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Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients (iFRAIL)

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ClinicalTrials.gov Identifier: NCT03636412
Recruitment Status : Recruiting
First Posted : August 17, 2018
Last Update Posted : January 31, 2020
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

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.

Condition or disease Intervention/treatment Phase
Transplant-Related Disorder Frail Elderly Syndrome Sarcopenia Lung Graft Dysfunction Mobility Limitation Other: Ambulation Not Applicable

Detailed Description:

Lung transplant is a lifesaving intervention for patients with advanced lung disease. In addition to this, patients can experience an improved quality of life and reduction in disability post transplant. Despite extensive candidate evaluation and pre-transplant scoring, waitlist mortality remains relatively high, in 2015 at 16.4 per 100 waitlist years and post-transplant 1-year mortality 16.6%.

Frailty is defined as a "generalized vulnerability to stressors" resulting from an accumulation of cognitive and physiologic deficits, which can lead to a significant decline in health following an additional stressor such, i.e. major surgery. Frailty has been associated with delayed graft function and mortality in kidney transplant recipients and waitlist mortality in liver transplant candidates. Components of frailty include weight loss, exhaustion (self-reported), weakness, slow walking speed and low physical activity, however all these components have a complex interplay.

In lung transplant, frailty was also found to be independently associated with patient-reported disability and with subsequent de-listing or death before transplant. There is conflicting evidence regarding the role of pre-transplant frailty on post-transplant outcomes in regards to overall post-operative mortality and hospital length of stay. However, prospective investigations have shown improvements in frailty following lung transplant can lead to improved disability over the first year following lung transplant.

Physical therapy interventions aimed at elderly, frail non-transplant population, were found to be successful at reducing future frailty and mobility related disability. Important components of these regimens include resistance and endurance building exercises to improve maximum oxygen consumption and muscular strength. Identifying at-risk candidates pre- and post-transplant may allow for interventions to improve outcomes. It may also assist in preventing re-admissions, since previous investigations have shown frailty was associated with 30-day hospital re-admissions in patients with after colorectal surgery.

Post-transplant, standard care should include physical activity for patients to help prevent post-operative atelectasis, increase energy, fuel appetite and reduce frailty. In lung transplant patients, exercise following transplantation has been shown to beneficial for muscular strength, six-minute walk distance and self-reported physical functioning. However the reality of care is that physical therapy availability may limit patients from ambulating more than once daily while hospitalized. An improvement in the level of activity available to patients is critical to daily their daily progress after transplant.

The investigators hypothesize that a graded protocol of ambulation which can be implemented by a dedicated patient care nursing assistant (PCNA) multiple times daily will provide significant benefit to patients without the labor and cost requirements of full-time nursing and physical therapy expertise.

The investigators believe this intervention will improve frailty in participants. These benefits will be objectively measured with evaluation of frailty during the pre- and post-transplant period, along with documentation of hospital length of stay, discharge disposition, overall mortality, 30-day readmission rate, and the number of inpatient falls.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 174 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be recruited pre-transplant but on re-evaluation post-transplant based on mobility post-transplant will be enrolled in the ambulatory intervention.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
Actual Study Start Date : August 15, 2018
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ambulatory Intervention
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
An ambulator will walk with a patient three times a day, based on physical therapy recommendations.

No Intervention: No Ambulator
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.



Primary Outcome Measures :
  1. Hospital Length of Stay [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    The duration of time in days for the index admission for the patient beginning immediately after lung transplant

  2. Regular Nursing Floor Length of Stay [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    The duration of time in days a patient stayed on the regular nursing floor following lung transplant

  3. 30-day readmission [ Time Frame: Up to 30 days following discharge ]
    The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission


Secondary Outcome Measures :
  1. Change in physical frailty phenotype [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in physical frailty phenotype pre and post-transplant

  2. Change in short physical performance battery [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in short physical performance battery pre and post-transplant

  3. Change in AMPAC/6-click score [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in AMPAC/6-click score pre and post-transplant

  4. Change in sarcopenia [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in sarcopenia pre and post-transplant (m2)

  5. Change in nutritional status; serum albumin [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in nutritional status; serum albumin pre and post-transplant (g/dL)

  6. Change in nutritional status; serum protein [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in nutritional status; serum protein pre and post-transplant (g/dL)

  7. Change in nutritional status; BMI [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in nutritional status; BMI pre and post-transplant (kg/m2)

  8. Change in eyeball frailty assessment [ Time Frame: pre-transplant to 1 year following transplant ]
    Change in eyeball frailty assessment pre and post-transplant

  9. Presence of aspiration [ Time Frame: pre-transplant to 1 year following transplant ]
    Presence of aspiration pre and post-transplant

  10. Readmission to ICU [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    Readmission to ICU during index hospitalization for lung transplant

  11. In-hospital falls [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    Clinical documentation of a fall during index hospital admission for lung transplant

  12. Aspiration event [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    Presence of clinical aspiration event during index hospital admission for lung transplant

  13. Graft survival [ Time Frame: Through study completion, approximately 1 year post-transplant ]
    Duration of graft functioning from transplant until patient death or re-transplantation

  14. Accelerometer step change [ Time Frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant ]
    Change in steps from pre-transplant to post-transplant

  15. Accelerometer energy expenditure [ Time Frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant ]
    Change in energy expenditure from pre-transplant to post-transplant

  16. Accelerometer time ambulating [ Time Frame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant ]
    Change in time ambulating from pre-transplant to post-transplant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Inclusion Criteria (pre-transplant):

  1. Participant has personally signed and dated informed consent form indicating understanding of all pertinent aspects of the study.
  2. Speaks fluent English
  3. Active on the waiting list for a single or bilateral lung transplant
  4. Able to ambulate pre-transplant (not bed/wheelchair bound) with or without assistive device

Inclusion Criteria (post-transplant)

  1. Have undergone a single or bilateral lung transplant
  2. Admitted to the transplant floor (J82) after discharge from the ICU
  3. Complete history and physical examination on file
  4. 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

Exclusion Criteria (pre-transplant):

  1. Age <18 years
  2. Admitted to hospital for expedited transplant work-up
  3. Admitted to hospital prior to date of transplant
  4. Current invasive mechanical ventilation or placement of ECMO cannula
  5. Multi-organ transplant patients (liver-lung, heart-lung)

Exclusion Criteria (post-transplant)

  1. Bed rest order placed
  2. Requiring invasive mechanical ventilation during the day/night

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03636412


Contacts
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Contact: Marie Budev, DO 216-444-3194 budevm@ccf.org
Contact: Bronwyn Small, MD 216-296-4267 smallb@ccf.org

Locations
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United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Contact: Marie Budev, DO         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Marie Budev, DO The Cleveland Clinic

Publications:

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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03636412    
Other Study ID Numbers: 18-529
First Posted: August 17, 2018    Key Record Dates
Last Update Posted: January 31, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Cleveland Clinic:
lung transplant
frailty
Additional relevant MeSH terms:
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Sarcopenia
Frailty
Mobility Limitation
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms
Pathologic Processes