Physical Activity Promotion Added to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).

      Similar techniques for patients suffering mainly from depression include education about
      depression and physical inactivity and planning and recording activities each day, while
      rating these for achievement or pleasure. These techniques help to break patient inactivity,
      which can lead to low mood and poor physical condition. A key treatment for depression can
      involve encouragement to increase activities within the patients' physical capabilities. A
      study found clinical and statistically significant improvements in anxiety and depression
      scores and a statistically significant reduction in hospital admissions following CBM. CBM is
      therefore an important approach to incorporate into COPD management to improve engagement
      with both pulmonary rehabilitation and the physical activity promotion programme Heslop &
      Foley. 2009.

      The efficacy of incorporating a physical activity promotion program to standard care
      pulmonary rehabilitation along with CBM strategies is still unknown. Accordingly, it is
      proposed to study patient compliance with the physical activity promotion programme
      comprising weekly goals in terms of daily step counts measured by a commercially available
      step counter. Compliance to the intervention is defined as at least 4 days per week (> 8
      hours/day) with valid step count data (>70 steps/day) ensuring that patients use the step
      counter on a daily basis. Over the 8-week program patients should have a minimum of 6 weeks
      (75%) compliance with the physical activity intervention. If patients adhere adequately to
      this programme, a randomised controlled trial will be designed to study the long-term effects
      of adding physical activity promotion to Pulmonary Rehabilitation (including exercise
      training, education, physical activity promotion and behavioural modification strategies) on
      the risk for COPD exacerbations and hospitalisations.
    

Intervention name(s): Physical Activity Promotion
Intervention type(s): Behavioral
Intervention description(s): The physical activity (PA) promotion intervention will be provided only to the intervention group, and will include: 1) a step-counter with a digital display, 2) an interview discussing motivational issues, favourite daily activities and strategies to become more physically active; and 3) a tailored physical activity coaching plan including an Individualised activity goal (in steps/day) revised twice weekly through consultation sessions (16 sessions in total). Patients' targets will be revised twice weekly during the consultation sessions which will be incorporated into the Pulmonary rehabilitation sessions. The aim is to increase physical activity by 10% each week. The goal can be altered if required.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single centre feasibility, single blind, parallel, randomised controlled study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Pulmonary Rehabilitation; Physical activity; Anxiety and depression