Clinical trial NCT03636412: Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
Official title: Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transplant-Related Disorder
Frail Elderly Syndrome
Sarcopenia
Lung Graft Dysfunction
Mobility Limitation
Keywords: lung transplant
frailty
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Hospital Length of Stay
timeFrame: Through study completion, approximately 1 year post-transplant
measure: Regular Nursing Floor Length of Stay
timeFrame: Through study completion, approximately 1 year post-transplant
measure: 30-day readmission
timeFrame: Up to 30 days following discharge
Secondary outcomes:
measure: Change in physical frailty phenotype
timeFrame: pre-transplant to 1 year following transplant
measure: Change in short physical performance battery
timeFrame: pre-transplant to 1 year following transplant
measure: Change in AMPAC/6-click score
timeFrame: pre-transplant to 1 year following transplant
measure: Change in sarcopenia
timeFrame: pre-transplant to 1 year following transplant
measure: Change in nutritional status; serum albumin
timeFrame: pre-transplant to 1 year following transplant
measure: Change in nutritional status; serum protein
timeFrame: pre-transplant to 1 year following transplant
measure: Change in nutritional status; BMI
timeFrame: pre-transplant to 1 year following transplant
measure: Change in eyeball frailty assessment
timeFrame: pre-transplant to 1 year following transplant
measure: Presence of aspiration
timeFrame: pre-transplant to 1 year following transplant
measure: Readmission to ICU
timeFrame: Through study completion, approximately 1 year post-transplant
measure: In-hospital falls
timeFrame: Through study completion, approximately 1 year post-transplant
measure: Aspiration event
timeFrame: Through study completion, approximately 1 year post-transplant
measure: Graft survival
timeFrame: Through study completion, approximately 1 year post-transplant
measure: Accelerometer step change
timeFrame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
measure: Accelerometer energy expenditure
timeFrame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
measure: Accelerometer time ambulating
timeFrame: pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Marie Budev, DO
role: PRINCIPAL_INVESTIGATOR
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