Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation (PIRATE)

The Alfred

Status: Completed

Conditions: Rehabilitation; Lung Transplant

Treatments: Other: Physical rehabilitation.

Study type: Interventional

Funder types: Other

Identifiers

NCT03095859

49/17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Control

Active Comparator group

Description:

Standard care (once daily physical rehabilitation, approx. 30 minutes). Standard care will consist of physical exercise, such as early mobility, endurance training, upper limb, lower limb and trunk activity. This will involve non-physical interventions including respiratory therapy, airway clearance and patient and carer education.

Treatment:

Other: Physical rehabilitation.

Experimental

Experimental group

Description:

Early intensive physical rehabilitation, which will consist of standard care plus one additional treatment per day. The additional early intensive physical rehabilitation session provided to the experimental group will allow for progression of aerobic, strength and flexibility exercise and / or completion of a more comprehensive physical rehabilitation program.

Treatment:

Other: Physical rehabilitation.