Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients

Study Overview
=================
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.

Official Title
-----------------
Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients

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

Intervention / Treatment
-----------------
* Other: Ambulation


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory Intervention<br>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<br>* An ambulator will walk with a patient three times a day, based on physical therapy recommendations.<br>|
| No Intervention: No Ambulator<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical frailty phenotype | Change in physical frailty phenotype pre and post-transplant | pre-transplant to 1 year following transplant | 
| Change in short physical performance battery | Change in short physical performance battery pre and post-transplant | pre-transplant to 1 year following transplant | 
| Change in AMPAC/6-click score | Change in AMPAC/6-click score pre and post-transplant | pre-transplant to 1 year following transplant | 
| Change in sarcopenia | Change in sarcopenia pre and post-transplant (m2) | pre-transplant to 1 year following transplant | 
| Change in nutritional status; serum albumin | Change in nutritional status; serum albumin pre and post-transplant (g/dL) | pre-transplant to 1 year following transplant | 
| Change in nutritional status; serum protein | Change in nutritional status; serum protein pre and post-transplant (g/dL) | pre-transplant to 1 year following transplant | 
| Change in nutritional status; BMI | Change in nutritional status; BMI pre and post-transplant (kg/m2) | pre-transplant to 1 year following transplant | 
| Change in eyeball frailty assessment | Change in eyeball frailty assessment pre and post-transplant | pre-transplant to 1 year following transplant | 
| Presence of aspiration | Presence of aspiration pre and post-transplant | pre-transplant to 1 year following transplant | 
| Readmission to ICU | Readmission to ICU during index hospitalization for lung transplant | Through study completion, approximately 1 year post-transplant | 
| In-hospital falls | Clinical documentation of a fall during index hospital admission for lung transplant | Through study completion, approximately 1 year post-transplant | 
| Aspiration event | Presence of clinical aspiration event during index hospital admission for lung transplant | Through study completion, approximately 1 year post-transplant | 
| Graft survival | Duration of graft functioning from transplant until patient death or re-transplantation | Through study completion, approximately 1 year post-transplant | 
| Accelerometer step change | Change in steps from pre-transplant to post-transplant | pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant | 
| Accelerometer energy expenditure | Change in energy expenditure from pre-transplant to post-transplant | pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant | 
| Accelerometer time ambulating | Change in time ambulating from pre-transplant to post-transplant | pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung transplant, frailty