Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients

NCT03636412 | Completed

• 1 other identifier: 18-529
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital.

Conditions

Transplant-Related Disorder; Frail Elderly Syndrome; Sarcopenia; Lung Graft Dysfunction; Mobility Limitation

Keywords

lung transplant; frailty

Outcome Measures

Primary Outcomes (3)

• Hospital Length of Stay

  The duration of time in days for the index admission for the patient beginning immediately after lung transplant

  Through study completion, approximately 1 year post-transplant

• Regular Nursing Floor Length of Stay

  The duration of time in days a patient stayed on the regular nursing floor following lung transplant

  Through study completion, approximately 1 year post-transplant

• 30-day readmission

  The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission

  Up to 30 days following discharge

Secondary Outcomes (16)

• Change in physical frailty phenotype

  pre-transplant to 1 year following transplant

• Change in short physical performance battery

  pre-transplant to 1 year following transplant

• Change in AMPAC/6-click score

  pre-transplant to 1 year following transplant

• Change in sarcopenia

  pre-transplant to 1 year following transplant

• Change in nutritional status; serum albumin

  pre-transplant to 1 year following transplant

Study Arms (2)

Ambulatory Intervention

EXPERIMENTAL

Patients who score greater than or equal to 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will be enrolled in an ambulatory intervention. Care technicians will ambulate patients three times per day at their level of physical ability. They will also receive physical therapy standard of care.

Other: Ambulation

No Ambulator

NO INTERVENTION

Patients who score less than 6 on the John's Hopkins Highest Level of Mobility (JH-HLM) scale, up to 72 hours after transfer from the ICU to the regular nursing floor will not be enrolled in the ambulatory intervention. They will receive physical therapy standard of care.

Interventions

Ambulation OTHER

An ambulator will walk with a patient three times a day, based on physical therapy recommendations.

Ambulatory Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study.
• Speaks fluent English
• Active on the waiting list for a single or bilateral lung transplant
• Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device
• Have undergone a single or bilateral lung transplant
• Admitted to the transplant floor (J82) after discharge from the ICU
• Complete history and physical examination on file
• Physical therapy consult ordered (standard of care) and JH-HLM Scale of greater than or equal to 6 within 72 hours of transfer to the transplant floor

You may not qualify if:

• Age \<18 years
• Admitted to hospital for expedited transplant work-up
• Admitted to hospital prior to date of transplant
• Current invasive mechanical ventilation or placement of ECMO cannula
• Multi-organ transplant patients (liver-lung, heart-lung)
• Bed rest order placed
• Requiring invasive mechanical ventilation during the day/night

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (20)

• Singer JP, Singer LG. Quality of life in lung transplantation. Semin Respir Crit Care Med. 2013 Jun;34(3):421-30. doi: 10.1055/s-0033-1348470. Epub 2013 Jul 2.

  PMID: 23821515 BACKGROUND

• Valapour M, Skeans MA, Heubner BM, Smith JM, Schnitzler MA, Hertz MI, Edwards LB, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2012 Annual Data Report: lung. Am J Transplant. 2014 Jan;14 Suppl 1:139-65. doi: 10.1111/ajt.12584.

  PMID: 24373171 BACKGROUND

• Yusen RD, Edwards LB, Kucheryavaya AY, Benden C, Dipchand AI, Dobbels F, Goldfarb SB, Levvey BJ, Lund LH, Meiser B, Stehlik J; International Society for Heart and Lung Transplantation. The registry of the International Society for Heart and Lung Transplantation: thirty-first adult lung and heart-lung transplant report--2014; focus theme: retransplantation. J Heart Lung Transplant. 2014 Oct;33(10):1009-24. doi: 10.1016/j.healun.2014.08.004. Epub 2014 Aug 14. No abstract available.

  PMID: 25242125 BACKGROUND

• Valapour M, Skeans MA, Smith JM, Edwards LB, Cherikh WS, Uccellini K, Israni AK, Snyder JJ, Kasiske BL. OPTN/SRTR 2015 Annual Data Report: Lung. Am J Transplant. 2017 Jan;17 Suppl 1:357-424. doi: 10.1111/ajt.14129.

  PMID: 28052607 BACKGROUND

• Singer JP, Diamond JM, Gries CJ, McDonnough J, Blanc PD, Shah R, Dean MY, Hersh B, Wolters PJ, Tokman S, Arcasoy SM, Ramphal K, Greenland JR, Smith N, Heffernan P, Shah L, Shrestha P, Golden JA, Blumenthal NP, Huang D, Sonett J, Hays S, Oyster M, Katz PP, Robbins H, Brown M, Leard LE, Kukreja J, Bacchetta M, Bush E, D'Ovidio F, Rushefski M, Raza K, Christie JD, Lederer DJ. Frailty Phenotypes, Disability, and Outcomes in Adult Candidates for Lung Transplantation. Am J Respir Crit Care Med. 2015 Dec 1;192(11):1325-34. doi: 10.1164/rccm.201506-1150OC.

  PMID: 26258797 BACKGROUND

• Garonzik-Wang JM, Govindan P, Grinnan JW, Liu M, Ali HM, Chakraborty A, Jain V, Ros RL, James NT, Kucirka LM, Hall EC, Berger JC, Montgomery RA, Desai NM, Dagher NN, Sonnenday CJ, Englesbe MJ, Makary MA, Walston JD, Segev DL. Frailty and delayed graft function in kidney transplant recipients. Arch Surg. 2012 Feb;147(2):190-3. doi: 10.1001/archsurg.2011.1229.

  PMID: 22351919 BACKGROUND

• McAdams-DeMarco MA, Law A, King E, Orandi B, Salter M, Gupta N, Chow E, Alachkar N, Desai N, Varadhan R, Walston J, Segev DL. Frailty and mortality in kidney transplant recipients. Am J Transplant. 2015 Jan;15(1):149-54. doi: 10.1111/ajt.12992. Epub 2014 Oct 30.

  PMID: 25359393 BACKGROUND

• Lai JC, Feng S, Terrault NA, Lizaola B, Hayssen H, Covinsky K. Frailty predicts waitlist mortality in liver transplant candidates. Am J Transplant. 2014 Aug;14(8):1870-9. doi: 10.1111/ajt.12762. Epub 2014 Jun 16.

  PMID: 24935609 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• Wilson ME, Vakil AP, Kandel P, Undavalli C, Dunlay SM, Kennedy CC. Pretransplant frailty is associated with decreased survival after lung transplantation. J Heart Lung Transplant. 2016 Feb;35(2):173-8. doi: 10.1016/j.healun.2015.10.014. Epub 2015 Oct 19.

  PMID: 26679297 BACKGROUND

• Singer JP, Lederer DJ, Baldwin MR. Frailty in Pulmonary and Critical Care Medicine. Ann Am Thorac Soc. 2016 Aug;13(8):1394-404. doi: 10.1513/AnnalsATS.201512-833FR.

  PMID: 27104873 BACKGROUND

• Singer JP, Peterson ER, Snyder ME, Katz PP, Golden JA, D'Ovidio F, Bacchetta M, Sonett JR, Kukreja J, Shah L, Robbins H, Van Horn K, Shah RJ, Diamond JM, Wickersham N, Sun L, Hays S, Arcasoy SM, Palmer SM, Ware LB, Christie JD, Lederer DJ. Body composition and mortality after adult lung transplantation in the United States. Am J Respir Crit Care Med. 2014 Nov 1;190(9):1012-21. doi: 10.1164/rccm.201405-0973OC.

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• Jones SE, Maddocks M, Kon SS, Canavan JL, Nolan CM, Clark AL, Polkey MI, Man WD. Sarcopenia in COPD: prevalence, clinical correlates and response to pulmonary rehabilitation. Thorax. 2015 Mar;70(3):213-8. doi: 10.1136/thoraxjnl-2014-206440. Epub 2015 Jan 5.

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• Kelm DJ, Bonnes SL, Jensen MD, Eiken PW, Hathcock MA, Kremers WK, Kennedy CC. Pre-transplant wasting (as measured by muscle index) is a novel prognostic indicator in lung transplantation. Clin Transplant. 2016 Mar;30(3):247-55. doi: 10.1111/ctr.12683. Epub 2016 Feb 11.

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• Cameron ID, Fairhall N, Langron C, Lockwood K, Monaghan N, Aggar C, Sherrington C, Lord SR, Kurrle SE. A multifactorial interdisciplinary intervention reduces frailty in older people: randomized trial. BMC Med. 2013 Mar 11;11:65. doi: 10.1186/1741-7015-11-65.

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• Wickerson L. Exercise training following lung transplant is now evidence-based practice. J Physiother. 2013 Mar;59(1):58. doi: 10.1016/S1836-9553(13)70151-6.

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MeSH Terms

Conditions

Sarcopenia; Mobility Limitation; Frailty

Interventions

Walking

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Marie Budev, DO

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be recruited pre-transplant but on re-evaluation post-transplant based on mobility post-transplant will be enrolled in the ambulatory intervention.

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 17, 2018
• Study Start: August 15, 2018
• Primary Completion: April 15, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)