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临床试验/NCT03749655
NCT03749655已完成不适用

A Feasibility Study Assessing the Inclusion of Physical Activity Promotion to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy in Patients With COPD Who Are Anxious and Depressed

Northumbria University2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Patient compliance with the physical activity promotion intervention

研究概览

简要总结

In patients with Chronic Obstructive Pulmonary Disease (COPD) daily physical activity is reduced compared to healthy age-matched individuals. Reduced levels of physical activity in patients with COPD are associated with increased risk for exacerbations, hospital admissions and mortality.

Pulmonary rehabilitation (PR) constitutes standard care for patients with COPD as it improves exercise capacity, quality of life and reduces the risk for exacerbation and hospitalisation. Participation in PR, however, does not necessarily translate into improved daily physical activity levels. It is currently uncertain whether addition of physical activity promotion strategies to standard PR programs induces an improvement in daily physical activity along with exercise capacity and quality of life compared to pulmonary rehabilitation alone.

Physical activity (PA) is a complex health behaviour that is modified by behavioural change interventions. PA promotion programs through the use of wearable monitors (i.e. pedometers, accelerometers) with goal setting and feedback, have shown to increase daily physical activity, but not exercise capacity or quality of life in COPD patients. Therefore, combination of both PR and PA promotion strategies is necessary to translate PR-induced improvements in functional capacity into improved daily physical activity level. The investigators propose to perform a feasibility study assessing patient adherence to PA promotion incorporated into a standard PR program. To enhance adherence to the PA promotion strategy, Cognitive Behavioural Modification Strategies (CBM) will be provided to patients undertaking PR. CBM strategies facilitate the goals of PR as they address several behavioural barriers including anxiety, depression and physical inactivity, and constitutes an important component in the management of COPD to improve engagement with PR and promote a physically active lifestyle. The investigators will divide patients into two programs: one including PR, PA promotion and CBM and the other comprising standard PR and CBM provision. The investigators will compare patients' adherence (16 sessions of PR) to both programs.

详细描述

Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and progressive disease, primarily affecting the respiratory system. In many patients, it also has adverse extra-pulmonary effects, such as skeletal muscle dysfunction and weakness (Maltais, et al. 2014). Pulmonary and skeletal muscle metabolic abnormalities enhance the ventilatory requirement during exercise, resulting in exercise-associated symptoms such as breathlessness and leg discomfort. These symptoms make every day physical activity an unpleasant experience, which many patients try to avoid (Troosters, et al. 2013). Physical activity levels are therefore remarkably lower in COPD patients than healthy age-matched individuals, presenting a major predictor of exacerbations, hospitalisations and mortality and in these patients (Pitta et al. 2005) & (Garcia-Aymerich et al. 2006).

Implementation of exercise training as part of Pulmonary Rehabilitation aims to reverse the systemic consequences of COPD, in particular skeletal muscle dysfunction and weakness (Troosters, et al. 2013) . Currently pulmonary rehabilitation programs have shown substantial improvements in exercise capacity; however, these findings have not consistently progressed into improvements in daily levels of physical activity (Watz et al. 2014). One reason for this may link to physical activity in COPD being a complex health behaviour (Troosters, et al. 2013).

Recently, physical activity coaching, including weekly targets and feedback, has shown to be effective in patients with COPD in terms of improving daily steps over a period of three months (Lahham et al. 2016). Accordingly, activity coaching may be added to standard pulmonary rehabilitation to facilitate the rehabilitation-induced improvements in exercise capacity to progress into improvements in physical activity (Lahham et al. 2016).

Alongside the physical barriers influencing daily physical activity, the distressing nature of COPD has a significant impact on patients' psychological well-being. Major focusing points for COPD patients are the sense of feeling unwell, the inability to perform everyday activities and the emotional consequences of the condition. These symptoms can promote anxiety and depression, which are prevalent in patients with COPD, are associated with poorer treatment outcomes, and reduced survival (Ng, T-P et al. 2007).

Cognitive Behavioural Modification (CBM) strategies constitute an intervention that focuses on understanding how experiences are interpreted. It provides an understanding of the interaction between thoughts, mood, behaviour and physical sensations, which are intrinsically linked [8]. Techniques used for anxiety include education on anxiety and COPD, planning/pacing, distraction techniques, breathing control, relaxation and managing worry. These techniques help to break the vicious cycle of anxiety and can reduce patients' distress (Heslop & Foley. 2009).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

Principle investigator will be blinded from the randomisation as this member will conduct CBT with all patients.

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

入选标准

  • COPD confirmed by obstructive spirometry
  • Clinically stable male or female COPD patients aged 40 years or older
  • Optimised medical therapy
  • Able to provide informed consent
  • HADS score of 8 and above

排除标准

  • Orthopaedic, neurological or other concomitant diseases that significantly impair normal biomechanical movement patterns, as judged by the investigator.
  • Moderate or severe COPD exacerbation (AECOPD) within 4 weeks.
  • Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.
  • Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.
  • Uncontrolled hypertension.
  • Another condition likely to limit life expectancy to less than one year (principally metastatic malignancy).

结局指标

主要结局

Patient compliance with the physical activity promotion intervention

时间窗: 8 weeks (16 sessions)

Whether patients use the step counter for an 8 week period of physical activity promotion while undertaking pulmonary rehabilitation. Compliance to the intervention is defined as at least 4 days per week with valid step count data (\>70 steps/day). Over the 8-week program patients should have a minimum of 6 weeks (75%) compliance with the physical activity intervention.

Patient Experience of Physical Activity

时间窗: Measured 1 week prior and 1 week post rehabilitation

Measured using the innovative Clinical Visit of COPD Questionnaire (C-PPAC)

次要结局

  • Change in daily physical activity.(Measured 1 week prior and 1 week post rehabilitation)
  • Change in symptoms of anxiety and depression.(Measured 1 week prior and 1 week post rehabilitation)
  • Change in functional capacity(Measured 1 week prior and 1 week post rehabilitation)
  • Change in quality of life(Measured 1 week prior and 1 week post rehabilitation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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