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

Lung Transplant Clinical Trial

Official title:

Factors Predicting Success in Lung Transplant Recipients Who Have Participated in the COLTT Program (Daily Intensive Post-hospitalization Rehabilitation): A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03299504
• Other study ID #: RCS1
• Status: Completed
• Start date: September 26, 2017
• Est. completion date: April 1, 2018

Study information

• Verified date: August 2018
• Source: Indiana University Health Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: April 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Lung Transplant

Intervention

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

Locations

Country	Name	City	State
United States	IU Health Methodist Hospital	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University Health Methodist Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. Review. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hospital readmission	Measured as number of hospital readmissions	6 months
Primary	Time to reach program goals (days)	The number of days in the COLTT program required to reach program goals ( see secondary outcomes measures)	Through study completion, an average of 4 weeks
Secondary	Gait speed (mph, % expected)	Gait speed (walking speed) is measured daily on a oval track	Through study completion, an average of 4 weeks
Secondary	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.	Through study completion, an average of 4 weeks
Secondary	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.	Through study completion, an average of 4 weeks
Secondary	Six minute walk distance (feet, % expected)	The test result of a six-minute walk test, a field test of exercise capacity	Through study completion, an average of 4 weeks