Comprehensive Maintenance Program: a Health Haven for COPD in Lleida.The NAPOLEON Project.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Dyspnea (Dyspnea-12 total score)
研究概览
简要总结
Introduction:
Pulmonary rehabilitation programs (PRPs) are known to reduce symptoms such as dyspnea and fatigue, while improving functional capacity and quality of life in individuals with chronic obstructive pulmonary disease (COPD). However, the benefits of an initial pulmonary rehabilitation program (PRP) tend to diminish rapidly over time, prompting the development of strategies to maintain these effects. Such strategies include supervised exercise programs, telephone follow-ups, and home-based exercise regimens. Nevertheless, the optimal maintenance strategy remains uncertain.
Objectives:
The primary objective is to evaluate the impact of a supervised, multidimensional maintenance PRP on symptoms and quality of life in individuals with COPD. Additionally, the study aims to compare exercise capacity, healthcare resource utilization, economic benefits, and participant perceptions between the intervention and control groups.
Methodology:
A 12-month randomized controlled trial (RCT) with two parallel groups will be conducted in adults with COPD who have completed an initial 8-week PRP. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. The intervention group will undergo a maintenance PRP consisting of two weekly supervised exercise sessions and monthly educational sessions on COPD in a comprehensive health center over a 3-month period. The control group will receive standard clinical care recommendations regarding physical activity. Clinical evaluations will be conducted at four time points throughout the study: baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3). Full pulmonary function tests and anthropometric assessments will be performed at T0 and T3. Other variables, including symptom burden, quality of life, functional capacity, mental health, physical activity, sleep-wake pattern, and healthcare utilization, will be systematically collected at all four time points.
详细描述
Justification Pulmonary rehabilitation programs (PRPs) are a cost-effective therapeutic strategy to reduce dyspnea, improve exercise tolerance, and enhance health-related quality of life in individuals with chronic obstructive pulmonary disease (COPD). Conventional PRPs typically last between 6 and 8 weeks and include physical training, education, and psychosocial support. However, multiple studies have shown that the benefits gained tend to diminish within 3 to 6 months after the initial program ends, especially when structured follow-up and maintenance strategies are not implemented.
In response to this issue, various post-PRP maintenance program modalities have been proposed, such as supervised or unsupervised home-based programs, periodic telephone follow-ups, or group exercise sessions. Despite promising results from some clinical trials, the evidence remains heterogeneous and limited, both in terms of clinical efficacy and feasibility within public health systems. International clinical practice guidelines have emphasized the urgent need to evaluate sustainable and economically viable strategies to maintain the benefits of PRPs, particularly in contexts where structured continuity of care is not guaranteed.
The present study involves the implementation of a supervised maintenance post-pulmonary rehabilitation program (PRP) in an outpatient setting, adequately equipped for the intervention and coordinated by a physiotherapist affiliated with a specialized clinical setting. This intervention will consist of a three-month interdisciplinary maintenance program with biweekly supervised physical exercise sessions, education on COPD and healthy lifestyle habits, and strategies for early detection of exacerbations. It is designed as a randomized controlled trial (RCT) with a 12-month follow-up and clinical evaluations at baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3).
Specific Objectives
- To compare general and COPD-specific health-related quality of life between intervention and control groups at T0, T1, T2, and T3 using the EuroQol-5 Dimensions questionnaire (EQ-5D) and the COPD Assessment Test (CAT).
- To assess the impact of the intervention on mental health by comparing anxiety and depression levels between groups at T0, T1, T2, and T3, measured with the Hospital Anxiety and Depression Scale (HADS).
- To compare functional and exercise capacity between groups at T0, T1, T2, and T3, based on spirometry values, the six-minute walk test (6MWT), and handgrip strength.
- To compare self-reported physical activity levels using the short version of the International Physical Activity Questionnaire (IPAQ) across time points.
- To evaluate the sleep-wake pattern and determine the intervention's effect on its modulation, through analysis of sleep-wake pattern and activity variables (total sleep time, sleep latency, wake after sleep onset, light and deep sleep stages) recorded by wearable devices throughout the follow-up.
- To compare healthcare utilization at T3, including non-hospitalized exacerbations, hospital admissions, and total hospitalization days between groups.
- To assess the cost-effectiveness of the intervention from the healthcare system perspective, considering direct healthcare-related costs and the clinical benefits achieved.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding: Role separation will allow for blinding of the outcome assessor and personnel involved in data analysis and interpretation of treatment allocation.
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40 to 75 years.
- •Confirmed medical diagnosis of chronic obstructive pulmonary disease (COPD) of moderate to severe severity, based on clinical evaluation and pulmonary function testing.
- •Clinically stable for at least 4 weeks following the last severe exacerbation, as confirmed by the treating pulmonologist.
- •Referred to an outpatient pulmonary rehabilitation program due to persistent symptoms and a history of exacerbations, with moderate to severe dyspnea (Medical Research Council [MRC] dyspnea scale score > 2), according to physician assessment.
- •Completed at least 6 out of 8 sessions of a standard 8-week initial pulmonary rehabilitation program.
排除标准
- •Presence of medical contraindications to physical exercise, including unstable cardiovascular conditions (e.g., recent myocardial infarction, uncontrolled arrhythmias), severe musculoskeletal or neurological disorders, recent surgery, or acute medical conditions (e.g., recent stroke) that impair participation.
- •Severe cognitive impairment that limits the ability to understand instructions or participate actively in the program.
- •Unstable psychiatric disorders that may compromise adherence to or continuity with the exercise regimen.
- •Lack of availability or refusal to attend the scheduled sessions of the community-based exercise program.
- •Participation in another pulmonary rehabilitation program within the 6 months prior to study enrollment.
研究组 & 干预措施
Standard physical activity recommendations and unsupervised home exercise
The control group will receive general recommendations for physical activity and a table of exercises to be performed at home, as established in standard clinical practice. They will not receive supervised interventions, however, they will be followed during the 12 months of the study and evaluated at the same times and with the same variables as the intervention group (baseline (T0), 3 months (T1), 6 months (T2), and 12 months (T3)).
Supervised multidimensional pulmonary rehabilitation maintenance program
Participants assigned to the intervention group will engage in a supervised, multidimensional pulmonary rehabilitation maintenance program over a period of three months. This program will consist of two weekly sessions of supervised exercise and a total of six educational sessions, each lasting approximately 20 minutes, delivered twice per month. The educational sessions will address key topics such as the prevention and management of chronic obstructive pulmonary disease (COPD) exacerbations and the adoption of healthy lifestyle behaviors. All sessions will be conducted at a comprehensive healthcare center by a physiotherapist who serves as both the program facilitator and case manager. The aim of this intervention is to sustain the clinical benefits achieved during the initial 8-week pulmonary rehabilitation program and to promote long-term self-management and functional capacity.
干预措施: Interdisciplinary intervention (Behavioral)
结局指标
主要结局
Dyspnea (Dyspnea-12 total score)
时间窗: Month 12 post-baseline
Dyspnea will be assessed using the Dyspnea-12 (D-12) questionnaire. The D-12 is a validated self-administered tool that quantifies breathlessness across 12 descriptors (physical and affective). Each item is scored from 0 (none) to 3 (severe), yielding a total score from 0 to 36, with higher scores indicating greater severity. The primary outcome will be the D-12 total score at Month 12, compared between intervention and control groups.
次要结局
- Treatment Adherence (% attendance)(From Baseline to Month 12)
- Disease-specific Health-related Quality of Life (COPD Assessment Test, CAT total score)(Baseline, Month 3, Month 6, Month 12)
- General Health-related Quality of Life (EQ-5D-5L index and VAS score)(Baseline, Month 3, Month 6, Month 12)
- Exercise Capacity (6-minute walk test distance, meters)(Baseline, Month 3, Month 6, Month 12)
- Respiratory Function (FEV1, FVC, DLCO, % predicted)(Baseline, Month 12)
- Direct Healthcare Costs(From Baseline to Month 12)
- Quality-adjusted Life Years (QALYs)(From Baseline to Month 12)
- Cost-utility Ratio(From Baseline to Month 12)
研究者
Jessica González Gutiérrez MD, PhD
Clinical Professor
Institut de Recerca Biomèdica de Lleida