<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/NCT03262168</url>
  </required_header>
  <id_info>
    <org_study_id>GoldenJNH</org_study_id>
    <nct_id>NCT03262168</nct_id>
  </id_info>
  <brief_title>Supported Exercise Programme for Adults With Congenital Heart Disease</brief_title>
  <acronym>SEACHange</acronym>
  <official_title>Supported Exercise Programme for Adults With Congenital Heart Disease (SEA CHange)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Golden Jubilee National Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Golden Jubilee National Hospital</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>
      This study will evaluate if the introduction of a supported exercise programme can improve&#xD;
      physical and psychological well-being for adults with congenital heart disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Congenital heart disease (CHD) describes heart defects present from birth. The majority of&#xD;
      affected patients will require lifelong care to not only manage their medical condition, but&#xD;
      also to offer support and guidance on living with their specific heart condition. Exercise&#xD;
      and physical activity is one such area where patients often require support and advice.&#xD;
      Recommendations are in place for health care providers to promote physical activity for this&#xD;
      patient population. However, many health care providers find it difficult to know what level&#xD;
      of exercise is reasonable or how to escalate current exercise programmes.&#xD;
&#xD;
      The benefits of regular exercise are well known and evidence suggests that even a modest&#xD;
      increase in physical activity can reduce morbidity, improve psychological wellbeing and&#xD;
      protect against cardiovascular disease.&#xD;
&#xD;
      This pilot study will determine the feasibility of introducing a supported exercise programme&#xD;
      to clinical practice. The investigators aim to assess if improvements can be made in both&#xD;
      physical and psychological well-being for adults with CHD who are living in Scotland. After&#xD;
      initial assessment and baseline measurements are obtained, participants will follow a twelve&#xD;
      week individualised programme. The investigators will keep in regular contact with the&#xD;
      participant throughout and arrange interval and final assessments. The baseline measurements&#xD;
      will be repeated during the final assessment at 12 weeks. Investigators anticipate that the&#xD;
      study will also help to establish a programme that will help to improve the way adults who&#xD;
      were born with a heart condition can be supported with physical activity on a long term&#xD;
      basis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2017</start_date>
  <completion_date type="Actual">December 21, 2018</completion_date>
  <primary_completion_date type="Actual">December 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Participants compete a six minute walk test (6MWT). Those who achieve less than 450 metres will be assigned to study group one. Participants who achieve greater than 450 metres on 6MWT will be assigned to study group two.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attendance rate</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Determine the feasibility of introducing a supported exercise programme in to clinical practice. This will be measured through attendance to the programme and interaction with the online resource.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Attrition rate</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in six minute walk test (6MWT)</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in six minute walk test distance (metres) between 0 and 12 weeks. Offers a simple, readily available and cost effective method for objective evaluation of functional exercise capacity during daily activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Sniff Nasal Inspiratory Pressure (SNIP)</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in Sniff Nasal Inspiratory Pressure (SNIP) between 0 and 12 weeks (study group one). Measured in cmH2O and is used to measure inspiratory muscle strength.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Grip Strength</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in grip strength. This is measured in pounds (lbs) using a myometer. It is a recognized method of assessing overall nutritional status and health in subjects with medical conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there an improvement in level of psychological distress</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in level of depression (measured using PHQ- 9 questionnaire). It is a reliable and validated self report questionnaire used to help clinicians screen for depression disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there an improvement in level of psychological distress</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in level of anxiety (measured using GAD-7 questionnaire). The GAD -7 is a self report questionnaire used to identify probable cases of generalised anxiety disorder. Recognised as a valid and reliable screening tool</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body mass Index (BMI)</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in body mass index (measured in kg/m2). Weight (kgs) and height (metres) will be combined to report BMI in kg/m2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in body weight (measured in kg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there an improvement in bicep strength</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in bicep strength. This is measured in newtons (N) using a non invasive strain guage/myometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is there an improvement in quadricep strength</measure>
    <time_frame>12 weeks (for each phase)</time_frame>
    <description>Change in quadricep strength. This is measured in newtons (N) using a non invasive strain guage/myometer</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">28</enrollment>
  <condition>Congenital Disorder</condition>
  <condition>Heart Diseases</condition>
  <arm_group>
    <arm_group_label>Study Group One</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six Minute Walk Test distance &lt;450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group Two</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six Minute Walk Test distance &gt;450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group One - phase 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six Minute Walk Test distance &lt;450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group Two - phase 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Six Minute Walk Test distance &gt;450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise Programme</intervention_name>
    <description>Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.</description>
    <arm_group_label>Study Group One</arm_group_label>
    <arm_group_label>Study Group One - phase 2</arm_group_label>
    <arm_group_label>Study Group Two</arm_group_label>
    <arm_group_label>Study Group Two - phase 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Living in Scotland&#xD;
&#xD;
          -  Diagnosis of congenital heart disease&#xD;
&#xD;
          -  Walks less than 450 metres on a 6 minute walk test (Group 1)&#xD;
&#xD;
          -  Walks more than 450 metres on a 6 minute walk test (Group 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No access to internet or telephone&#xD;
&#xD;
          -  Non English speaking (If the pilot study is successful, we anticipate that materials&#xD;
             and programmes could be translated and accessible to non English speakers)&#xD;
&#xD;
          -  Vulnerable adults&#xD;
&#xD;
          -  Severe aortic stenosis or severe left ventricular outflow tract obstruction (LVOTO)&#xD;
&#xD;
          -  Eisenmenger Physiology (ongoing study recruitment with SPVU)&#xD;
&#xD;
          -  Currently prescribed Advanced Pulmonary Vasodilator therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maureen Mason, MSc</last_name>
    <role>Study Chair</role>
    <affiliation>Golden Jubilee Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Golden Jubilee National Hospital</name>
      <address>
        <city>Clydebank</city>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>April 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>July 30, 2019</last_update_submitted>
  <last_update_submitted_qc>July 30, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Exercise</keyword>
  <keyword>Physical Activity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share individual data</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/NCT03262168
org study id: GoldenJNH
nct id: NCT03262168
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will evaluate if the introduction of a supported exercise programme can improve
      physical and psychological well-being for adults with congenital heart disease.
Congenital heart disease (CHD) describes heart defects present from birth. The majority of
      affected patients will require lifelong care to not only manage their medical condition, but
      also to offer support and guidance on living with their specific heart condition. Exercise
      and physical activity is one such area where patients often require support and advice.
      Recommendations are in place for health care providers to promote physical activity for this
      patient population. However, many health care providers find it difficult to know what level
      of exercise is reasonable or how to escalate current exercise programmes.

      The benefits of regular exercise are well known and evidence suggests that even a modest
      increase in physical activity can reduce morbidity, improve psychological wellbeing and
      protect against cardiovascular disease.

      This pilot study will determine the feasibility of introducing a supported exercise programme
      to clinical practice. The investigators aim to assess if improvements can be made in both
      physical and psychological well-being for adults with CHD who are living in Scotland. After
      initial assessment and baseline measurements are obtained, participants will follow a twelve
      week individualised programme. The investigators will keep in regular contact with the
      participant throughout and arrange interval and final assessments. The baseline measurements
      will be repeated during the final assessment at 12 weeks. Investigators anticipate that the
      study will also help to establish a programme that will help to improve the way adults who
      were born with a heart condition can be supported with physical activity on a long term
      basis.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Participants compete a six minute walk test (6MWT). Those who achieve less than 450 metres will be assigned to study group one. Participants who achieve greater than 450 metres on 6MWT will be assigned to study group two.
primary purpose: Other
masking: None (Open Label)
measure: Attendance rate
time frame: 12 weeks (for each phase)
description: Determine the feasibility of introducing a supported exercise programme in to clinical practice. This will be measured through attendance to the programme and interaction with the online resource.
measure: Attrition rate
time frame: 12 weeks (for each phase)
description: Determine the feasibility of introducing a supported exercise programme by assessing attrition rate throughout the study period.
measure: Change in six minute walk test (6MWT)
time frame: 12 weeks (for each phase)
description: Change in six minute walk test distance (metres) between 0 and 12 weeks. Offers a simple, readily available and cost effective method for objective evaluation of functional exercise capacity during daily activity.
measure: Change in Sniff Nasal Inspiratory Pressure (SNIP)
time frame: 12 weeks (for each phase)
description: Change in Sniff Nasal Inspiratory Pressure (SNIP) between 0 and 12 weeks (study group one). Measured in cmH2O and is used to measure inspiratory muscle strength.
measure: Change in Grip Strength
time frame: 12 weeks (for each phase)
description: Change in grip strength. This is measured in pounds (lbs) using a myometer. It is a recognized method of assessing overall nutritional status and health in subjects with medical conditions.
measure: Is there an improvement in level of psychological distress
time frame: 12 weeks (for each phase)
description: Change in level of depression (measured using PHQ- 9 questionnaire). It is a reliable and validated self report questionnaire used to help clinicians screen for depression disorder.
measure: Is there an improvement in level of psychological distress
time frame: 12 weeks (for each phase)
description: Change in level of anxiety (measured using GAD-7 questionnaire). The GAD -7 is a self report questionnaire used to identify probable cases of generalised anxiety disorder. Recognised as a valid and reliable screening tool
measure: Body mass Index (BMI)
time frame: 12 weeks (for each phase)
description: Change in body mass index (measured in kg/m2). Weight (kgs) and height (metres) will be combined to report BMI in kg/m2
measure: Body weight
time frame: 12 weeks (for each phase)
description: Change in body weight (measured in kg)
measure: Is there an improvement in bicep strength
time frame: 12 weeks (for each phase)
description: Change in bicep strength. This is measured in newtons (N) using a non invasive strain guage/myometer
measure: Is there an improvement in quadricep strength
time frame: 12 weeks (for each phase)
description: Change in quadricep strength. This is measured in newtons (N) using a non invasive strain guage/myometer
arm group label: Study Group One
arm group type: Other
description: Six Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
arm group label: Study Group Two
arm group type: Other
description: Six Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
arm group label: Study Group One - phase 2
arm group type: Other
description: Six Minute Walk Test distance <450metres. Exercise programme including inspiratory muscle trainer for 12 weeks. Contact weekly (via phone or email).
arm group label: Study Group Two - phase 2
arm group type: Other
description: Six Minute Walk Test distance >450metres. Exercise programme including walking for 12 weeks. Contact every second week (via phone or email).
intervention type: Other
intervention name: Exercise Programme
description: Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
arm group label: Study Group One
arm group label: Study Group One - phase 2
arm group label: Study Group Two
arm group label: Study Group Two - phase 2
criteria: 
gender: All
minimum age: 16 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Maureen Mason, MSc
role: Study Chair
affiliation: Golden Jubilee Research Institute
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No
ipd description: No plan to share individual data