Improving Frailty With a Rigorous Ambulation Intervention in Lung Transplant Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Hospital Length of Stay
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Hospital Length of Stay
时间窗: 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
Regular Nursing Floor Length of Stay
时间窗: 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
30-day readmission
时间窗: 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
次要结局
- Change in nutritional status; serum albumin(pre-transplant to 1 year following transplant)
- Change in AMPAC/6-click score(pre-transplant to 1 year following transplant)
- Change in eyeball frailty assessment(pre-transplant to 1 year following transplant)
- Change in short physical performance battery(pre-transplant to 1 year following transplant)
- Change in nutritional status; serum protein(pre-transplant to 1 year following transplant)
- Change in nutritional status; BMI(pre-transplant to 1 year following transplant)
- Accelerometer step change(pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant)
- Accelerometer energy expenditure(pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant)
- Aspiration event(Through study completion, approximately 1 year post-transplant)
- Change in sarcopenia(pre-transplant to 1 year following transplant)
- Readmission to ICU(Through study completion, approximately 1 year post-transplant)
- In-hospital falls(Through study completion, approximately 1 year post-transplant)
- Change in physical frailty phenotype(pre-transplant to 1 year following transplant)
- Presence of aspiration(pre-transplant to 1 year following transplant)
- Graft survival(Through study completion, approximately 1 year post-transplant)
- Accelerometer time ambulating(pre-transplant (weeks to a year to more) and immediately after transplant, up to 1 year post-transplant)