NCT03299504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
18 days until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

6 months

First QC Date

September 8, 2017

Last Update Submit

August 23, 2018

Conditions

Outcome Measures

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)

    Through study completion, an average of 4 weeks

Secondary Outcomes (4)

  • Gait speed (mph, % expected)

    Through study completion, an average of 4 weeks

  • Single leg stance performance (seconds, % expected)

    Through study completion, an average of 4 weeks

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

    Through study completion, an average of 4 weeks

  • Six minute walk distance (feet, % expected)

    Through study completion, an average of 4 weeks

Other Outcomes (1)

  • Hospital readmission

    6 months

Interventions

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IU Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

Related Publications (7)

  • 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: 27683630BACKGROUND
  • 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: 22390625BACKGROUND
  • 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: 23815281BACKGROUND
  • 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: 23974352BACKGROUND
  • 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: 19839175BACKGROUND
  • 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: 24812254BACKGROUND
  • 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: 23294442BACKGROUND

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dedicated Physical Therapist

Study Record Dates

First Submitted

September 8, 2017

First Posted

October 3, 2017

Study Start

September 26, 2017

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

August 24, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations