Clinical trial NCT03095859: Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation
Official title: Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Transplant
Rehabilitation
Lead sponsor: The Alfred
Sponsor class: OTHER
First posted: 2017-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, parallel feasibility trial.

Stratification as per:

\<55 years of age

≥ 55 years
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ability to deliver intensive inpatient physical rehabilitation (feasibility).
timeFrame: Patient length of stay is typically two to three weeks following lung transplant surgery.
measure: Incidence of treatment and non-treatment related adverse events (safety).
timeFrame: Patient length of stay is typically two to three weeks following lung transplant surgery.
Secondary outcomes:
measure: Six-minute walk test.
timeFrame: Pre-transplant results if available. Repeated at 3 and 10 weeks.
measure: Physical activity monitoring (Dynaport®).
timeFrame: 7 days (5 days of data) at post-operative day 10 and at 10 weeks.
measure: Pain visual analogue scale (VAS).
timeFrame: Once daily on physical activity monitoring days, from day 10 - 16 post-transplant, repeated for seven days at 10 weeks post-transplant.
measure: EuroQol EQ-5D-5L.
timeFrame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
measure: Sit to stand test - 60 second.
timeFrame: Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.
measure: Grip strength.
timeFrame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
measure: Modified Iowa Level of Assistance Scale (MILOA).
timeFrame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Other outcomes:
measure: Length of stay.
timeFrame: Until inpatient discharge, estimated between two to three weeks.
measure: Readmission rates
timeFrame: Inpatient discharge (2-3 weeks) to 10 weeks.
measure: Discharge destination.
timeFrame: Inpatient (acute) discharge, estimated between two to three weeks.
measure: Rejection rates.
timeFrame: Baseline to 10 weeks.
measure: Spirometry
timeFrame: 10 weeks.
measure: Adherence to outpatient pulmonary rehabilitation.
timeFrame: Inpatient discharge (2-3 weeks) to 10 weeks.
Locations:
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
Study officials:
affiliation: The Alfred
name: Benjamin J Tarrant, B.Physio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tarrant BJ, Quinn E, Robinson R, Poulsen M, Fuller L, Snell G, Thompson BR, Button BM, Holland AE. Post-operative, inpatient rehabilitation after lung transplant evaluation (PIRATE): A feasibility randomized controlled trial. Physiother Theory Pract. 2023 Jul 3;39(7):1406-1416. doi: 10.1080/09593985.2022.2041779. Epub 2022 Feb 22.