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CompletedNCT03299504Updated Aug 24, 2018

Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation

An observational study in Lung Transplant, sponsored by Indiana University Health Methodist Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2018-08-24.

Sponsored by Indiana University Health Methodist Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
105
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.

Read the detailed description

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.

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Conditions studied

  • Lung Transplant
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Lung transplant recipients at IU Health Methodist Hospital. As part of standard care, all patients who survive to hospital discharge are referred by transplant pulmonologists to the COLTT program.

Inclusion criteria

  • All patients who completed the COLTT program from May, 2016 to July, 2017.

Exclusion criteria

Exclusion Criteria:

  • Any COLTT patients who were not new lung transplant recipients.
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
105 participants (actual)
Patient registry
No

Interventions

  • OtherExercise

    5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis

05

What researchers measure

Primary outcomes

  1. Time to reach program goals (days)

    The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)

    Time frame: Through study completion, an average of 4 weeks

Secondary outcomes

  1. Gait speed (mph, % expected)

    Gait speed (walking speed) is measured daily on a oval track

    Time frame: Through study completion, an average of 4 weeks

  2. Single leg stance performance (seconds, % expected)

    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.

    Time frame: Through study completion, an average of 4 weeks

  3. One-minute sit to stand performance (number, % expected)

    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.

    Time frame: Through study completion, an average of 4 weeks

  4. Six minute walk distance (feet, % expected)

    The test result of a six-minute walk test, a field test of exercise capacity

    Time frame: Through study completion, an average of 4 weeks

Other outcomes

  1. Hospital readmission

    Measured as number of hospital readmissions

    Time frame: 6 months

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Study locations

1 site
  • IU Health Methodist Hospital
    Indianapolis, Indiana 46202, United States
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References and documents

Publications

  • 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. PubMed 27683630 ↗
  • 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. PubMed 22390625 ↗
  • 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. PubMed 23815281 ↗
  • 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. PubMed 23974352 ↗
  • 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. PubMed 19839175 ↗
  • 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. PubMed 24812254 ↗
  • 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. PubMed 23294442 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03299504
Lead sponsor
Indiana University Health Methodist Hospital
Responsible party
Christen DiPerna (Dedicated Physical Therapist, Indiana University Health Methodist Hospital) — Principal investigator
First posted
Oct 3, 2017
Start date
Sep 26, 2017
Primary completion
Apr 1, 2018
Completion
Apr 1, 2018
Last update
Aug 24, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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