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

Primary Purpose

Transplant-Related Disorder, Frail Elderly Syndrome, Sarcopenia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ambulation
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Transplant-Related Disorder focused on measuring lung transplant, frailty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Ambulatory Intervention

No Ambulator

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Length of Stay
The duration of time in days for the index admission for the patient beginning immediately after lung transplant
Regular Nursing Floor Length of Stay
The duration of time in days a patient stayed on the regular nursing floor following lung transplant
30-day readmission
The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission

Secondary Outcome Measures

Change in physical frailty phenotype
Change in physical frailty phenotype pre and post-transplant
Change in short physical performance battery
Change in short physical performance battery pre and post-transplant
Change in AMPAC/6-click score
Change in AMPAC/6-click score pre and post-transplant
Change in sarcopenia
Change in sarcopenia pre and post-transplant (m2)
Change in nutritional status; serum albumin
Change in nutritional status; serum albumin pre and post-transplant (g/dL)
Change in nutritional status; serum protein
Change in nutritional status; serum protein pre and post-transplant (g/dL)
Change in nutritional status; BMI
Change in nutritional status; BMI pre and post-transplant (kg/m2)
Change in eyeball frailty assessment
Change in eyeball frailty assessment pre and post-transplant
Presence of aspiration
Presence of aspiration pre and post-transplant
Readmission to ICU
Readmission to ICU during index hospitalization for lung transplant
In-hospital falls
Clinical documentation of a fall during index hospital admission for lung transplant
Aspiration event
Presence of clinical aspiration event during index hospital admission for lung transplant
Graft survival
Duration of graft functioning from transplant until patient death or re-transplantation
Accelerometer step change
Change in steps from pre-transplant to post-transplant
Accelerometer energy expenditure
Change in energy expenditure from pre-transplant to post-transplant
Accelerometer time ambulating
Change in time ambulating from pre-transplant to post-transplant

Full Information

First Posted
August 13, 2018
Last Updated
August 10, 2023
Sponsor
The Cleveland Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03636412
Brief Title
Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
Acronym
iFRAIL
Official Title
Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant-Related Disorder, Frail Elderly Syndrome, Sarcopenia, Lung Graft Dysfunction, Mobility Limitation
Keywords
lung transplant, frailty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambulatory Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
No Ambulator
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Ambulation
Intervention Description
An ambulator will walk with a patient three times a day, based on physical therapy recommendations.
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
The duration of time in days for the index admission for the patient beginning immediately after lung transplant
Time Frame
Through study completion, approximately 1 year post-transplant
Title
Regular Nursing Floor Length of Stay
Description
The duration of time in days a patient stayed on the regular nursing floor following lung transplant
Time Frame
Through study completion, approximately 1 year post-transplant
Title
30-day readmission
Description
The incidence of readmission to hospital within 30 days of patient discharge from hospital after index lung transplant admission
Time Frame
Up to 30 days following discharge
Secondary Outcome Measure Information:
Title
Change in physical frailty phenotype
Description
Change in physical frailty phenotype pre and post-transplant
Time Frame
pre-transplant to 1 year following transplant
Title
Change in short physical performance battery
Description
Change in short physical performance battery pre and post-transplant
Time Frame
pre-transplant to 1 year following transplant
Title
Change in AMPAC/6-click score
Description
Change in AMPAC/6-click score pre and post-transplant
Time Frame
pre-transplant to 1 year following transplant
Title
Change in sarcopenia
Description
Change in sarcopenia pre and post-transplant (m2)
Time Frame
pre-transplant to 1 year following transplant
Title
Change in nutritional status; serum albumin
Description
Change in nutritional status; serum albumin pre and post-transplant (g/dL)
Time Frame
pre-transplant to 1 year following transplant
Title
Change in nutritional status; serum protein
Description
Change in nutritional status; serum protein pre and post-transplant (g/dL)
Time Frame
pre-transplant to 1 year following transplant
Title
Change in nutritional status; BMI
Description
Change in nutritional status; BMI pre and post-transplant (kg/m2)
Time Frame
pre-transplant to 1 year following transplant
Title
Change in eyeball frailty assessment
Description
Change in eyeball frailty assessment pre and post-transplant
Time Frame
pre-transplant to 1 year following transplant
Title
Presence of aspiration
Description
Presence of aspiration pre and post-transplant
Time Frame
pre-transplant to 1 year following transplant
Title
Readmission to ICU
Description
Readmission to ICU during index hospitalization for lung transplant
Time Frame
Through study completion, approximately 1 year post-transplant
Title
In-hospital falls
Description
Clinical documentation of a fall during index hospital admission for lung transplant
Time Frame
Through study completion, approximately 1 year post-transplant
Title
Aspiration event
Description
Presence of clinical aspiration event during index hospital admission for lung transplant
Time Frame
Through study completion, approximately 1 year post-transplant
Title
Graft survival
Description
Duration of graft functioning from transplant until patient death or re-transplantation
Time Frame
Through study completion, approximately 1 year post-transplant
Title
Accelerometer step change
Description
Change in steps from pre-transplant to post-transplant
Time Frame
pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Title
Accelerometer energy expenditure
Description
Change in energy expenditure from pre-transplant to post-transplant
Time Frame
pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Title
Accelerometer time ambulating
Description
Change in time ambulating from pre-transplant to post-transplant
Time Frame
pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria (pre-transplant): 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 Inclusion Criteria (post-transplant) 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 Exclusion Criteria (pre-transplant): 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) Exclusion Criteria (post-transplant) Bed rest order placed Requiring invasive mechanical ventilation during the day/night
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie Budev, DO
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients

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