<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03749655</url>
  </required_header>
  <id_info>
    <org_study_id>08968</org_study_id>
    <nct_id>NCT03749655</nct_id>
  </id_info>
  <brief_title>Physical Activity Promotion Added to Standard Care Pulmonary Rehabilitation and Cognitive Behavioural Therapy</brief_title>
  <official_title>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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northumbria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Newcastle-upon-Tyne Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northumbria University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with Chronic Obstructive Pulmonary Disease (COPD) daily physical activity is&#xD;
      reduced compared to healthy age-matched individuals. Reduced levels of physical activity in&#xD;
      patients with COPD are associated with increased risk for exacerbations, hospital admissions&#xD;
      and mortality.&#xD;
&#xD;
      Pulmonary rehabilitation (PR) constitutes standard care for patients with COPD as it improves&#xD;
      exercise capacity, quality of life and reduces the risk for exacerbation and hospitalisation.&#xD;
      Participation in PR, however, does not necessarily translate into improved daily physical&#xD;
      activity levels. It is currently uncertain whether addition of physical activity promotion&#xD;
      strategies to standard PR programs induces an improvement in daily physical activity along&#xD;
      with exercise capacity and quality of life compared to pulmonary rehabilitation alone.&#xD;
&#xD;
      Physical activity (PA) is a complex health behaviour that is modified by behavioural change&#xD;
      interventions. PA promotion programs through the use of wearable monitors (i.e. pedometers,&#xD;
      accelerometers) with goal setting and feedback, have shown to increase daily physical&#xD;
      activity, but not exercise capacity or quality of life in COPD patients. Therefore,&#xD;
      combination of both PR and PA promotion strategies is necessary to translate PR-induced&#xD;
      improvements in functional capacity into improved daily physical activity level. The&#xD;
      investigators propose to perform a feasibility study assessing patient adherence to PA&#xD;
      promotion incorporated into a standard PR program. To enhance adherence to the PA promotion&#xD;
      strategy, Cognitive Behavioural Modification Strategies (CBM) will be provided to patients&#xD;
      undertaking PR. CBM strategies facilitate the goals of PR as they address several behavioural&#xD;
      barriers including anxiety, depression and physical inactivity, and constitutes an important&#xD;
      component in the management of COPD to improve engagement with PR and promote a physically&#xD;
      active lifestyle. The investigators will divide patients into two programs: one including PR,&#xD;
      PA promotion and CBM and the other comprising standard PR and CBM provision. The&#xD;
      investigators will compare patients' adherence (16 sessions of PR) to both programs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic Obstructive Pulmonary Disease (COPD) is a debilitating and progressive disease,&#xD;
      primarily affecting the respiratory system. In many patients, it also has adverse&#xD;
      extra-pulmonary effects, such as skeletal muscle dysfunction and weakness (Maltais, et al.&#xD;
      2014). Pulmonary and skeletal muscle metabolic abnormalities enhance the ventilatory&#xD;
      requirement during exercise, resulting in exercise-associated symptoms such as breathlessness&#xD;
      and leg discomfort. These symptoms make every day physical activity an unpleasant experience,&#xD;
      which many patients try to avoid (Troosters, et al. 2013). Physical activity levels are&#xD;
      therefore remarkably lower in COPD patients than healthy age-matched individuals, presenting&#xD;
      a major predictor of exacerbations, hospitalisations and mortality and in these patients&#xD;
      (Pitta et al. 2005) &amp; (Garcia-Aymerich et al. 2006).&#xD;
&#xD;
      Implementation of exercise training as part of Pulmonary Rehabilitation aims to reverse the&#xD;
      systemic consequences of COPD, in particular skeletal muscle dysfunction and weakness&#xD;
      (Troosters, et al. 2013) . Currently pulmonary rehabilitation programs have shown substantial&#xD;
      improvements in exercise capacity; however, these findings have not consistently progressed&#xD;
      into improvements in daily levels of physical activity (Watz et al. 2014). One reason for&#xD;
      this may link to physical activity in COPD being a complex health behaviour (Troosters, et&#xD;
      al. 2013).&#xD;
&#xD;
      Recently, physical activity coaching, including weekly targets and feedback, has shown to be&#xD;
      effective in patients with COPD in terms of improving daily steps over a period of three&#xD;
      months (Lahham et al. 2016). Accordingly, activity coaching may be added to standard&#xD;
      pulmonary rehabilitation to facilitate the rehabilitation-induced improvements in exercise&#xD;
      capacity to progress into improvements in physical activity (Lahham et al. 2016).&#xD;
&#xD;
      Alongside the physical barriers influencing daily physical activity, the distressing nature&#xD;
      of COPD has a significant impact on patients' psychological well-being. Major focusing points&#xD;
      for COPD patients are the sense of feeling unwell, the inability to perform everyday&#xD;
      activities and the emotional consequences of the condition. These symptoms can promote&#xD;
      anxiety and depression, which are prevalent in patients with COPD, are associated with poorer&#xD;
      treatment outcomes, and reduced survival (Ng, T-P et al. 2007).&#xD;
&#xD;
      Cognitive Behavioural Modification (CBM) strategies constitute an intervention that focuses&#xD;
      on understanding how experiences are interpreted. It provides an understanding of the&#xD;
      interaction between thoughts, mood, behaviour and physical sensations, which are&#xD;
      intrinsically linked [8]. Techniques used for anxiety include education on anxiety and COPD,&#xD;
      planning/pacing, distraction techniques, breathing control, relaxation and managing worry.&#xD;
      These techniques help to break the vicious cycle of anxiety and can reduce patients' distress&#xD;
      (Heslop &amp; Foley. 2009).&#xD;
&#xD;
      Similar techniques for patients suffering mainly from depression include education about&#xD;
      depression and physical inactivity and planning and recording activities each day, while&#xD;
      rating these for achievement or pleasure. These techniques help to break patient inactivity,&#xD;
      which can lead to low mood and poor physical condition. A key treatment for depression can&#xD;
      involve encouragement to increase activities within the patients' physical capabilities. A&#xD;
      study found clinical and statistically significant improvements in anxiety and depression&#xD;
      scores and a statistically significant reduction in hospital admissions following CBM. CBM is&#xD;
      therefore an important approach to incorporate into COPD management to improve engagement&#xD;
      with both pulmonary rehabilitation and the physical activity promotion programme Heslop &amp;&#xD;
      Foley. 2009.&#xD;
&#xD;
      The efficacy of incorporating a physical activity promotion program to standard care&#xD;
      pulmonary rehabilitation along with CBM strategies is still unknown. Accordingly, it is&#xD;
      proposed to study patient compliance with the physical activity promotion programme&#xD;
      comprising weekly goals in terms of daily step counts measured by a commercially available&#xD;
      step counter. Compliance to the intervention is defined as at least 4 days per week (&gt; 8&#xD;
      hours/day) with valid step count data (&gt;70 steps/day) ensuring that patients use the step&#xD;
      counter on a daily basis. Over the 8-week program patients should have a minimum of 6 weeks&#xD;
      (75%) compliance with the physical activity intervention. If patients adhere adequately to&#xD;
      this programme, a randomised controlled trial will be designed to study the long-term effects&#xD;
      of adding physical activity promotion to Pulmonary Rehabilitation (including exercise&#xD;
      training, education, physical activity promotion and behavioural modification strategies) on&#xD;
      the risk for COPD exacerbations and hospitalisations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 20, 2018</start_date>
  <completion_date type="Actual">August 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Single centre feasibility, single blind, parallel, randomised controlled study.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Principle investigator will be blinded from the randomisation as this member will conduct CBT with all patients.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient compliance with the physical activity promotion intervention</measure>
    <time_frame>8 weeks (16 sessions)</time_frame>
    <description>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 (&gt;70 steps/day). Over the 8-week program patients should have a minimum of 6 weeks (75%) compliance with the physical activity intervention.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Experience of Physical Activity</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Measured using the innovative Clinical Visit of COPD Questionnaire (C-PPAC)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in daily physical activity.</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Measured via steps/day using a triaxial accelerometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptoms of anxiety and depression.</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scale measures for Anxiety and Depression are both out of 21. Scoring is grouped as: Normal= 0-7, Borderline abnormal= 8-10, 11-21= Abnormal.&#xD;
For the investigators study a score for Anxiety and/or depression of &gt;8 is required at inclusion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional capacity</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Assessed by the 6-min walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Assessed using COPD Assessment Test (COPD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life</measure>
    <time_frame>Measured 1 week prior and 1 week post rehabilitation</time_frame>
    <description>Assessed using the clinical COPD questionnaire (CCQ). The total CCQ score is calculated by adding the scores of the ten items and dividing that number by 10. The scale varies between 0 (very good health) to 6 (extremely poor health status).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>PR+CBT</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PR+CBT+PA Promotion.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy and physical activity promotion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Physical Activity Promotion</intervention_name>
    <description>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.</description>
    <arm_group_label>PR+CBT+PA Promotion.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD confirmed by obstructive spirometry&#xD;
&#xD;
          -  Clinically stable male or female COPD patients aged 40 years or older&#xD;
&#xD;
          -  Optimised medical therapy&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  HADS score of 8 and above&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Orthopaedic, neurological or other concomitant diseases that significantly impair&#xD;
             normal biomechanical movement patterns, as judged by the investigator.&#xD;
&#xD;
          -  Moderate or severe COPD exacerbation (AECOPD) within 4 weeks.&#xD;
&#xD;
          -  Unstable ischaemic heart disease, including myocardial infarction within 6 weeks.&#xD;
&#xD;
          -  Moderate or severe aortic stenosis or hypertrophic obstructive cardiomyopathy.&#xD;
&#xD;
          -  Uncontrolled hypertension.&#xD;
&#xD;
          -  Another condition likely to limit life expectancy to less than one year (principally&#xD;
             metastatic malignancy).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Newcastle upon Tyne NHS trust</name>
      <address>
        <city>Newcastle Upon Tyne</city>
        <state>Tyne And Wear</state>
        <zip>NE18ST</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Maltais F, Decramer M, Casaburi R, Barreiro E, Burelle Y, Debigare R, Dekhuijzen PN, Franssen F, Gayan-Ramirez G, Gea J, Gosker HR, Gosselink R, Hayot M, Hussain SN, Janssens W, Polkey MI, Roca J, Saey D, Schols AM, Spruit MA, Steiner M, Taivassalo T, Troosters T, Vogiatzis I, Wagner PD; ATS/ERS Ad Hoc Committee on Limb Muscle Dysfunction in COPD. An official American Thoracic Society/European Respiratory Society statement: update on limb muscle dysfunction in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2014 May 1;189(9):e15-62. doi: 10.1164/rccm.201402-0373ST.</citation>
    <PMID>24787074</PMID>
  </reference>
  <reference>
    <citation>Troosters T, van der Molen T, Polkey M, Rabinovich RA, Vogiatzis I, Weisman I, Kulich K. Improving physical activity in COPD: towards a new paradigm. Respir Res. 2013 Oct 30;14(1):115. doi: 10.1186/1465-9921-14-115.</citation>
    <PMID>24229341</PMID>
  </reference>
  <reference>
    <citation>Pitta F, Troosters T, Spruit MA, Probst VS, Decramer M, Gosselink R. Characteristics of physical activities in daily life in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2005 May 1;171(9):972-7. doi: 10.1164/rccm.200407-855OC. Epub 2005 Jan 21.</citation>
    <PMID>15665324</PMID>
  </reference>
  <reference>
    <citation>Garcia-Aymerich J, Lange P, Benet M, Schnohr P, Anto JM. Regular physical activity reduces hospital admission and mortality in chronic obstructive pulmonary disease: a population based cohort study. Thorax. 2006 Sep;61(9):772-8. doi: 10.1136/thx.2006.060145. Epub 2006 May 31.</citation>
    <PMID>16738033</PMID>
  </reference>
  <reference>
    <citation>Watz H, Pitta F, Rochester CL, Garcia-Aymerich J, ZuWallack R, Troosters T, Vaes AW, Puhan MA, Jehn M, Polkey MI, Vogiatzis I, Clini EM, Toth M, Gimeno-Santos E, Waschki B, Esteban C, Hayot M, Casaburi R, Porszasz J, McAuley E, Singh SJ, Langer D, Wouters EF, Magnussen H, Spruit MA. An official European Respiratory Society statement on physical activity in COPD. Eur Respir J. 2014 Dec;44(6):1521-37. doi: 10.1183/09031936.00046814. Epub 2014 Oct 30.</citation>
    <PMID>25359358</PMID>
  </reference>
  <reference>
    <citation>Lahham A, McDonald CF, Holland AE. Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials. Int J Chron Obstruct Pulmon Dis. 2016 Dec 8;11:3121-3136. doi: 10.2147/COPD.S121263. eCollection 2016.</citation>
    <PMID>27994451</PMID>
  </reference>
  <reference>
    <citation>Ng TP, Niti M, Tan WC, Cao Z, Ong KC, Eng P. Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life. Arch Intern Med. 2007 Jan 8;167(1):60-7. doi: 10.1001/archinte.167.1.60.</citation>
    <PMID>17210879</PMID>
  </reference>
  <reference>
    <citation>Heslop K, Foley T. Using cognitive behavioural therapy to address the psychological needs of patients with COPD. Nurs Times. 2009 Sep 29-Oct 5;105(38):18-9.</citation>
    <PMID>19860064</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <last_update_submitted>April 4, 2022</last_update_submitted>
  <last_update_submitted_qc>April 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Rehabilitation</keyword>
  <keyword>Physical activity</keyword>
  <keyword>Anxiety and depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 24, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT03749655/Prot_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03749655
org study id: 08968
nct id: NCT03749655
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Single centre feasibility, single blind, parallel, randomised controlled study.
primary purpose: Other
masking: None (Open Label)
masking description: Principle investigator will be blinded from the randomisation as this member will conduct CBT with all patients.
measure: Patient compliance with the physical activity promotion intervention
time frame: 8 weeks (16 sessions)
description: 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.
measure: Patient Experience of Physical Activity
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Measured using the innovative Clinical Visit of COPD Questionnaire (C-PPAC)
measure: Change in daily physical activity.
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Measured via steps/day using a triaxial accelerometer
measure: Change in symptoms of anxiety and depression.
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire. Scale measures for Anxiety and Depression are both out of 21. Scoring is grouped as: Normal= 0-7, Borderline abnormal= 8-10, 11-21= Abnormal.
For the investigators study a score for Anxiety and/or depression of >8 is required at inclusion.
measure: Change in functional capacity
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Assessed by the 6-min walk test
measure: Change in quality of life
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Assessed using COPD Assessment Test (COPD)
measure: Change in quality of life
time frame: Measured 1 week prior and 1 week post rehabilitation
description: Assessed using the clinical COPD questionnaire (CCQ). The total CCQ score is calculated by adding the scores of the ten items and dividing that number by 10. The scale varies between 0 (very good health) to 6 (extremely poor health status).
arm group label: PR+CBT
arm group type: No Intervention
description: Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy
arm group label: PR+CBT+PA Promotion.
arm group type: Experimental
description: Standard care Pulmonary rehabilitation will be given alongside cognitive behavioural therapy and physical activity promotion.
intervention type: Behavioral
intervention name: Physical Activity Promotion
description: 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.
arm group label: PR+CBT+PA Promotion.
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: United Kingdom
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PMID: 24787074
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PMID: 24229341
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PMID: 15665324
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PMID: 16738033
citation: Watz H, Pitta F, Rochester CL, Garcia-Aymerich J, ZuWallack R, Troosters T, Vaes AW, Puhan MA, Jehn M, Polkey MI, Vogiatzis I, Clini EM, Toth M, Gimeno-Santos E, Waschki B, Esteban C, Hayot M, Casaburi R, Porszasz J, McAuley E, Singh SJ, Langer D, Wouters EF, Magnussen H, Spruit MA. An official European Respiratory Society statement on physical activity in COPD. Eur Respir J. 2014 Dec;44(6):1521-37. doi: 10.1183/09031936.00046814. Epub 2014 Oct 30.
PMID: 25359358
citation: Lahham A, McDonald CF, Holland AE. Exercise training alone or with the addition of activity counseling improves physical activity levels in COPD: a systematic review and meta-analysis of randomized controlled trials. Int J Chron Obstruct Pulmon Dis. 2016 Dec 8;11:3121-3136. doi: 10.2147/COPD.S121263. eCollection 2016.
PMID: 27994451
citation: Ng TP, Niti M, Tan WC, Cao Z, Ong KC, Eng P. Depressive symptoms and chronic obstructive pulmonary disease: effect on mortality, hospital readmission, symptom burden, functional status, and quality of life. Arch Intern Med. 2007 Jan 8;167(1):60-7. doi: 10.1001/archinte.167.1.60.
PMID: 17210879
citation: Heslop K, Foley T. Using cognitive behavioural therapy to address the psychological needs of patients with COPD. Nurs Times. 2009 Sep 29-Oct 5;105(38):18-9.
PMID: 19860064
responsible party type: Sponsor
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
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