<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/NCT03298230</url>
  </required_header>
  <id_info>
    <org_study_id>224506</org_study_id>
    <nct_id>NCT03298230</nct_id>
  </id_info>
  <brief_title>The RESPECT-PAD Trial</brief_title>
  <official_title>A Pilot Randomised Controlled Trial of REmotely SuPervised Exercise Training for Patients With Peripheral Arterial Disease: The RESPECT-PAD Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manchester</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>
      Peripheral arterial disease affects around 25% of the UK population aged over 55. Left&#xD;
      untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly&#xD;
      affects the lower limbs and in the earlier stages of the disease patients can present with a&#xD;
      symptom known as intermittent claudication; pain felt in the legs which stops the patient&#xD;
      from walking past a certain distance. Current National Institute for Healthcare and&#xD;
      Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for&#xD;
      patients with peripheral arterial disease presenting with intermittent claudication.&#xD;
      Supervised exercise employs behaviour changing techniques which enable the patient to modify&#xD;
      their lifestyles, improving their claudication symptoms, quality of life and reducing their&#xD;
      cardiovascular risk. Despite this treatment being significantly more cost-effective than&#xD;
      often employed complex endovascular management, most institutions don't offer such programmes&#xD;
      citing lack of resources and compliance from clinicians and patients alike.&#xD;
&#xD;
      The investigators propose a more cost-effective, resource-savvy solution in the form of&#xD;
      REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the&#xD;
      convenience of their own home, at a time of their choosing but still be supervised via&#xD;
      fitness tracker technology and an online fitness platform. This randomised controlled trial&#xD;
      will attempt to prove its' effectiveness in increasing claudication distance, improving&#xD;
      functional ability, decreasing cardiovascular risk and improving quality of life whilst being&#xD;
      more cost-effective than the currently recognised national first line treatment. This trial&#xD;
      has the potential to revolutionise the management of patients with peripheral arterial&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2018</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">April 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Absolute Claudication Distance</measure>
    <time_frame>At 12 weeks</time_frame>
    <description>Measured using a G-protocol on treadmill testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Absolute Claudication Distance</measure>
    <time_frame>6 months and 1 year.</time_frame>
    <description>Measured using a G-protocol on treadmill testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Initial Claudication Distance</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>Measured using a G-protocol on treadmill testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Line</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>Measured using the Medical Outcomes SF36v2 Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular Risk Factors</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>Measured by calculating change in waist circumference and BMI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>Measured by the cost of the interventions in each group, including resource and staffing costs. Also includes any unplanned admissions and procedures carried out due to a complication of the disease of interest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Habitual physical activity levels</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>As measured by the physical activity scale for the elderly questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>12 weeks, 6 months and one year</time_frame>
    <description>As measured by using the amount of exercise in minutes performed over the 12 weeks, divided by the number of minutes of exercise prescribed x100</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Peripheral Arterial Disease</condition>
  <condition>Cardiovascular Diseases</condition>
  <arm_group>
    <arm_group_label>REmotely SuPervised Exercise Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>12- week home based exercise programme consisting of bi-weekly, hourly sessions at the time and place of the participant's choosing. They will wear a fitness tracker which will automatically upload their exercise data to an online platform which can be monitored by the research team and used to provide additional motivation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Supervised Exercise Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>REmotely SuPervised Exercise Training</intervention_name>
    <description>As described in the Arms section.</description>
    <arm_group_label>REmotely SuPervised Exercise Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Supervised Exercise Training</intervention_name>
    <description>As described in the Arms section.</description>
    <arm_group_label>Supervised Exercise Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients willing and able to undertake supervised or home-based exercise training aged&#xD;
             between 40 and 85&#xD;
&#xD;
          2. Positive Edinburgh questionnaire for intermittent claudication (APPENDIX H)&#xD;
&#xD;
          3. Proven peripheral arterial disease on diagnostic imaging&#xD;
&#xD;
          4. Ankle Brachial Pressure Index (ABPI) &lt;0.9&#xD;
&#xD;
          5. Fontaine Classification (APPENDIX I) of PAD Stage II&#xD;
&#xD;
          6. Conservative management plan agreed for by Consultant Vascular Surgeon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Critical limb ischaemia&#xD;
&#xD;
          2. Asymptomatic peripheral arterial disease&#xD;
&#xD;
          3. Ambulation limited by co-morbid condition other than claudication:&#xD;
&#xD;
             Severe coronary artery disease, angina pectoris, chronic lung disease, neurological&#xD;
             disorder, arthritis, amputation&#xD;
&#xD;
          4. Contraindication to exercise training (AHA guidelines):71 acute MI (within 1 week),&#xD;
             unstable angina, uncontrolled cardiac arrhythmias causing symptoms or haemodynamic&#xD;
             compromise, active endocarditis, symptomatic severe aortic stenosis, acute pulmonary&#xD;
             embolus, acute noncardiac disorder than may be aggravated by exercise such as&#xD;
             infection, thyrotoxicosis, acute myocarditis, known physical disability that would&#xD;
             preclude safe and adequate testing, known thrombosis of the lower limb, known left&#xD;
             main stem coronary stenosis, moderate stenotic valvular heart disease, pulmonary&#xD;
             hypertension, hypertrophic cardiomyopathy, atrio-ventricular block.&#xD;
&#xD;
          5. Psychiatric disorder precluding them from consenting for research and/or exercise&#xD;
             training&#xD;
&#xD;
          6. Arterial reconstruction in the previous 12 months or planned within the next 6 months.&#xD;
&#xD;
          7. Recent or upcoming major surgery (within 3 months)&#xD;
&#xD;
          8. Unwilling or unable to attend/perform exercise training&#xD;
&#xD;
          9. Non-atherosclerotic cause of PAD&#xD;
&#xD;
         10. Other significant medical problems which impact on the patient's ability to complete a&#xD;
             12-week exercise programme, which could include:&#xD;
&#xD;
        malignancy, chronic renal disease, chronic liver disease or anaemia, active substance&#xD;
        abuse, dementia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Adam Haque</last_name>
    <phone>01612915848</phone>
    <email>adam.haque@manchester.ac.uk</email>
  </overall_contact>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>October 15, 2018</last_update_submitted>
  <last_update_submitted_qc>October 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Charles McCollum</investigator_full_name>
    <investigator_title>Professor of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Peripheral Arterial Disease</mesh_term>
    <mesh_term>Peripheral Vascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03298230
org study id: 224506
nct id: NCT03298230
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Peripheral arterial disease affects around 25% of the UK population aged over 55. Left
      untreated it can lead to debilitating pain, gangrene, amputation and death. It most commonly
      affects the lower limbs and in the earlier stages of the disease patients can present with a
      symptom known as intermittent claudication; pain felt in the legs which stops the patient
      from walking past a certain distance. Current National Institute for Healthcare and
      Excellence (NICE) guidelines recommend Supervised Exercise as first line treatment for
      patients with peripheral arterial disease presenting with intermittent claudication.
      Supervised exercise employs behaviour changing techniques which enable the patient to modify
      their lifestyles, improving their claudication symptoms, quality of life and reducing their
      cardiovascular risk. Despite this treatment being significantly more cost-effective than
      often employed complex endovascular management, most institutions don't offer such programmes
      citing lack of resources and compliance from clinicians and patients alike.

      The investigators propose a more cost-effective, resource-savvy solution in the form of
      REmotely SuPervised ExerCise Training (RESPECT). This allows the patient to exercise in the
      convenience of their own home, at a time of their choosing but still be supervised via
      fitness tracker technology and an online fitness platform. This randomised controlled trial
      will attempt to prove its' effectiveness in increasing claudication distance, improving
      functional ability, decreasing cardiovascular risk and improving quality of life whilst being
      more cost-effective than the currently recognised national first line treatment. This trial
      has the potential to revolutionise the management of patients with peripheral arterial
      disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Absolute Claudication Distance
time frame: At 12 weeks
description: Measured using a G-protocol on treadmill testing
measure: Absolute Claudication Distance
time frame: 6 months and 1 year.
description: Measured using a G-protocol on treadmill testing
measure: Initial Claudication Distance
time frame: 12 weeks, 6 months and one year
description: Measured using a G-protocol on treadmill testing
measure: Health-related Quality of Line
time frame: 12 weeks, 6 months and one year
description: Measured using the Medical Outcomes SF36v2 Questionnaire
measure: Cardiovascular Risk Factors
time frame: 12 weeks, 6 months and one year
description: Measured by calculating change in waist circumference and BMI
measure: Cost
time frame: 12 weeks, 6 months and one year
description: Measured by the cost of the interventions in each group, including resource and staffing costs. Also includes any unplanned admissions and procedures carried out due to a complication of the disease of interest
measure: Habitual physical activity levels
time frame: 12 weeks, 6 months and one year
description: As measured by the physical activity scale for the elderly questionnaire.
measure: Adherence
time frame: 12 weeks, 6 months and one year
description: As measured by using the amount of exercise in minutes performed over the 12 weeks, divided by the number of minutes of exercise prescribed x100
arm group label: REmotely SuPervised Exercise Training
arm group type: Experimental
description: 12- week home based exercise programme consisting of bi-weekly, hourly sessions at the time and place of the participant's choosing. They will wear a fitness tracker which will automatically upload their exercise data to an online platform which can be monitored by the research team and used to provide additional motivation.
arm group label: Supervised Exercise Training
arm group type: Active Comparator
description: As per NICE guidance. 12 week, bi-weekly, one hour sessions of supervised exercise training.
intervention type: Behavioral
intervention name: REmotely SuPervised Exercise Training
description: As described in the Arms section.
arm group label: REmotely SuPervised Exercise Training
intervention type: Behavioral
intervention name: Supervised Exercise Training
description: As described in the Arms section.
arm group label: Supervised Exercise Training
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Adam Haque
phone: 01612915848
email: adam.haque@manchester.ac.uk
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Charles McCollum
investigator title: Professor of Surgery
mesh term: Cardiovascular Diseases
mesh term: Peripheral Arterial Disease
mesh term: Peripheral Vascular Diseases
sharing ipd: Undecided