Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients



Status:Recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:August 15, 2018
End Date:December 31, 2020
Contact:Marie Budev, DO
Email:budevm@ccf.org
Phone:216-444-3194

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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.

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.

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
We found this trial at
1
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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