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NCT Number: NCT03636412

Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambulation

Other

An ambulator will walk with a patient three times a day, based on physical therapy recommendations.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Acronym: iFRAIL

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Aug 17, 2018
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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