Lung TransplantNCT03299504
Factors Predicting Success in Lung Transplant Recipients Who Have Undergone Intensive Post-operative Rehabilitation
An observational study of Lung Transplant, run by Indiana University Health Methodist Hospital at 1 site in United States.
Trial summary
This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lung Transplant
- What is being tested?
- Exercise
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2017to 1 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients who completed the COLTT program from May, 2016 to July, 2017.
Who cannot join
- Any COLTT patients who were not new lung transplant recipients.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU Health Methodist Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review
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.
- Conditions
- Lung Transplant
- Being tested
- Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to reach program goals (days)
The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)
Measured: Through study completion, an average of 4 weeks
Secondary outcomes (4)
Gait speed (mph, % expected)
Gait speed (walking speed) is measured daily on a oval track
Measured: Through study completion, an average of 4 weeks
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.
Measured: Through study completion, an average of 4 weeks
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.
Measured: Through study completion, an average of 4 weeks
Six minute walk distance (feet, % expected)
The test result of a six-minute walk test, a field test of exercise capacity
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start26 Sep 2017
- Primary completion1 Apr 2018
- Study completion1 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University Health Methodist Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christen DiPerna, Indiana University Health Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299504
- Sponsor's protocol ID
- RCS1
- Status last verified
- Aug 2018
- First submitted
- 8 Sep 2017
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27683630Langer 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 22390625Walsh 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 23815281Strassmann 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 23974352Springer 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 19839175Middleton 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 24812254Dierich 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
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review
- ClinicalTrials.gov ID
- NCT03299504
- Acronym / sponsor ID
- RCS1
- Conditions
- Lung Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Indiana University Health Methodist HospitalUniversity, hospital or other
- Study start
- 26 Sep 2017 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Apr 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective review of the COLTT program outcomes and factors that predict recovery of functional status after lung transplantation.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All patients who completed the COLTT program from May, 2016 to July, 2017.
Key exclusion criteria (1 listed)
- Any COLTT patients who were not new lung transplant recipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis | Other | – |
Primary outcome
Time to reach program goals (days)
Time frame: Through study completion, an average of 4 weeks
The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)
4 secondary outcomes
Gait speed (mph, % expected)
Time frame: Through study completion, an average of 4 weeks
Single leg stance performance (seconds, % expected)
Time frame: Through study completion, an average of 4 weeks
One-minute sit to stand performance (number, % expected)
Time frame: Through study completion, an average of 4 weeks
Six minute walk distance (feet, % expected)
Time frame: Through study completion, an average of 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Background: PubMed 27683630Wickerson 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.
- Background: PubMed 22390625Langer 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.
- Background: PubMed 23815281Walsh 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.
- Background: PubMed 23974352Strassmann 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.
- Background: PubMed 19839175Springer 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.
- Background: PubMed 24812254Middleton 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.
- Background: PubMed 23294442Dierich 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplant, run by Indiana University Health Methodist Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to reach program goals (days) (time frame: Through study completion, an average of 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299504, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2018.