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临床试验/NCT03095859
NCT03095859已完成不适用

Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation: A Feasibility Study

The Alfred2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
Ability to deliver intensive inpatient physical rehabilitation (feasibility).

研究概览

简要总结

This randomized, feasibility trial (n=40) will compare the effects of an intensive, twice daily inpatient physical rehabilitation program against standard care (once daily) following double lung transplantation.

详细描述

This trial will involve the participation of patients post lung transplantation, in the initial post-operative period. Recruitment will take place as soon as the patient is medically safe and willing to commence physical rehabilitation within the intensive care unit. Current, standard care for inpatient physical rehabilitation post lung transplant involves a once daily session of physiotherapy for the duration of the patient's initial inpatient stay, and consists of early mobility, aerobic exercise, upper and lower limb strengthening and flexibility or core muscle re-training.

This trial aims to assess the feasibility and safety of twice daily physical rehabilitation sessions during the post-operative period following lung transplantation. The content of the additional physical rehabilitation session will not differ from, but will complement current standard care, and will be delivered by a trained research assistant or physiotherapist. To the investigator's knowledge, there is no current evidence to support the dosage and intensity of inpatient physical rehabilitation following lung transplantation, and it is unsatisfactory to use evidence from other patient groups to guide practice in this area.

To assess the feasibility of an intensive, inpatient physical rehabilitation program post lung transplantation, the investigators will collect the following data: Number of patients eligible for study inclusion; number of patients consented; number of additional, intensive physical rehabilitation sessions completed; reasons for non-completion of sessions; and attrition, or patient withdrawal rate. In order to assess the safety of the program, the investigators will also assess for evidence of early, acute rejection of the transplanted lungs based on the routine collection of tissue samples, and adverse events. Adverse events will be defined as any event likely caused by acute physical rehabilitation, including musculoskeletal injury, patient fall and surgical wound breakdown.

These assessments will be complemented by a number of physical and psychological outcome measures and patient statistics, including tests of physical capacity, participation and strength, quality of life, requirements for additional physical rehabilitation and/or hospital readmissions within 10 weeks of study commencement, discharge destination and patient length of stay data. Assessments will be completed within 3 days of first time to mobilize, after three weeks and finally after 10 weeks post-transplant.

The investigators hypothesise that an intensive, physical rehabilitation program will be safe and feasible to implement in the post-operative phase post lung transplantation, and that participants in the intensive rehabilitation group will be more active at 10 days, and at 10 weeks than those receiving standard, post lung transplant physical rehabilitation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Single blind study. Treating medical team and therapist delivering standard care will remain blinded to participant allocation. Participants and therapist delivering intensive intervention will be unable to be blinded as they will be receiving / providing intervention. Outcome assessors will be blinded to group allocation.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medically stable and able to participate in physical rehabilitation as directed by the treating medical team and primary physiotherapist
  • All transplant indications will be included, including re-transplantation
  • Will include interstate patients (South Australia, Tasmania) as all patients routinely remain in Victoria attending post-transplant clinic and rehabilitation for three months post operatively

排除标准

  • Medically unable to mobilise (e.g. cardiovascular instability)
  • Critically unwell (ECMO, CVVHDF etc.)
  • <18 years old (paediatric lung transplant)
  • Heart-lung transplant
  • Single lung transplant (SLTx)
  • Unable to provide written informed consent

结局指标

主要结局

Ability to deliver intensive inpatient physical rehabilitation (feasibility).

时间窗: Patient length of stay is typically two to three weeks following lung transplant surgery.

Quantified by number of patients eligible for inclusion; number of patients consented; number of additional, intensive physical rehabilitation sessions completed during the initial, inpatient stay post operatively; reasons for non-completion of sessions; and attrition. This will be aggregated into an overall percentage of successful delivery of intervention.

Incidence of treatment and non-treatment related adverse events (safety).

时间窗: Patient length of stay is typically two to three weeks following lung transplant surgery.

Evidence of early, acute rejection on bronchoscopic biopsy and adverse events. Adverse events will be defined as any adverse outcome during the study period, including but not limited to events that could be related to acute physical rehabilitation such as musculoskeletal injury, patient fall and surgical wound dehiscence or breakdown.

次要结局

  • Pain visual analogue scale (VAS).(Once daily on physical activity monitoring days, from day 10 - 16 post-transplant, repeated for seven days at 10 weeks post-transplant.)
  • Modified Iowa Level of Assistance Scale (MILOA).(Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.)
  • Six-minute walk test.(Pre-transplant results if available. Repeated at 3 and 10 weeks.)
  • Physical activity monitoring (Dynaport®).(7 days (5 days of data) at post-operative day 10 and at 10 weeks.)
  • EuroQol EQ-5D-5L.(Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.)
  • Sit to stand test - 60 second.(Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.)
  • Grip strength.(Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.)

研究者

发起方
The Alfred
申办方类型
Other
责任方
Principal Investigator
主要研究者

Benjamin Tarrant

Senior Clinician Physiotherapist - Lung Transplant

The Alfred

研究点 (2)

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