<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/NCT03043976</url>
  </required_header>
  <id_info>
    <org_study_id>15/LO/1185</org_study_id>
    <nct_id>NCT03043976</nct_id>
  </id_info>
  <brief_title>Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension</brief_title>
  <acronym>STEPinPH</acronym>
  <official_title>Using Step Count to Enhance Daily Physical Activity in Pulmonary Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Imperial College Healthcare NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Imperial College Healthcare NHS Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will collect information about physical activity in patients affected by pulmonary&#xD;
      hypertension, through a specific device that can be worn on the wrist, and which measures&#xD;
      daily step count. The purpose of the study is to demonstrate whether providing patients with&#xD;
      their daily step count can increase their levels of daily activity if they have some basic&#xD;
      targets to achieve. Investigators also wish to compare the effects of this approach in&#xD;
      increasing daily physical activity, with the benefit gained when a drug therapy for pulmonary&#xD;
      hypertension is initiated, in patients that have just been diagnosed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pulmonary hypertension (PH) is a rare and progressive disorder and shortness of breath and&#xD;
      fatigue, especially during exercise, are very common symptoms, resulting in a reduced&#xD;
      capacity to perform daily activities and in an impaired quality of life. Furthermore, reduced&#xD;
      exercise capacity in PH is associated with depression and anxiety disorders. Recent&#xD;
      literature reveals a strong association of sedentary time with adverse cardiovascular&#xD;
      outcomes, so that the development of therapeutic strategies to avoid this event is pivotal in&#xD;
      the management of PH, in addition to the beneficial results of modern medical treatment.&#xD;
      Recently the role of exercise and rehabilitation in different respiratory and cardiac&#xD;
      conditions has been evaluated in the literature, overtaking the concerns raised in the past&#xD;
      that exercise could worsen the condition and thus the progression of these kind of diseases,&#xD;
      but just a few studies have been done in patients affected by PH.&#xD;
&#xD;
      International guidelines on pulmonary hypertension recommend avoiding strenuous exercise that&#xD;
      leads to distressing symptoms, while encourage low level graded aerobic exercise, such as&#xD;
      walking, as tolerated. Nonetheless, little is still known about the effects of lifestyle&#xD;
      changes, such as the amount of physical activity that patients can or should practice.&#xD;
      Pedometers have been used to enhance the daily physical activity and to improve, when&#xD;
      assessed, some prognosis related outcomes, both in healthy subjects and those affected by&#xD;
      different pathological conditions, in particular cardiac and respiratory diseases. However, a&#xD;
      training model based on step count targets has never been evaluated in PH, to our knowledge.&#xD;
      Step counting devices have recently experienced a surge in popularity as a tool for&#xD;
      motivating and monitoring physical activity in the general population, especially combined&#xD;
      with applications for smartphones, that provide feedback, such as an overview of the data&#xD;
      recorded. Thus, it seems reasonable to explore the opportunity to develop a step count based&#xD;
      training model to enhance daily exercise in PH patients, through these non-invasive, patient&#xD;
      friendly and relatively inexpensive devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study terminated early due to ligistic reasons with study staff&#xD;
  </why_stopped>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Crossover Assignment</intervention_model>
    <intervention_model_description>Partial crossover. A group of 10 underwent the intervention, a group of 10 was observed for 8 weeks without receiveng any feedback, then underwent the intervention. The main outcome was evaluated as the difference between the end of intervention and baseline (paired data). We did not recuit any patient in arm 3.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in daily physical activity</measure>
    <time_frame>From baseline to 16 - 25 weeks</time_frame>
    <description>The principal objective is to demonstrate a difference in the intensity of daily physical activity, measured in activity counts per minute, from the basal period to the last week of the 8-week training programme compared with control</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 6MWT</measure>
    <time_frame>From baseline to 16 - 25 weeks</time_frame>
    <description>Evaluation of the difference in the 6MWT from the basal period to the end of the 8-week training programme compared with control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in BNP</measure>
    <time_frame>From baseline to 16 - 25 weeks</time_frame>
    <description>Evaluation of the difference in BNP values from the basal period to the end of the 8-week training programme compared with control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>From baseline to 16 - 25 weeks</time_frame>
    <description>Evaluation of the difference in quality of life (assessed by SF36 questionnaire) from the basal period to the end of the 8-week training programme compared with control</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Long-term effects of training protocol</measure>
    <time_frame>End of the 8 week period</time_frame>
    <description>Evaluate if the eventual benefit gained after the 8 week training period (measured in activity counts per minute) is maintained, reduced or increased for a further 8 week period (group1+ group 2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison between training protocol and initiation of PH treatment in terms of increased physical activity</measure>
    <time_frame>5-6 weeks</time_frame>
    <description>Comparing the efficacy of our training protocol to the effects of the initiation of the PH drug treatment in newly diagnosed patients, in terms of increased physical activity assessed in terms of activity counts.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Hypertension, Pulmonary</condition>
  <arm_group>
    <arm_group_label>feedback and goal-setting group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'walk test (6MWT), will undertake a blood sample (BNP). In the run-in period (1 week) patients will wear an Actigraph GT9X Link device which only displays the time and the battery level; all activity data will be recorded. Then participants will wear an Actigraph GT9X Link device which shows real time data about the number of steps and will upload their data via the Study Admin Mobile application for smartphones/tablets. Patients will be asked to aim for an average specified number of steps/day week by week and will receive a weekly report with results from the previous week and targets to achieve. After 8 weeks, patients will attend visit 2 (6MWT, SF36 and BNP assessment) and will carry on wearing the activated device for 8 weeks receiving weekly feedbacks and targets. After 8 weeks patients will attend visit 3 (6MWD, SF36 and BNP will be assessed) which is the end of the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'WT and will undertake a blood sample (BNP). After a run-in period (1 week) with an Actigraph GT9X Link device disabled from showing the number of steps, patients will wear an Actigraph GT9X Link device which still only displays time and battery level and will upload data via the Study Admin Mobile application for smartphones/tablets without receiving any feedback. After 8 weeks, patients will be assessed (SF36, 6'WT, BNP) and will start to wear a new device enabled to display the daily step count. Patients will be asked to aim for an average specified number of steps/day, receiving a weekly summary of the previous week with targets to achieve week by week. After 8 weeks, patients will be assessed (6'WT, SF36, BNP) and will carry on wearing the device and receiving feedbacks and targets for a further 8 week period, after that patients will be finally assessed (SF36, 6'WT, BNP)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>newly diagnosed patients</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the week leading up to their inpatient admission for diagnostic investigations, patients who are treatment-naïve will be given the Actigraph GT9X Link device which will only display the time and the charge level of the battery. Patients will be asked, as well, to fill a questionnaire about their quality of life, to perform a 6MWT and a blood sample (BNP). As soon as patients start the drug therapy, patients will wear a second Actigraph GT9X Link device still disabled from showing real time data about the number of daily steps. Participants will not receive any feedback during the whole period and will be asked, as well, to upload the data collected through the remote mobile system. At their first clinical assessment (after about 4 or 5 weeks), 6'WT, BNP and questionnaire about quality of life will be reassessed.&#xD;
If patients are not being started on drug therapy then they will be withdrawn from the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Actigraph GT9X Link device</intervention_name>
    <description>Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer.&#xD;
Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>feedback and goal-setting group</arm_group_label>
    <arm_group_label>newly diagnosed patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
          -  Nice Classification Groups 1 and 4 Pulmonary Hypertension (pulmonary arterial&#xD;
             hypertension and chronic thromboembolic pulmonary hypertension)&#xD;
&#xD;
          -  WHO functional class I-IV&#xD;
&#xD;
          -  Stable on current medication for 8/52 for group 1 (feedback and goal-setting group)&#xD;
             and group 2 (control group)&#xD;
&#xD;
          -  For group 3 (newly diagnosed patients), treatment-naïve patients undergoing&#xD;
             investigation who are likely to start therapy (based on clinical judgment of the&#xD;
             clinician)&#xD;
&#xD;
          -  Patients with handheld devices (such as smartphones or tablets) which can run the&#xD;
             Study Admin Mobile application.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy: we will screen for this on the basis of the history from the patient, and&#xD;
             if she is not sure if she might be pregnant, a pregnancy test will be offered&#xD;
&#xD;
          -  Malignant arrhythmias&#xD;
&#xD;
          -  Syncope within the last 6 months&#xD;
&#xD;
          -  Skeletal or muscle abnormalities prohibiting walking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luke SGE Howard</last_name>
    <role>Principal Investigator</role>
    <affiliation>Imperial College Healthcare NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hammersmith Hospital</name>
      <address>
        <city>London</city>
        <zip>W12 0HS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Grunig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.</citation>
    <PMID>22323570</PMID>
  </reference>
  <reference>
    <citation>Mainguy V, Provencher S, Maltais F, Malenfant S, Saey D. Assessment of daily life physical activities in pulmonary arterial hypertension. PLoS One. 2011;6(11):e27993. doi: 10.1371/journal.pone.0027993. Epub 2011 Nov 16.</citation>
    <PMID>22110770</PMID>
  </reference>
  <reference>
    <citation>de Man FS, Handoko ML, Groepenhoff H, van 't Hul AJ, Abbink J, Koppers RJ, Grotjohan HP, Twisk JW, Bogaard HJ, Boonstra A, Postmus PE, Westerhof N, van der Laarse WJ, Vonk-Noordegraaf A. Effects of exercise training in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2009 Sep;34(3):669-75. doi: 10.1183/09031936.00027909.</citation>
    <PMID>19720810</PMID>
  </reference>
  <reference>
    <citation>Mendoza L, Horta P, Espinoza J, Aguilera M, Balmaceda N, Castro A, Ruiz M, Diaz O, Hopkinson NS. Pedometers to enhance physical activity in COPD: a randomised controlled trial. Eur Respir J. 2015 Feb;45(2):347-54. doi: 10.1183/09031936.00084514. Epub 2014 Sep 26.</citation>
    <PMID>25261324</PMID>
  </reference>
  <reference>
    <citation>McLaughlin VV, Archer SL, Badesch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J, Harrington RA, Anderson JL, Bates ER, Bridges CR, Eisenberg MJ, Ferrari VA, Grines CL, Hlatky MA, Jacobs AK, Kaul S, Lichtenberg RC, Lindner JR, Moliterno DJ, Mukherjee D, Pohost GM, Rosenson RS, Schofield RS, Shubrooks SJ, Stein JH, Tracy CM, Weitz HH, Wesley DJ; ACCF/AHA. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009 Apr 28;119(16):2250-94. doi: 10.1161/CIRCULATIONAHA.109.192230. Epub 2009 Mar 30. No abstract available. Erratum In: Circulation. 2009 Jul 14;120(2):e13.</citation>
    <PMID>19332472</PMID>
  </reference>
  <reference>
    <citation>Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.</citation>
    <PMID>16982941</PMID>
  </reference>
  <reference>
    <citation>Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.</citation>
    <PMID>22576635</PMID>
  </reference>
  <reference>
    <citation>Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. No abstract available. Erratum In: Eur Heart J. 2011 Apr;32(8):926.</citation>
    <PMID>19713419</PMID>
  </reference>
  <reference>
    <citation>Ulrich S, Fischler M, Speich R, Bloch KE. Wrist actigraphy predicts outcome in patients with pulmonary hypertension. Respiration. 2013;86(1):45-51. doi: 10.1159/000342351. Epub 2012 Dec 11.</citation>
    <PMID>23234873</PMID>
  </reference>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 9, 2016</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>July 10, 2019</last_update_submitted>
  <last_update_submitted_qc>July 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Physical activity</keyword>
  <keyword>Steps count</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension, Pulmonary</mesh_term>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT03043976
org study id: 15/LO/1185
nct id: NCT03043976
lead sponsor: 
has dmc: No
This study will collect information about physical activity in patients affected by pulmonary
      hypertension, through a specific device that can be worn on the wrist, and which measures
      daily step count. The purpose of the study is to demonstrate whether providing patients with
      their daily step count can increase their levels of daily activity if they have some basic
      targets to achieve. Investigators also wish to compare the effects of this approach in
      increasing daily physical activity, with the benefit gained when a drug therapy for pulmonary
      hypertension is initiated, in patients that have just been diagnosed.
Pulmonary hypertension (PH) is a rare and progressive disorder and shortness of breath and
      fatigue, especially during exercise, are very common symptoms, resulting in a reduced
      capacity to perform daily activities and in an impaired quality of life. Furthermore, reduced
      exercise capacity in PH is associated with depression and anxiety disorders. Recent
      literature reveals a strong association of sedentary time with adverse cardiovascular
      outcomes, so that the development of therapeutic strategies to avoid this event is pivotal in
      the management of PH, in addition to the beneficial results of modern medical treatment.
      Recently the role of exercise and rehabilitation in different respiratory and cardiac
      conditions has been evaluated in the literature, overtaking the concerns raised in the past
      that exercise could worsen the condition and thus the progression of these kind of diseases,
      but just a few studies have been done in patients affected by PH.

      International guidelines on pulmonary hypertension recommend avoiding strenuous exercise that
      leads to distressing symptoms, while encourage low level graded aerobic exercise, such as
      walking, as tolerated. Nonetheless, little is still known about the effects of lifestyle
      changes, such as the amount of physical activity that patients can or should practice.
      Pedometers have been used to enhance the daily physical activity and to improve, when
      assessed, some prognosis related outcomes, both in healthy subjects and those affected by
      different pathological conditions, in particular cardiac and respiratory diseases. However, a
      training model based on step count targets has never been evaluated in PH, to our knowledge.
      Step counting devices have recently experienced a surge in popularity as a tool for
      motivating and monitoring physical activity in the general population, especially combined
      with applications for smartphones, that provide feedback, such as an overview of the data
      recorded. Thus, it seems reasonable to explore the opportunity to develop a step count based
      training model to enhance daily exercise in PH patients, through these non-invasive, patient
      friendly and relatively inexpensive devices.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Partial crossover. A group of 10 underwent the intervention, a group of 10 was observed for 8 weeks without receiveng any feedback, then underwent the intervention. The main outcome was evaluated as the difference between the end of intervention and baseline (paired data). We did not recuit any patient in arm 3.
primary purpose: Treatment
masking: None (Open Label)
measure: Change in daily physical activity
time frame: From baseline to 16 - 25 weeks
description: The principal objective is to demonstrate a difference in the intensity of daily physical activity, measured in activity counts per minute, from the basal period to the last week of the 8-week training programme compared with control
measure: Change in 6MWT
time frame: From baseline to 16 - 25 weeks
description: Evaluation of the difference in the 6MWT from the basal period to the end of the 8-week training programme compared with control
measure: Change in BNP
time frame: From baseline to 16 - 25 weeks
description: Evaluation of the difference in BNP values from the basal period to the end of the 8-week training programme compared with control
measure: Change in Quality of life
time frame: From baseline to 16 - 25 weeks
description: Evaluation of the difference in quality of life (assessed by SF36 questionnaire) from the basal period to the end of the 8-week training programme compared with control
measure: Long-term effects of training protocol
time frame: End of the 8 week period
description: Evaluate if the eventual benefit gained after the 8 week training period (measured in activity counts per minute) is maintained, reduced or increased for a further 8 week period (group1+ group 2).
measure: Comparison between training protocol and initiation of PH treatment in terms of increased physical activity
time frame: 5-6 weeks
description: Comparing the efficacy of our training protocol to the effects of the initiation of the PH drug treatment in newly diagnosed patients, in terms of increased physical activity assessed in terms of activity counts.
arm group label: feedback and goal-setting group
arm group type: Active Comparator
description: At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'walk test (6MWT), will undertake a blood sample (BNP). In the run-in period (1 week) patients will wear an Actigraph GT9X Link device which only displays the time and the battery level; all activity data will be recorded. Then participants will wear an Actigraph GT9X Link device which shows real time data about the number of steps and will upload their data via the Study Admin Mobile application for smartphones/tablets. Patients will be asked to aim for an average specified number of steps/day week by week and will receive a weekly report with results from the previous week and targets to achieve. After 8 weeks, patients will attend visit 2 (6MWT, SF36 and BNP assessment) and will carry on wearing the activated device for 8 weeks receiving weekly feedbacks and targets. After 8 weeks patients will attend visit 3 (6MWD, SF36 and BNP will be assessed) which is the end of the study.
arm group label: Control group
arm group type: Active Comparator
description: At the baseline, patients will fill a questionnaire about their quality of life (SF36), will perform a 6'WT and will undertake a blood sample (BNP). After a run-in period (1 week) with an Actigraph GT9X Link device disabled from showing the number of steps, patients will wear an Actigraph GT9X Link device which still only displays time and battery level and will upload data via the Study Admin Mobile application for smartphones/tablets without receiving any feedback. After 8 weeks, patients will be assessed (SF36, 6'WT, BNP) and will start to wear a new device enabled to display the daily step count. Patients will be asked to aim for an average specified number of steps/day, receiving a weekly summary of the previous week with targets to achieve week by week. After 8 weeks, patients will be assessed (6'WT, SF36, BNP) and will carry on wearing the device and receiving feedbacks and targets for a further 8 week period, after that patients will be finally assessed (SF36, 6'WT, BNP)
arm group label: newly diagnosed patients
arm group type: Placebo Comparator
description: In the week leading up to their inpatient admission for diagnostic investigations, patients who are treatment-naïve will be given the Actigraph GT9X Link device which will only display the time and the charge level of the battery. Patients will be asked, as well, to fill a questionnaire about their quality of life, to perform a 6MWT and a blood sample (BNP). As soon as patients start the drug therapy, patients will wear a second Actigraph GT9X Link device still disabled from showing real time data about the number of daily steps. Participants will not receive any feedback during the whole period and will be asked, as well, to upload the data collected through the remote mobile system. At their first clinical assessment (after about 4 or 5 weeks), 6'WT, BNP and questionnaire about quality of life will be reassessed.
If patients are not being started on drug therapy then they will be withdrawn from the study
intervention type: Device
intervention name: Actigraph GT9X Link device
description: Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer.
Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased
arm group label: Control group
arm group label: feedback and goal-setting group
arm group label: newly diagnosed patients
criteria: 
gender: All
minimum age: 19 Years
maximum age: 90 Years
healthy volunteers: No
last name: Luke SGE Howard
role: Principal Investigator
affiliation: Imperial College Healthcare NHS Trust
facility: 
country: United Kingdom
citation: Grunig E, Lichtblau M, Ehlken N, Ghofrani HA, Reichenberger F, Staehler G, Halank M, Fischer C, Seyfarth HJ, Klose H, Meyer A, Sorichter S, Wilkens H, Rosenkranz S, Opitz C, Leuchte H, Karger G, Speich R, Nagel C. Safety and efficacy of exercise training in various forms of pulmonary hypertension. Eur Respir J. 2012 Jul;40(1):84-92. doi: 10.1183/09031936.00123711. Epub 2012 Feb 9.
PMID: 22323570
citation: Mainguy V, Provencher S, Maltais F, Malenfant S, Saey D. Assessment of daily life physical activities in pulmonary arterial hypertension. PLoS One. 2011;6(11):e27993. doi: 10.1371/journal.pone.0027993. Epub 2011 Nov 16.
PMID: 22110770
citation: de Man FS, Handoko ML, Groepenhoff H, van 't Hul AJ, Abbink J, Koppers RJ, Grotjohan HP, Twisk JW, Bogaard HJ, Boonstra A, Postmus PE, Westerhof N, van der Laarse WJ, Vonk-Noordegraaf A. Effects of exercise training in patients with idiopathic pulmonary arterial hypertension. Eur Respir J. 2009 Sep;34(3):669-75. doi: 10.1183/09031936.00027909.
PMID: 19720810
citation: Mendoza L, Horta P, Espinoza J, Aguilera M, Balmaceda N, Castro A, Ruiz M, Diaz O, Hopkinson NS. Pedometers to enhance physical activity in COPD: a randomised controlled trial. Eur Respir J. 2015 Feb;45(2):347-54. doi: 10.1183/09031936.00084514. Epub 2014 Sep 26.
PMID: 25261324
citation: McLaughlin VV, Archer SL, Badesch DB, Barst RJ, Farber HW, Lindner JR, Mathier MA, McGoon MD, Park MH, Rosenson RS, Rubin LJ, Tapson VF, Varga J, Harrington RA, Anderson JL, Bates ER, Bridges CR, Eisenberg MJ, Ferrari VA, Grines CL, Hlatky MA, Jacobs AK, Kaul S, Lichtenberg RC, Lindner JR, Moliterno DJ, Mukherjee D, Pohost GM, Rosenson RS, Schofield RS, Shubrooks SJ, Stein JH, Tracy CM, Weitz HH, Wesley DJ; ACCF/AHA. ACCF/AHA 2009 expert consensus document on pulmonary hypertension: a report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents and the American Heart Association: developed in collaboration with the American College of Chest Physicians, American Thoracic Society, Inc., and the Pulmonary Hypertension Association. Circulation. 2009 Apr 28;119(16):2250-94. doi: 10.1161/CIRCULATIONAHA.109.192230. Epub 2009 Mar 30. No abstract available. Erratum In: Circulation. 2009 Jul 14;120(2):e13.
PMID: 19332472
citation: Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
PMID: 16982941
citation: Pugh ME, Buchowski MS, Robbins IM, Newman JH, Hemnes AR. Physical activity limitation as measured by accelerometry in pulmonary arterial hypertension. Chest. 2012 Dec;142(6):1391-1398. doi: 10.1378/chest.12-0150.
PMID: 22576635
citation: Galie N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G; ESC Committee for Practice Guidelines (CPG). Guidelines for the diagnosis and treatment of pulmonary hypertension: the Task Force for the Diagnosis and Treatment of Pulmonary Hypertension of the European Society of Cardiology (ESC) and the European Respiratory Society (ERS), endorsed by the International Society of Heart and Lung Transplantation (ISHLT). Eur Heart J. 2009 Oct;30(20):2493-537. doi: 10.1093/eurheartj/ehp297. Epub 2009 Aug 27. No abstract available. Erratum In: Eur Heart J. 2011 Apr;32(8):926.
PMID: 19713419
citation: Ulrich S, Fischler M, Speich R, Bloch KE. Wrist actigraphy predicts outcome in patients with pulmonary hypertension. Respiration. 2013;86(1):45-51. doi: 10.1159/000342351. Epub 2012 Dec 11.
PMID: 23234873
responsible party type: Sponsor
mesh term: Hypertension, Pulmonary
mesh term: Hypertension