<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/NCT03299504</url>
  </required_header>
  <id_info>
    <org_study_id>RCS1</org_study_id>
    <nct_id>NCT03299504</nct_id>
  </id_info>
  <brief_title>Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation</brief_title>
  <official_title>Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University Health Methodist Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University Health Methodist 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 is a retrospective review of the COLTT program outcomes and factors that predict&#xD;
      recovery of functional status after lung transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week)&#xD;
      intensive rehabilitation program for patients who have undergone lung transplant. Patients&#xD;
      are enrolled in COLTT as part of standard care after hospital discharge. This study is a&#xD;
      retrospective review of seventy patients that measures the efficacy of the COLTT program and&#xD;
      establishes predictors of patient success.This study will also measure the effect of&#xD;
      functional outcomes on hospital readmission post COLTT discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to reach program goals (days)</measure>
    <time_frame>Through study completion, an average of 4 weeks</time_frame>
    <description>The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gait speed (mph, % expected)</measure>
    <time_frame>Through study completion, an average of 4 weeks</time_frame>
    <description>Gait speed (walking speed) is measured daily on a oval track</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Single leg stance performance (seconds, % expected)</measure>
    <time_frame>Through study completion, an average of 4 weeks</time_frame>
    <description>The test result of a single leg stance test. Patients stand with hands on their hips, raise one leg off the ground and hold it for as long as possible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>One-minute sit to stand performance (number, % expected)</measure>
    <time_frame>Through study completion, an average of 4 weeks</time_frame>
    <description>The test result of a one-minute sit to stand test. Patients stand/sit from a chair as many times as they can in one minute.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Six minute walk distance (feet, % expected)</measure>
    <time_frame>Through study completion, an average of 4 weeks</time_frame>
    <description>The test result of a six-minute walk test, a field test of exercise capacity</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hospital readmission</measure>
    <time_frame>6 months</time_frame>
    <description>Measured as number of hospital readmissions</description>
  </other_outcome>
  <enrollment type="Actual">105</enrollment>
  <condition>Lung Transplant</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Lung transplant recipients at IU Health Methodist Hospital. As part of standard care, all&#xD;
        patients who survive to hospital discharge are referred by transplant pulmonologists to the&#xD;
        COLTT program.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients who completed the COLTT program from May, 2016 to July, 2017.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any COLTT patients who were not new lung transplant recipients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>IU Health Methodist Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Wickerson L, Rozenberg D, Janaudis-Ferreira T, Deliva R, Lo V, Beauchamp G, Helm D, Gottesman C, Mendes P, Vieira L, Herridge M, Singer LG, Mathur S. Physical rehabilitation for lung transplant candidates and recipients: An evidence-informed clinical approach. World J Transplant. 2016 Sep 24;6(3):517-31. doi: 10.5500/wjt.v6.i3.517.</citation>
    <PMID>27683630</PMID>
  </reference>
  <reference>
    <citation>Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.</citation>
    <PMID>22390625</PMID>
  </reference>
  <reference>
    <citation>Walsh JR, Chambers DC, Davis RJ, Morris NR, Seale HE, Yerkovich ST, Hopkins PM. Impaired exercise capacity after lung transplantation is related to delayed recovery of muscle strength. Clin Transplant. 2013 Jul-Aug;27(4):E504-11. doi: 10.1111/ctr.12163. Epub 2013 Jul 2.</citation>
    <PMID>23815281</PMID>
  </reference>
  <reference>
    <citation>Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.</citation>
    <PMID>23974352</PMID>
  </reference>
  <reference>
    <citation>Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.</citation>
    <PMID>19839175</PMID>
  </reference>
  <reference>
    <citation>Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.</citation>
    <PMID>24812254</PMID>
  </reference>
  <reference>
    <citation>Dierich M, Tecklenburg A, Fuehner T, Tegtbur U, Welte T, Haverich A, Warnecke G, Gottlieb J. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. doi: 10.1111/tri.12048. Epub 2013 Jan 7.</citation>
    <PMID>23294442</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>August 23, 2018</last_update_submitted>
  <last_update_submitted_qc>August 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University Health Methodist Hospital</investigator_affiliation>
    <investigator_full_name>Christen DiPerna</investigator_full_name>
    <investigator_title>Dedicated Physical Therapist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03299504
org study id: RCS1
nct id: NCT03299504
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a retrospective review of the COLTT program outcomes and factors that predict
      recovery of functional status after lung transplantation.
The Center of Life for Thoracic Transplant (COLTT) program is a daily (5 days per week)
      intensive rehabilitation program for patients who have undergone lung transplant. Patients
      are enrolled in COLTT as part of standard care after hospital discharge. This study is a
      retrospective review of seventy patients that measures the efficacy of the COLTT program and
      establishes predictors of patient success.This study will also measure the effect of
      functional outcomes on hospital readmission post COLTT discharge.
observational model: Cohort
time perspective: Retrospective
measure: Time to reach program goals (days)
time frame: Through study completion, an average of 4 weeks
description: The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)
measure: Gait speed (mph, % expected)
time frame: Through study completion, an average of 4 weeks
description: Gait speed (walking speed) is measured daily on a oval track
measure: Single leg stance performance (seconds, % expected)
time frame: Through study completion, an average of 4 weeks
description: The test result of a single leg stance test. Patients stand with hands on their hips, raise one leg off the ground and hold it for as long as possible.
measure: One-minute sit to stand performance (number, % expected)
time frame: Through study completion, an average of 4 weeks
description: The test result of a one-minute sit to stand test. Patients stand/sit from a chair as many times as they can in one minute.
measure: Six minute walk distance (feet, % expected)
time frame: Through study completion, an average of 4 weeks
description: The test result of a six-minute walk test, a field test of exercise capacity
measure: Hospital readmission
time frame: 6 months
description: Measured as number of hospital readmissions
intervention type: Other
intervention name: Exercise
description: 5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: United States
citation: Wickerson L, Rozenberg D, Janaudis-Ferreira T, Deliva R, Lo V, Beauchamp G, Helm D, Gottesman C, Mendes P, Vieira L, Herridge M, Singer LG, Mathur S. Physical rehabilitation for lung transplant candidates and recipients: An evidence-informed clinical approach. World J Transplant. 2016 Sep 24;6(3):517-31. doi: 10.5500/wjt.v6.i3.517.
PMID: 27683630
citation: Langer D, Burtin C, Schepers L, Ivanova A, Verleden G, Decramer M, Troosters T, Gosselink R. Exercise training after lung transplantation improves participation in daily activity: a randomized controlled trial. Am J Transplant. 2012 Jun;12(6):1584-92. doi: 10.1111/j.1600-6143.2012.04000.x. Epub 2012 Mar 5.
PMID: 22390625
citation: Walsh JR, Chambers DC, Davis RJ, Morris NR, Seale HE, Yerkovich ST, Hopkins PM. Impaired exercise capacity after lung transplantation is related to delayed recovery of muscle strength. Clin Transplant. 2013 Jul-Aug;27(4):E504-11. doi: 10.1111/ctr.12163. Epub 2013 Jul 2.
PMID: 23815281
citation: Strassmann A, Steurer-Stey C, Lana KD, Zoller M, Turk AJ, Suter P, Puhan MA. Population-based reference values for the 1-min sit-to-stand test. Int J Public Health. 2013 Dec;58(6):949-53. doi: 10.1007/s00038-013-0504-z. Epub 2013 Aug 24.
PMID: 23974352
citation: Springer BA, Marin R, Cyhan T, Roberts H, Gill NW. Normative values for the unipedal stance test with eyes open and closed. J Geriatr Phys Ther. 2007;30(1):8-15. doi: 10.1519/00139143-200704000-00003.
PMID: 19839175
citation: Middleton A, Fritz SL, Lusardi M. Walking speed: the functional vital sign. J Aging Phys Act. 2015 Apr;23(2):314-22. doi: 10.1123/japa.2013-0236. Epub 2014 May 2.
PMID: 24812254
citation: Dierich M, Tecklenburg A, Fuehner T, Tegtbur U, Welte T, Haverich A, Warnecke G, Gottlieb J. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. doi: 10.1111/tri.12048. Epub 2013 Jan 7.
PMID: 23294442
responsible party type: Principal Investigator
investigator affiliation: Indiana University Health Methodist Hospital
investigator full name: Christen DiPerna
investigator title: Dedicated Physical Therapist
sharing ipd: No