xml: <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/NCT05961943</url>
    </required_header>
    <id_info>
      <org_study_id>C.A.2970</org_study_id>
      <nct_id>NCT05961943</nct_id>
    </id_info>
    <brief_title>RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients</brief_title>
    <official_title>Feasibility, Acceptability, and Effectiveness of the &quot;RESPONSE-2&quot; Program in Reducing Sedentary Behavior in Patients With Peripheral Arterial Disease: A Mixed Methods Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute for Prevention and Cardiovascular Health, Ireland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>National Institute for Prevention and Cardiovascular Health, Ireland</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>
        The RESPONSE-2- peripheral arterial disease (PAD) program will be implemented to modify&#xD;
        sedentary time in patients with PAD. It is an adapted version of the RESPONSE that aims to&#xD;
        reduce sedentary behavior in individuals with diabetes. The RESPONSE-2-PAD is a&#xD;
        multicomponent program involves an online educational component, sedentary reminders and&#xD;
        health coaching sessions, which are designed to modify patients' sedentary behavior.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Peripheral arterial disease (PAD) affects more than 200 million patients globally. PAD is&#xD;
        characterized by a reduction in arterial perfusion caused by atherosclerotic plaque. PAD can&#xD;
        negatively impact a person's quality of life due to the functional limitations caused by&#xD;
        symptoms and the possibility of losing limbs. It also increases the risk of major adverse&#xD;
        cardiac events (MACE). Many risk factors have been identified for PAD. Recently, sedentary&#xD;
        behavior (SB) has emerged as an important risk factor for cardiovascular disease (CVD)&#xD;
        including PAD independent to physical activity.&#xD;
  &#xD;
        Studies have reported that patients with PAD have significantly higher levels of total&#xD;
        sedentary time (ST) compared to those without PAD. Consequently, early intervention and&#xD;
        management strategies, including addressing sedentary behavior, are crucial to prevent&#xD;
        unfavorable outcomes in patients with established PAD as it is possible for an individual to&#xD;
        engage in a significant amount of moderate to vigorous physical activity and have high levels&#xD;
        of sedentary time within the same day.&#xD;
  &#xD;
        The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living&#xD;
        with peripheral arterial disease. They will be recruited through the vascular services at&#xD;
        University Hospital Galway. Those potentially interested will be provided with an information&#xD;
        sheet. Participants will take part in an initial assessment which will measure their sitting&#xD;
        time, physical activity participation and their six-minute walking distance. They will then&#xD;
        take part in a 12-week individually tailored, coaching-based intervention. This intervention&#xD;
        will be delivered remotely. The intervention involves the use of an activity&#xD;
        tracker(sedentary reminder) and an online structured education program coupled with coaching&#xD;
        calls (10-15minutes) that review sitting time and activity goals weekly. At 12-weeks all&#xD;
        participants will be invited to a follow up assessment where sitting time, activity&#xD;
        participation and six-minute walking distance will be remeasured. Patients will also be&#xD;
        invited to take part in a semi-structured interview to explore their views and opinions of&#xD;
        the program and its acceptability. At six months all patients will be invited for a final&#xD;
        follow-up measurement of their sitting time, physical activity participation and six-minute&#xD;
        walking distance in order to evaluate longer term changes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">August 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Study recruitment will be conducted at the vascular outpatient clinic at Galway University Hospitals (GUH), Ireland. Those who consent will then be invited to attend a baseline assessment. All participants will be provided with an activPAL accelerometer device to use for seven consecutive days. Patients will also complete the six-minute walk test (6-MWT). Participants will then commence the 12-week tailored intervention to empower participants to reduce/interrupt their sedentary time. Participants will have access to an online education session via the RESPONSE-2-PAD link. The researcher will support and motivate participants to reduce/interrupt their sitting time by contacting them through phone or video coaching calls once a week, on average lasting 10-15 minutes. an activity tracker will be used as a sedentary reminder. Participants will be followed up at 12-weeks and again at six months.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.</measure>
      <time_frame>Participants recruited for 6 months. Sedentary time assessed at baseline, after 12-week intervention, and at 6-month follow-up. Comprehensive evaluation of sedentary behavior throughout the study.</time_frame>
      <description>This study will assess sedentary time in hours at baseline. After a 12-week intervention and a 6-month follow-up, sedentary time will be reassessed using the activPAL accelerometer, as done at baseline. Data analysis will evaluate changes in sedentary time from baseline to post-intervention using statistical methods to assess the effectiveness of the multicomponent intervention.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.</measure>
      <time_frame>At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.</time_frame>
      <description>This study aims to evaluate the level of participant engagement in the RESPONSE-2-PAD intervention, which is designed to reduce sedentary time. Through a semi structured interview. We will assess participants' involvement, motivation, and adherence to the intervention.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).</measure>
      <time_frame>Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.</time_frame>
      <description>Moderate to vigorous physical activity (MVPA) hours will be assessed at baseline. After the intervention period (12 weeks) and 6 months follow up will be reassessed using the activPAL accelerometer as before the intervention. Then data will be analyzed to assess the changes in MVPA from baseline to post-intervention. Statistical methods will be employed to compare pre- and post-intervention MVPA and evaluate the effectiveness of the multicomponent intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.</measure>
      <time_frame>6-Minute Walk Test (6MWT) Assessments: Baseline: Before starting the intervention Post-Intervention: At the end of the 12-week intervention period Follow-Up: 6 months after the completion of the intervention</time_frame>
      <description>This study aims to evaluate the effectiveness of the RESPONSE-2-PAD program in improving symptom-free walking distance using the six-minute walking test (6MWT). The assessment will include measuring total meters scored, initial claudication distance, and absolute claudication distance in participants with peripheral arterial disease (PAD).</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Peripheral Arterial Disease</condition>
    <condition>Sedentary Behavior</condition>
    <condition>Sedentary Time</condition>
    <condition>Peripheral Arterial Occlusive Disease</condition>
    <arm_group>
      <arm_group_label>RESPONSE-2-PAD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants will use the activPAL accelerometer to quantify sedentary time/physical activity. The 6-minute-walk test will be assessed. Participants will receive the 12 week tailored intervention (RESPONSE-2-PAD link, coaching calls and activity tracker). Participants will be followed up at 12-weeks and again at six months.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RESPONSE-2-PAD</intervention_name>
      <description>The RESPONSE-2-PAD program will undergo evaluation through a pilot study includes 50 patients living with peripheral arterial disease. Participants will take part in an initial assessment which will measure their sedentary time/physical activity using activPAL and their six-minute walking distance. They will then take part in a 12-week tailored, coaching-based intervention delivered remotely. The intervention involves the use of an activity tracker (sedentary reminder) and an online structured education program coupled with coaching calls that review sedentary time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment. Participants will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability. At six months all patients will be invited for a final follow-up measurements.</description>
      <arm_group_label>RESPONSE-2-PAD</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults (≥18 years),&#xD;
  &#xD;
            2. Symptomatic patients with established peripheral arterial disease. PAD is confirmed by&#xD;
               any of the following:&#xD;
  &#xD;
                 -  Ankle-brachial index (ABI) of less than 0.90 in at least one lower extremity&#xD;
  &#xD;
                 -  Toe brachial index of less than 0.60&#xD;
  &#xD;
                 -  Arterial occlusive disease in one lower extremity by duplex ultrasonography,&#xD;
                    computed tomographic angiography or magnetic resonance angiography.&#xD;
  &#xD;
            3. Willing and able to give informed consent.&#xD;
  &#xD;
            4. Can read and speak English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. patients with significant PAD in the form of rest pain.&#xD;
  &#xD;
            2. Any impairments that severely affect mobility (e.g., wheelchair bound).&#xD;
  &#xD;
            3. Cognitive impairments revealed by medical records.&#xD;
  &#xD;
            4. Significant comorbid disease that would significantly impair the ability to&#xD;
               participate in activity.&#xD;
  &#xD;
            5. Pregnant / lactating females.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jennifer Jones</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Galway</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wael Tawfick</last_name>
      <role>Study Director</role>
      <affiliation>University of Galway</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Charlotte Edwardson</last_name>
      <role>Study Chair</role>
      <affiliation>University of Leicester</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marwa Said</last_name>
      <phone>00353877374710</phone>
      <email>m.said2@nuigalway.ie</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Institute for prevention and Cardiovascular Health</name>
        <address>
          <city>Galway</city>
          <zip>H91 FF68</zip>
          <country>Ireland</country>
        </address>
      </facility>
      <contact>
        <last_name>Jennifer Jones</last_name>
        <phone>0035391893299</phone>
        <email>Jennifer.jones@universityofgalway.ie</email>
      </contact>
      <contact_backup>
        <last_name>Wael Tawfick</last_name>
        <phone>0035391542376</phone>
        <email>wael.tawfick@hse.ie</email>
      </contact_backup>
      <investigator>
        <last_name>Jennifer Jones</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Wael Tawfick</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marwa Said</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Ireland</country>
    </location_countries>
    <reference>
      <citation>Bailey DP, Edwardson CL, Pappas Y, Dong F, Hewson DJ, Biddle SJH, Brierley ML, Chater AM. A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):76. doi: 10.1186/s40814-021-00816-0.</citation>
      <PMID>33741077</PMID>
    </reference>
    <reference>
      <citation>Chastin SFM, Dontje ML, Skelton DA, Cukic I, Shaw RJ, Gill JMR, Greig CA, Gale CR, Deary IJ, Der G, Dall PM; Seniors USP team. Systematic comparative validation of self-report measures of sedentary time against an objective measure of postural sitting (activPAL). Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):21. doi: 10.1186/s12966-018-0652-x.</citation>
      <PMID>29482617</PMID>
    </reference>
    <reference>
      <citation>Martin A, Fitzsimons C, Jepson R, Saunders DH, van der Ploeg HP, Teixeira PJ, Gray CM, Mutrie N; EuroFIT consortium. Interventions with potential to reduce sedentary time in adults: systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1056-63. doi: 10.1136/bjsports-2014-094524. Epub 2015 Apr 23.</citation>
      <PMID>25907181</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 10, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>peripheral arterial disease</keyword>
    <keyword>sedentary lifestyle</keyword>
    <keyword>Sitting time</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peripheral Arterial Disease</mesh_term>
      <mesh_term>Peripheral Vascular Diseases</mesh_term>
      <mesh_term>Arterial Occlusive Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Only the relevant data will be collected and stored in Galway university hospital. The data relevant to this study will only be stored for 5 more years after the thesis is written and the research has been published in peer-reviewed journals.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Data will be available to the other researchers on request for 5 years</ipd_time_frame>
      <ipd_access_criteria>The data will be in an encrypted file and will be stored at a secure database in Galway University Hospital. Only the coded data information will be shared.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961943
  org study id: C.A.2970
  nct id: NCT05961943
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The RESPONSE-2- peripheral arterial disease (PAD) program will be implemented to modify
        sedentary time in patients with PAD. It is an adapted version of the RESPONSE that aims to
        reduce sedentary behavior in individuals with diabetes. The RESPONSE-2-PAD is a
        multicomponent program involves an online educational component, sedentary reminders and
        health coaching sessions, which are designed to modify patients' sedentary behavior.
  Peripheral arterial disease (PAD) affects more than 200 million patients globally. PAD is
        characterized by a reduction in arterial perfusion caused by atherosclerotic plaque. PAD can
        negatively impact a person's quality of life due to the functional limitations caused by
        symptoms and the possibility of losing limbs. It also increases the risk of major adverse
        cardiac events (MACE). Many risk factors have been identified for PAD. Recently, sedentary
        behavior (SB) has emerged as an important risk factor for cardiovascular disease (CVD)
        including PAD independent to physical activity.
  
        Studies have reported that patients with PAD have significantly higher levels of total
        sedentary time (ST) compared to those without PAD. Consequently, early intervention and
        management strategies, including addressing sedentary behavior, are crucial to prevent
        unfavorable outcomes in patients with established PAD as it is possible for an individual to
        engage in a significant amount of moderate to vigorous physical activity and have high levels
        of sedentary time within the same day.
  
        The RESPONSE-2-PAD program will be evaluated in a pilot study involving 50 patients living
        with peripheral arterial disease. They will be recruited through the vascular services at
        University Hospital Galway. Those potentially interested will be provided with an information
        sheet. Participants will take part in an initial assessment which will measure their sitting
        time, physical activity participation and their six-minute walking distance. They will then
        take part in a 12-week individually tailored, coaching-based intervention. This intervention
        will be delivered remotely. The intervention involves the use of an activity
        tracker(sedentary reminder) and an online structured education program coupled with coaching
        calls (10-15minutes) that review sitting time and activity goals weekly. At 12-weeks all
        participants will be invited to a follow up assessment where sitting time, activity
        participation and six-minute walking distance will be remeasured. Patients will also be
        invited to take part in a semi-structured interview to explore their views and opinions of
        the program and its acceptability. At six months all patients will be invited for a final
        follow-up measurement of their sitting time, physical activity participation and six-minute
        walking distance in order to evaluate longer term changes.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Study recruitment will be conducted at the vascular outpatient clinic at Galway University Hospitals (GUH), Ireland. Those who consent will then be invited to attend a baseline assessment. All participants will be provided with an activPAL accelerometer device to use for seven consecutive days. Patients will also complete the six-minute walk test (6-MWT). Participants will then commence the 12-week tailored intervention to empower participants to reduce/interrupt their sedentary time. Participants will have access to an online education session via the RESPONSE-2-PAD link. The researcher will support and motivate participants to reduce/interrupt their sitting time by contacting them through phone or video coaching calls once a week, on average lasting 10-15 minutes. an activity tracker will be used as a sedentary reminder. Participants will be followed up at 12-weeks and again at six months.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Evaluating the impact of the Multicomponent Intervention (RESPONSE-2-PAD) on sedentary time in individuals with PAD.
  time frame: Participants recruited for 6 months. Sedentary time assessed at baseline, after 12-week intervention, and at 6-month follow-up. Comprehensive evaluation of sedentary behavior throughout the study.
  description: This study will assess sedentary time in hours at baseline. After a 12-week intervention and a 6-month follow-up, sedentary time will be reassessed using the activPAL accelerometer, as done at baseline. Data analysis will evaluate changes in sedentary time from baseline to post-intervention using statistical methods to assess the effectiveness of the multicomponent intervention.
  measure: Assessing the participant involvement in RESPONSE-2-PAD Intervention to Reduce Sedentary Time.
  time frame: At the end of the 6-month follow-up period, participants will be interviewed to gather qualitative feedback.
  description: This study aims to evaluate the level of participant engagement in the RESPONSE-2-PAD intervention, which is designed to reduce sedentary time. Through a semi structured interview. We will assess participants' involvement, motivation, and adherence to the intervention.
  measure: Assessing the change in physical activity level in individuals with PAD using a Multicomponent Intervention (RESPONSE-2-PAD).
  time frame: Participants recruited for 6 months. MVPA assessed at baseline, after 12-week intervention, and at 6-month follow-up.
  description: Moderate to vigorous physical activity (MVPA) hours will be assessed at baseline. After the intervention period (12 weeks) and 6 months follow up will be reassessed using the activPAL accelerometer as before the intervention. Then data will be analyzed to assess the changes in MVPA from baseline to post-intervention. Statistical methods will be employed to compare pre- and post-intervention MVPA and evaluate the effectiveness of the multicomponent intervention.
  measure: Assessing the Efficacy of the RESPONSE-2-PAD Program Using the 6-Minute Walk Test (6MWT) to Improve Symptom-Free Walking Distance.
  time frame: 6-Minute Walk Test (6MWT) Assessments: Baseline: Before starting the intervention Post-Intervention: At the end of the 12-week intervention period Follow-Up: 6 months after the completion of the intervention
  description: This study aims to evaluate the effectiveness of the RESPONSE-2-PAD program in improving symptom-free walking distance using the six-minute walking test (6MWT). The assessment will include measuring total meters scored, initial claudication distance, and absolute claudication distance in participants with peripheral arterial disease (PAD).
  arm group label: RESPONSE-2-PAD
  arm group type: Experimental
  description: All participants will use the activPAL accelerometer to quantify sedentary time/physical activity. The 6-minute-walk test will be assessed. Participants will receive the 12 week tailored intervention (RESPONSE-2-PAD link, coaching calls and activity tracker). Participants will be followed up at 12-weeks and again at six months.
  intervention type: Behavioral
  intervention name: RESPONSE-2-PAD
  description: The RESPONSE-2-PAD program will undergo evaluation through a pilot study includes 50 patients living with peripheral arterial disease. Participants will take part in an initial assessment which will measure their sedentary time/physical activity using activPAL and their six-minute walking distance. They will then take part in a 12-week tailored, coaching-based intervention delivered remotely. The intervention involves the use of an activity tracker (sedentary reminder) and an online structured education program coupled with coaching calls that review sedentary time and activity goals weekly. At 12-weeks all participants will be invited to a follow up assessment. Participants will also be invited to take part in a semi-structured interview to explore their views and opinions of the program and its acceptability. At six months all patients will be invited for a final follow-up measurements.
  arm group label: RESPONSE-2-PAD
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jennifer Jones
  role: Principal Investigator
  affiliation: University of Galway
  last name: Wael Tawfick
  role: Study Director
  affiliation: University of Galway
  last name: Charlotte Edwardson
  role: Study Chair
  affiliation: University of Leicester
  last name: Marwa Said
  phone: 00353877374710
  email: m.said2@nuigalway.ie
  facility: 
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: Ireland
  citation: Bailey DP, Edwardson CL, Pappas Y, Dong F, Hewson DJ, Biddle SJH, Brierley ML, Chater AM. A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol. Pilot Feasibility Stud. 2021 Mar 19;7(1):76. doi: 10.1186/s40814-021-00816-0.
  PMID: 33741077
  citation: Chastin SFM, Dontje ML, Skelton DA, Cukic I, Shaw RJ, Gill JMR, Greig CA, Gale CR, Deary IJ, Der G, Dall PM; Seniors USP team. Systematic comparative validation of self-report measures of sedentary time against an objective measure of postural sitting (activPAL). Int J Behav Nutr Phys Act. 2018 Feb 26;15(1):21. doi: 10.1186/s12966-018-0652-x.
  PMID: 29482617
  citation: Martin A, Fitzsimons C, Jepson R, Saunders DH, van der Ploeg HP, Teixeira PJ, Gray CM, Mutrie N; EuroFIT consortium. Interventions with potential to reduce sedentary time in adults: systematic review and meta-analysis. Br J Sports Med. 2015 Aug;49(16):1056-63. doi: 10.1136/bjsports-2014-094524. Epub 2015 Apr 23.
  PMID: 25907181
  responsible party type: Sponsor
  mesh term: Peripheral Arterial Disease
  mesh term: Peripheral Vascular Diseases
  mesh term: Arterial Occlusive Diseases
  sharing ipd: Yes
  ipd description: Only the relevant data will be collected and stored in Galway university hospital. The data relevant to this study will only be stored for 5 more years after the thesis is written and the research has been published in peer-reviewed journals.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Data will be available to the other researchers on request for 5 years
  ipd access criteria: The data will be in an encrypted file and will be stored at a secure database in Galway University Hospital. Only the coded data information will be shared.