<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/NCT03264924</url>
  </required_header>
  <id_info>
    <org_study_id>LiverpoolHeartNHS</org_study_id>
    <nct_id>NCT03264924</nct_id>
  </id_info>
  <brief_title>Improving Physical Activity in Rehabilitation</brief_title>
  <acronym>IPAiR</acronym>
  <official_title>A Single-Centre, Feasibility Study to Promote Physical Activity Uptake and Adherence in Cardiac and Pulmonary Rehabilitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Liverpool Heart and Chest Hospital NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Edge Hill University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Liverpool Heart and Chest Hospital NHS Foundation Trust</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>
      Cardiac rehabilitation is a programme of exercise and health advice for people recovering&#xD;
      from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic&#xD;
      lung disease. For both groups of patients, taking part in rehabilitation can lead to&#xD;
      improvements in health and well-being. However, only 30% of patients complete their agreed&#xD;
      rehabilitation programme. This costs the NHS millions of pounds every year. This project aims&#xD;
      to investigate whether a motivational-based intervention, underpinned by self-determination&#xD;
      theory and motivational interviewing, will enable staff to encourage more patients to take&#xD;
      part in physical activity (PA). Staff will be trained with the new communication skills and&#xD;
      will then deliver the rehabilitation programme. The session content will not change, just the&#xD;
      way in which staff speak to patients.&#xD;
&#xD;
      This will be a two-phase study. Phase A will take a qualitative approach collect patient and&#xD;
      staff feedback about the current rehabilitation programme, before using this information to&#xD;
      develop and pilot the intervention. Phase B will then assess the feasibility of the&#xD;
      intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part&#xD;
      in the phase B will be required to complete an interview and questionnaire at three time&#xD;
      points. Patients' personal opinions of the programmes will be extremely important in&#xD;
      discovering what can be done to improve rehabilitation for future participants.&#xD;
&#xD;
      The main objectives will be to look at whether the intervention increases the number of&#xD;
      patients taking part in physical activity. The investigators plan to establish how much&#xD;
      physical activity patients take part in whilst they are in rehabilitation, as well as once&#xD;
      they have left the programme. This is why participants will be interviewed three and six&#xD;
      months after they have finished their rehabilitation programme.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background and Rationale&#xD;
&#xD;
      Description of research questions and justification for undertaking the trial Cardiac&#xD;
      Rehabilitation (CR) is an effective treatment for CHD and CVD patients, boasting a range of&#xD;
      physiological and psychological benefits as well as lowering mortality and risk of secondary&#xD;
      cardiac incidents. Despite the aforementioned benefits of CR attendance, uptake and adherence&#xD;
      to CR remain inadequate, with cross-cultural surveys demonstrating that only 10-30% of&#xD;
      eligible CR patients engage in such programmes. These poor levels of CR participation have&#xD;
      been previously attributed to low referral rates amongst healthcare providers, however even&#xD;
      within the 30% of eligible patients who become CR participants, the attrition rate is&#xD;
      currently 50% and only 20% of attendees report long-term behavioural change. The lack of&#xD;
      subsequent engagement with the desired adaptive behaviours is at a great cost to the National&#xD;
      Health Service (NHS), with the cost of delivering a &quot;good quality CR service&quot; at £477 per&#xD;
      patient and the average cardiac readmission costing £3637. Although physical activity (PA)&#xD;
      has been demonstrated to reduce the risk of secondary cardiac incidents, 80% of CR patients&#xD;
      fail to maintain regular habitual PA within the first year following a course of CR..&#xD;
&#xD;
      Similarly, Pulmonary Rehabilitation (PR) has been demonstrated to be an effective&#xD;
      non-pharmacological intervention for COPD patients, and aims to return the patient to&#xD;
      independent functioning, reduce disability and improve quality of life. The clinical&#xD;
      conditions for which PR is routinely offered result in progressive loss of function over&#xD;
      time. Therefore, any initial beneficial effects of a PR programme are likely to diminish over&#xD;
      the subsequent eighteen months. Within this time period however, patients who complete PR&#xD;
      have significantly greater quality of life, PA capacity, and fewer days in hospital relative&#xD;
      to participants who do not participate in PR . Despite these benefits, uptake and adherence&#xD;
      to PR is extremely problematic, with studies demonstrating that less than 50% of patients&#xD;
      referred to PR will complete the course. Additionally, adherence rates reported in randomised&#xD;
      controlled trials tend to be higher, so even this bleak estimate of adherence may be&#xD;
      inflated.&#xD;
&#xD;
      Background Information&#xD;
&#xD;
      A commonality between CR and PR is the patients' participation in physical activity. Regular&#xD;
      participation in physical activity (PA) reduces all-cause mortality by 30%, and can help to&#xD;
      manage over 20 chronic conditions, including CHD, stroke, type 2 diabetes, cancer, obesity,&#xD;
      mental health problems and musculoskeletal conditions. COPD patients' engagement in&#xD;
      low-to-moderate intensity daily PA has been shown to enhance their cardiorespiratory health&#xD;
      and ability for exertion, and reduce dyspnoea symptoms . Additionally, PA reduces cardiac&#xD;
      mortality by 31%, and has been demonstrated to lower blood pressure, and increase 'good'&#xD;
      cholesterol in cardiac patients. These effects occur through engagement in relatively low&#xD;
      levels of activity: 30 minutes, five times per week.&#xD;
&#xD;
      Despite these far-reaching benefits, patients are less likely than non-symptomatic&#xD;
      individuals to engage with PA. In 2015, a report by the Academy of Medical Royal Colleges&#xD;
      portrayed PA as a 'miracle cure', which despite having a better disease risk reduction than&#xD;
      many drugs, is often overlooked by healthcare providers and their patients. Worryingly, with&#xD;
      the number of older people with multiple medical problems increasing rapidly, less than a&#xD;
      third of UK adults over the age of 65 meet the minimum levels of PA.&#xD;
&#xD;
      Theoretical Underpinning&#xD;
&#xD;
      Motivation is a key component of behaviour change. With the focus on the motivational aspects&#xD;
      of behaviour change in mind, Self-Determination Theory (SDT) has become an increasingly&#xD;
      commonly used theory to design health behaviour change interventions . According to SDT&#xD;
      individuals adopt or change behaviour on the basis of internal satisfaction and fulfilment,&#xD;
      termed as intrinsic motivation. Alternatively, individuals are less likely to adopt or change&#xD;
      behaviour when a reward or inducement provided by an external person is used to compel a&#xD;
      person to act, known as extrinsic motivation. Environments that support intrinsic motivation&#xD;
      optimise behavioural effort, persistence and performance. In contrast, environments that&#xD;
      coerce through rewards serve to diminish behavioural effort, persistence and performance .&#xD;
&#xD;
      Previous SDT research has demonstrated that intrinsic motivation towards treatment is&#xD;
      positively associated with adherence to medical regimes among people with chronic illnesses,&#xD;
      attendance/involvement in an addiction treatment program, and long-term maintenance of weight&#xD;
      loss among morbidly obese patients. Within physical activity research, intrinsic motivation&#xD;
      has been found to be strongly associated with physical activity engagement. Similarly,&#xD;
      increases in intrinsic motivation from pre- to post- exercise referral scheme significantly&#xD;
      predicted greater adherence to the scheme as well as greater sports-related physical&#xD;
      activity. The dense body of SDT research in health, including physical activity, suggests&#xD;
      that interventions underpinned by SDT, should develop and support intrinsic motivation in&#xD;
      order to optimally motivate engagement with PA.&#xD;
&#xD;
      Motivational interviewing (MI) is a method of strengthening personal motivation for change,&#xD;
      and has been shown to be a promising approach for promoting health behaviour change in a&#xD;
      number of contexts including physical activity promotion. MI comprises several techniques&#xD;
      used by practitioners to facilitate behaviour change in patients. Some techniques focus on&#xD;
      the content of the intervention, whereas others focus on techniques reflect the&#xD;
      practitioner's interpersonal style of delivery. One of the primary roles the MI approach is&#xD;
      to evoke the patient's arguments for change and to reduce their own arguments for not&#xD;
      changing.&#xD;
&#xD;
      Research Critique&#xD;
&#xD;
      Motivational theories that inform behaviour change (for example, SDT) do not typically feed&#xD;
      through to into instructor training programmes, particularly in clinical rehabilitation&#xD;
      settings. Therefore, a significant limitation of motivational theory to date is its ability&#xD;
      to be translated into clinical practice. Accordingly, it is important that attempts are made&#xD;
      to ensure motivational theory is translated effectively in clinical practice in order to&#xD;
      increase patients' motivation for physical activity uptake and adherence in cardiac and&#xD;
      pulmonary rehabilitation. The current research, therefore, will combine a well-established&#xD;
      motivational theory (i.e., Self-Determination Theory) with established motivational practice&#xD;
      (i.e., Motivational Interviewing) in an attempt to integrate theory and practice, offsetting&#xD;
      Ntoumanis et al's. claims that contemporary motivation research does not typically feed&#xD;
      through to instructor programmes.&#xD;
&#xD;
      Previous researches aiming to increase physical activity motivation in rehabilitation have&#xD;
      predominantly focused on interventions at an individual-level. Whilst it is important not to&#xD;
      completely disregard this approach, the NHS rehabilitation setting is typically a place where&#xD;
      clinicians have to facilitate sessions on a group-level. Furthermore, the NHS may not have&#xD;
      the resources to provide the sufficient level of treatment fidelity that one-to-one&#xD;
      approaches require in order to be successful. Therefore, the current research will equip&#xD;
      clinicians with skills to be effective for increasing group-level physical activity&#xD;
      motivation, as well as on an individual level.&#xD;
&#xD;
      Motivational-based intervention research for changing increasing physical activity behaviour&#xD;
      in clinical rehabilitation settings has predominantly focused on intervention effectiveness&#xD;
      for changing behavioural outcomes. However, the intervention development, delivery and&#xD;
      content are not often reported, therefore, limiting the applied utility and replication of&#xD;
      the intervention itself. As such, the current research will pilot and feasibly investigate&#xD;
      the development of a motivational-based intervention. Doing so will provide a more nuanced&#xD;
      understanding for motivating cardiac and pulmonary patients' uptake and adherence to physical&#xD;
      rehabilitation activity. Such information would also be crucial for informing a future RCT&#xD;
      trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">January 30, 2020</completion_date>
  <primary_completion_date type="Actual">January 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage enrolment and attendance to rehabilitation</measure>
    <time_frame>June 2018-February 2019.</time_frame>
    <description>Measure of percentage enrolment and attendance to rehabilitation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative Impact Evaluation</measure>
    <time_frame>June 2018-February 2019. Interviews will be conducted upon discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge</time_frame>
    <description>Semi-Structured interview with patients and staff.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment Self Regulation Questionnaire (Exercise)</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>The treatment self-regulation questionnaire (TSRQ) assessed autonomous and controlled reasons for participation in the program. The TSRQ has 18 item stems such as: &quot;I am staying in the program because…&quot;, followed by several reasons that vary in the extent to which they represent autonomous regulation. An example of more controlled reasons are:&quot;I feel like a failure if I don't&quot;. An example of more autonomous reasons are &quot;I believe it's the best way to help myself.&quot; Each reason was rated on a 7-point scale ranging from not true at all to very true. Typically, the responses on the autonomous items are summed to form the autonomous regulation score (range 5-35) for the target behavior while responses on the controlled items are summed to form the controlled regulation score (range 8-56). These two subscale scores are used separately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Physical Activity Questionnaire Short Version (IPAQ)</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>The IPAQ measures the level of PA across four domains; leisure time PA, domestic and gardening (yard) activities, work- related PA, and transport- related PA. In each domain, the duration (in minutes) and frequency (days) of PA including sitting, walking, moderate and vigorous PA are self-reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol, five dimensions, three levels (EQ-5D-3L)</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>Health related quality of life will be measured using the EuroQol, five dimensions, three levels (EQ-5D-3L). The EQ-5D-3L determines self-assessed problems across five items of mobility, self-care, usual activities, pain/dis- comfort and anxiety/depression. Each item has three levels of severity: 'no problems', 'some problems' and 'severe problems'.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Competence Scale (Exercising Regularly)</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>The Perceived Competence Scale (PCS) assesses the degree to which patients feel confident about being able to make and maintain their participation in the rehabilitation programme and PA.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Environmental Supportiveness Scale (PESS)</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>Markland and Tobin (2010) developed the Perceived Environmental Supportiveness Scale (PESS) to assess perceptions of need support provided by exercise practicioners to exercise referral scheme clients. The PESS was designed to explicitly assess the three dimensions of support (autonomy support, structure and involvement) and comprises 15 items with five items assessing each of the three dimensions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relatedness to Others in Physical Activity (ROPAS) Scale</measure>
    <time_frame>June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.</time_frame>
    <description>The Relatedness to Others in Physical Activity Scale (ROPAS) (Wilson &amp; Bengoechea, 2010) will be used to assess participants' perceptions of the group climate. Participants responded to 6-items assessing respondents' perception of meaningful connection and belongingness to other group members. Items are rated on a 6-pt likert scale and a priori criteria for summary scores are set at ≥4.5. An example item includes, &quot;I have developed a close bond with others.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Test of Exercise Capacity</measure>
    <time_frame>Test will be completed upon admission to rehabilitation, and at discharge (on average 8 weeks following admission to rehabilitation).</time_frame>
    <description>Patients will complete either an Incremental Shuttle Walking Test (ISWT), six-minute walk test (6MWT), or bike test. In all cases, patients' perceived exertion will be assessed with the 15-point single-item Rating of Perceived Exertion (RPE; Borg, 1998), which ranges from 6 (no exertion at all) to 20 (maximal exertion).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attendance at Rehabilitation Sessions</measure>
    <time_frame>Throughout rehabilitation programme (on average 8 weeks).</time_frame>
    <description>The number of sessions, over an average of 8 weeks, that each participant attends will be recorded.</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">82</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <condition>Pulmonary Disease</condition>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Phase A, Study One</arm_group_label>
    <description>Semi-structured interviews to investigate staff and patients' experiences of participating and facilitating cardiac and pulmonary rehabilitation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase A, Study Two</arm_group_label>
    <description>Focus group with rehabilitation stakeholders to discuss perceived feasibility and acceptability of the intervention design.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase A, Study Three</arm_group_label>
    <description>Pilot of the intervention, using a group of exercise physiologists external to the community rehabilitation services.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Phase B</arm_group_label>
    <description>Community rehabilitation service staff will participate in the intervention. Patients will then participate in the rehabilitaiton programme. Physical activity levels of patients will be recorded throughout the rehabilitation programme and for six months post-discharge. Qualitative and quantitative follow-up sessions will patients will take place at discharge (8 weeks after start of rehabilitation), and three and six months post-discharge.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>IPAIR</intervention_name>
    <description>Motivational interview training</description>
    <arm_group_label>Phase A, Study Three</arm_group_label>
    <arm_group_label>Phase B</arm_group_label>
    <other_name>Motivational interview training</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cardiac and pulmonary rehabilitation patients and staff.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        1. Inclusion criteria - Patients will be included when they enrol into cardiac and&#xD;
             pulmonary rehabilitation programme due to heart disease or chronic obstructive&#xD;
             pulmonary disease.&#xD;
&#xD;
          2. Exclusion criteria - They will be excluded if they have previously completed a&#xD;
             cardiac/pulmonary rehabilitation programme.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Adrian W Midgley, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool Heart and Chest Hospital NHS Foundation Trust/ Edge Hill University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bashir Matata, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Liverpool Heart and Chest Hospital NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Liverpool Heart and Chest Hospital NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <state>Merseyside</state>
        <zip>L14 3PE</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
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  <reference>
    <citation>The Academy of Medical Royal Colleges. (2015). Exercise: The miracle cure and the role of the doctor in promoting it. Report from the Academy of Medical Royal Colleges. London. Retrieved from http://www.aomrc.org.uk</citation>
  </reference>
  <reference>
    <citation>Yohannes AM, Doherty P, Bundy C, Yalfani A. The long-term benefits of cardiac rehabilitation on depression, anxiety, physical activity and quality of life. J Clin Nurs. 2010 Oct;19(19-20):2806-13. doi: 10.1111/j.1365-2702.2010.03313.x. Epub 2010 Aug 24.</citation>
    <PMID>20738450</PMID>
  </reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>June 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>motivation</keyword>
  <keyword>behaviour change</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to share IPD</ipd_description>
  </patient_data>
  <!-- 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/NCT03264924
org study id: LiverpoolHeartNHS
nct id: NCT03264924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cardiac rehabilitation is a programme of exercise and health advice for people recovering
      from heart disease. Pulmonary rehabilitation is a similar programme for people with chronic
      lung disease. For both groups of patients, taking part in rehabilitation can lead to
      improvements in health and well-being. However, only 30% of patients complete their agreed
      rehabilitation programme. This costs the NHS millions of pounds every year. This project aims
      to investigate whether a motivational-based intervention, underpinned by self-determination
      theory and motivational interviewing, will enable staff to encourage more patients to take
      part in physical activity (PA). Staff will be trained with the new communication skills and
      will then deliver the rehabilitation programme. The session content will not change, just the
      way in which staff speak to patients.

      This will be a two-phase study. Phase A will take a qualitative approach collect patient and
      staff feedback about the current rehabilitation programme, before using this information to
      develop and pilot the intervention. Phase B will then assess the feasibility of the
      intervention within cardiac and pulmonary rehabilitation. Participants agreeing to take part
      in the phase B will be required to complete an interview and questionnaire at three time
      points. Patients' personal opinions of the programmes will be extremely important in
      discovering what can be done to improve rehabilitation for future participants.

      The main objectives will be to look at whether the intervention increases the number of
      patients taking part in physical activity. The investigators plan to establish how much
      physical activity patients take part in whilst they are in rehabilitation, as well as once
      they have left the programme. This is why participants will be interviewed three and six
      months after they have finished their rehabilitation programme.
Background and Rationale

      Description of research questions and justification for undertaking the trial Cardiac
      Rehabilitation (CR) is an effective treatment for CHD and CVD patients, boasting a range of
      physiological and psychological benefits as well as lowering mortality and risk of secondary
      cardiac incidents. Despite the aforementioned benefits of CR attendance, uptake and adherence
      to CR remain inadequate, with cross-cultural surveys demonstrating that only 10-30% of
      eligible CR patients engage in such programmes. These poor levels of CR participation have
      been previously attributed to low referral rates amongst healthcare providers, however even
      within the 30% of eligible patients who become CR participants, the attrition rate is
      currently 50% and only 20% of attendees report long-term behavioural change. The lack of
      subsequent engagement with the desired adaptive behaviours is at a great cost to the National
      Health Service (NHS), with the cost of delivering a "good quality CR service" at £477 per
      patient and the average cardiac readmission costing £3637. Although physical activity (PA)
      has been demonstrated to reduce the risk of secondary cardiac incidents, 80% of CR patients
      fail to maintain regular habitual PA within the first year following a course of CR..

      Similarly, Pulmonary Rehabilitation (PR) has been demonstrated to be an effective
      non-pharmacological intervention for COPD patients, and aims to return the patient to
      independent functioning, reduce disability and improve quality of life. The clinical
      conditions for which PR is routinely offered result in progressive loss of function over
      time. Therefore, any initial beneficial effects of a PR programme are likely to diminish over
      the subsequent eighteen months. Within this time period however, patients who complete PR
      have significantly greater quality of life, PA capacity, and fewer days in hospital relative
      to participants who do not participate in PR . Despite these benefits, uptake and adherence
      to PR is extremely problematic, with studies demonstrating that less than 50% of patients
      referred to PR will complete the course. Additionally, adherence rates reported in randomised
      controlled trials tend to be higher, so even this bleak estimate of adherence may be
      inflated.

      Background Information

      A commonality between CR and PR is the patients' participation in physical activity. Regular
      participation in physical activity (PA) reduces all-cause mortality by 30%, and can help to
      manage over 20 chronic conditions, including CHD, stroke, type 2 diabetes, cancer, obesity,
      mental health problems and musculoskeletal conditions. COPD patients' engagement in
      low-to-moderate intensity daily PA has been shown to enhance their cardiorespiratory health
      and ability for exertion, and reduce dyspnoea symptoms . Additionally, PA reduces cardiac
      mortality by 31%, and has been demonstrated to lower blood pressure, and increase 'good'
      cholesterol in cardiac patients. These effects occur through engagement in relatively low
      levels of activity: 30 minutes, five times per week.

      Despite these far-reaching benefits, patients are less likely than non-symptomatic
      individuals to engage with PA. In 2015, a report by the Academy of Medical Royal Colleges
      portrayed PA as a 'miracle cure', which despite having a better disease risk reduction than
      many drugs, is often overlooked by healthcare providers and their patients. Worryingly, with
      the number of older people with multiple medical problems increasing rapidly, less than a
      third of UK adults over the age of 65 meet the minimum levels of PA.

      Theoretical Underpinning

      Motivation is a key component of behaviour change. With the focus on the motivational aspects
      of behaviour change in mind, Self-Determination Theory (SDT) has become an increasingly
      commonly used theory to design health behaviour change interventions . According to SDT
      individuals adopt or change behaviour on the basis of internal satisfaction and fulfilment,
      termed as intrinsic motivation. Alternatively, individuals are less likely to adopt or change
      behaviour when a reward or inducement provided by an external person is used to compel a
      person to act, known as extrinsic motivation. Environments that support intrinsic motivation
      optimise behavioural effort, persistence and performance. In contrast, environments that
      coerce through rewards serve to diminish behavioural effort, persistence and performance .

      Previous SDT research has demonstrated that intrinsic motivation towards treatment is
      positively associated with adherence to medical regimes among people with chronic illnesses,
      attendance/involvement in an addiction treatment program, and long-term maintenance of weight
      loss among morbidly obese patients. Within physical activity research, intrinsic motivation
      has been found to be strongly associated with physical activity engagement. Similarly,
      increases in intrinsic motivation from pre- to post- exercise referral scheme significantly
      predicted greater adherence to the scheme as well as greater sports-related physical
      activity. The dense body of SDT research in health, including physical activity, suggests
      that interventions underpinned by SDT, should develop and support intrinsic motivation in
      order to optimally motivate engagement with PA.

      Motivational interviewing (MI) is a method of strengthening personal motivation for change,
      and has been shown to be a promising approach for promoting health behaviour change in a
      number of contexts including physical activity promotion. MI comprises several techniques
      used by practitioners to facilitate behaviour change in patients. Some techniques focus on
      the content of the intervention, whereas others focus on techniques reflect the
      practitioner's interpersonal style of delivery. One of the primary roles the MI approach is
      to evoke the patient's arguments for change and to reduce their own arguments for not
      changing.

      Research Critique

      Motivational theories that inform behaviour change (for example, SDT) do not typically feed
      through to into instructor training programmes, particularly in clinical rehabilitation
      settings. Therefore, a significant limitation of motivational theory to date is its ability
      to be translated into clinical practice. Accordingly, it is important that attempts are made
      to ensure motivational theory is translated effectively in clinical practice in order to
      increase patients' motivation for physical activity uptake and adherence in cardiac and
      pulmonary rehabilitation. The current research, therefore, will combine a well-established
      motivational theory (i.e., Self-Determination Theory) with established motivational practice
      (i.e., Motivational Interviewing) in an attempt to integrate theory and practice, offsetting
      Ntoumanis et al's. claims that contemporary motivation research does not typically feed
      through to instructor programmes.

      Previous researches aiming to increase physical activity motivation in rehabilitation have
      predominantly focused on interventions at an individual-level. Whilst it is important not to
      completely disregard this approach, the NHS rehabilitation setting is typically a place where
      clinicians have to facilitate sessions on a group-level. Furthermore, the NHS may not have
      the resources to provide the sufficient level of treatment fidelity that one-to-one
      approaches require in order to be successful. Therefore, the current research will equip
      clinicians with skills to be effective for increasing group-level physical activity
      motivation, as well as on an individual level.

      Motivational-based intervention research for changing increasing physical activity behaviour
      in clinical rehabilitation settings has predominantly focused on intervention effectiveness
      for changing behavioural outcomes. However, the intervention development, delivery and
      content are not often reported, therefore, limiting the applied utility and replication of
      the intervention itself. As such, the current research will pilot and feasibly investigate
      the development of a motivational-based intervention. Doing so will provide a more nuanced
      understanding for motivating cardiac and pulmonary patients' uptake and adherence to physical
      rehabilitation activity. Such information would also be crucial for informing a future RCT
      trial.
observational model: Case-Only
time perspective: Prospective
measure: Percentage enrolment and attendance to rehabilitation
time frame: June 2018-February 2019.
description: Measure of percentage enrolment and attendance to rehabilitation.
measure: Qualitative Impact Evaluation
time frame: June 2018-February 2019. Interviews will be conducted upon discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge
description: Semi-Structured interview with patients and staff.
measure: Treatment Self Regulation Questionnaire (Exercise)
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: The treatment self-regulation questionnaire (TSRQ) assessed autonomous and controlled reasons for participation in the program. The TSRQ has 18 item stems such as: "I am staying in the program because…", followed by several reasons that vary in the extent to which they represent autonomous regulation. An example of more controlled reasons are:"I feel like a failure if I don't". An example of more autonomous reasons are "I believe it's the best way to help myself." Each reason was rated on a 7-point scale ranging from not true at all to very true. Typically, the responses on the autonomous items are summed to form the autonomous regulation score (range 5-35) for the target behavior while responses on the controlled items are summed to form the controlled regulation score (range 8-56). These two subscale scores are used separately.
measure: International Physical Activity Questionnaire Short Version (IPAQ)
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: The IPAQ measures the level of PA across four domains; leisure time PA, domestic and gardening (yard) activities, work- related PA, and transport- related PA. In each domain, the duration (in minutes) and frequency (days) of PA including sitting, walking, moderate and vigorous PA are self-reported.
measure: EuroQol, five dimensions, three levels (EQ-5D-3L)
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: Health related quality of life will be measured using the EuroQol, five dimensions, three levels (EQ-5D-3L). The EQ-5D-3L determines self-assessed problems across five items of mobility, self-care, usual activities, pain/dis- comfort and anxiety/depression. Each item has three levels of severity: 'no problems', 'some problems' and 'severe problems'.
measure: Perceived Competence Scale (Exercising Regularly)
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: The Perceived Competence Scale (PCS) assesses the degree to which patients feel confident about being able to make and maintain their participation in the rehabilitation programme and PA.
measure: Perceived Environmental Supportiveness Scale (PESS)
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: Markland and Tobin (2010) developed the Perceived Environmental Supportiveness Scale (PESS) to assess perceptions of need support provided by exercise practicioners to exercise referral scheme clients. The PESS was designed to explicitly assess the three dimensions of support (autonomy support, structure and involvement) and comprises 15 items with five items assessing each of the three dimensions.
measure: Relatedness to Others in Physical Activity (ROPAS) Scale
time frame: June 2018-February 2019.Questionnaires will be completed upon admission to rehabilitation, discharge (on average 8 weeks following admission to rehabilitation), 3 months post-discharge, 6 months post-discharge.
description: The Relatedness to Others in Physical Activity Scale (ROPAS) (Wilson & Bengoechea, 2010) will be used to assess participants' perceptions of the group climate. Participants responded to 6-items assessing respondents' perception of meaningful connection and belongingness to other group members. Items are rated on a 6-pt likert scale and a priori criteria for summary scores are set at ≥4.5. An example item includes, "I have developed a close bond with others."
measure: Test of Exercise Capacity
time frame: Test will be completed upon admission to rehabilitation, and at discharge (on average 8 weeks following admission to rehabilitation).
description: Patients will complete either an Incremental Shuttle Walking Test (ISWT), six-minute walk test (6MWT), or bike test. In all cases, patients' perceived exertion will be assessed with the 15-point single-item Rating of Perceived Exertion (RPE; Borg, 1998), which ranges from 6 (no exertion at all) to 20 (maximal exertion).
measure: Attendance at Rehabilitation Sessions
time frame: Throughout rehabilitation programme (on average 8 weeks).
description: The number of sessions, over an average of 8 weeks, that each participant attends will be recorded.
arm group label: Phase A, Study One
description: Semi-structured interviews to investigate staff and patients' experiences of participating and facilitating cardiac and pulmonary rehabilitation.
arm group label: Phase A, Study Two
description: Focus group with rehabilitation stakeholders to discuss perceived feasibility and acceptability of the intervention design.
arm group label: Phase A, Study Three
description: Pilot of the intervention, using a group of exercise physiologists external to the community rehabilitation services.
arm group label: Phase B
description: Community rehabilitation service staff will participate in the intervention. Patients will then participate in the rehabilitaiton programme. Physical activity levels of patients will be recorded throughout the rehabilitation programme and for six months post-discharge. Qualitative and quantitative follow-up sessions will patients will take place at discharge (8 weeks after start of rehabilitation), and three and six months post-discharge.
intervention type: Behavioral
intervention name: IPAIR
description: Motivational interview training
arm group label: Phase A, Study Three
arm group label: Phase B
other name: Motivational interview training
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
last name: Adrian W Midgley, PhD
role: Principal Investigator
affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust/ Edge Hill University
last name: Bashir Matata, PhD
role: Principal Investigator
affiliation: Liverpool Heart and Chest Hospital NHS Foundation Trust
facility: 
country: United Kingdom
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PMID: 17160566
citation: British Heart Foundation. (2015). The National Audit of Cardiac Rehabilitation Annual Statistical Report 2015. London. Retrieved from http://www.cardiacrehabilitation.org.uk/docs/2007.pdf
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PMID: 19969157
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PMID: 23943649
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PMID: 10715508
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citation: Hardcastle SJ, Fortier M, Blake N, Hagger MS. Identifying content-based and relational techniques to change behaviour in motivational interviewing. Health Psychol Rev. 2017 Mar;11(1):1-16. doi: 10.1080/17437199.2016.1190659. Epub 2016 Jun 2.
PMID: 27189713
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PMID: 19036552
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PMID: 18824488
citation: Moore SM, Charvat JM, Gordon NH, Pashkow F, Ribisl P, Roberts BL, Rocco M. Effects of a CHANGE intervention to increase exercise maintenance following cardiac events. Ann Behav Med. 2006 Feb;31(1):53-62. doi: 10.1207/s15324796abm3101_9.
PMID: 16472039
citation: National Institute for Health and Clinical Excellence (NICE). (2013). Cardiac rehabilitation services: commissioning guide. London.
citation: Ntoumanis N, Thogersen-Ntoumani C, Quested E, Hancox J. The effects of training group exercise class instructors to adopt a motivationally adaptive communication style. Scand J Med Sci Sports. 2017 Sep;27(9):1026-1034. doi: 10.1111/sms.12713. Epub 2016 Jun 10.
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citation: Rahman RJ, Thogersen-Ntoumani C, Thatcher J, Doust J. Changes in need satisfaction and motivation orientation as predictors of psychological and behavioural outcomes in exercise referral. Psychol Health. 2011 Nov;26(11):1521-39. doi: 10.1080/08870446.2010.538849. Epub 2011 Jun 16.
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PMID: 22726453
citation: The Academy of Medical Royal Colleges. (2015). Exercise: The miracle cure and the role of the doctor in promoting it. Report from the Academy of Medical Royal Colleges. London. Retrieved from http://www.aomrc.org.uk
citation: Yohannes AM, Doherty P, Bundy C, Yalfani A. The long-term benefits of cardiac rehabilitation on depression, anxiety, physical activity and quality of life. J Clin Nurs. 2010 Oct;19(19-20):2806-13. doi: 10.1111/j.1365-2702.2010.03313.x. Epub 2010 Aug 24.
PMID: 20738450
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Cardiovascular Diseases
sharing ipd: No
ipd description: There is no plan to share IPD