Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Adherence to the physical activity programme(Adherence will be collected in each session of physical activity throughout the 6 months.)
- Change in perceived social support - six-item Social Support Questionnaire (SSQ6)(before PR (T0), immediately after PR (T1), and after a 3, 6 and 12 month-period.)
- Quality trail experience(Immediately after PR)
研究者
Alda Sofia Pires de Dias Marques
Associate Professor
Aveiro University