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

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

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.

Study Overview

• Status: Completed
• Conditions: Rehabilitation; Lung Transplant
• Intervention / Treatment: Other: Physical rehabilitation.

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • The Alfred

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Control; 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.	Other: Physical rehabilitation.; Early mobility, aerobic exercise, upper and lower limb strength and flexibility training, trunk mobility and core strengthening, inclusive of respiratory therapy and education.
EXPERIMENTAL: Experimental; 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.	Other: Physical rehabilitation.; Early mobility, aerobic exercise, upper and lower limb strength and flexibility training, trunk mobility and core strengthening, inclusive of respiratory therapy and education.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to deliver intensive inpatient physical rehabilitation (feasibility).	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.	Patient length of stay is typically two to three weeks following lung transplant surgery.
Incidence of treatment and non-treatment related adverse events (safety).	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.	Patient length of stay is typically two to three weeks following lung transplant surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six-minute walk test.	Distance walked in six minutes.	Pre-transplant results if available. Repeated at 3 and 10 weeks.
Physical activity monitoring (Dynaport®).	Physical activity levels.	7 days (5 days of data) at post-operative day 10 and at 10 weeks.
Pain visual analogue scale (VAS).	0-10 pain score.	Once daily on physical activity monitoring days, from day 10 - 16 post-transplant, repeated for seven days at 10 weeks post-transplant.
EuroQol EQ-5D-5L.	Health-related quality of life questionnaire.	Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Sit to stand test - 60 second.	Amount of sit-stands completed over 60 seconds.	Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.
Grip strength.	Hand-held dynamometer.	Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Modified Iowa Level of Assistance Scale (MILOA).	A valid, reliable and responsive scale of physical capacity in the post-operative patient.	Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay.	Length of intensive care and total inpatient stay.	Until inpatient discharge, estimated between two to three weeks.
Readmission rates	Readmission rates to the acute setting for the duration of study follow-up.	Inpatient discharge (2-3 weeks) to 10 weeks.
Discharge destination.	Requirement for formal inpatient physical rehabilitation vs home.	Inpatient (acute) discharge, estimated between two to three weeks.
Rejection rates.	Evidence of any form of chronic lung allograft dysfunction / antibody mediated rejection.	Baseline to 10 weeks.
Spirometry	Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and forced expiratory ratio (FER)).	10 weeks.
Adherence to outpatient pulmonary rehabilitation.	Post-transplant outpatient physical rehabilitation uptake - sessions completed.	Inpatient discharge (2-3 weeks) to 10 weeks.

Collaborators and Investigators

• Sponsor: The Alfred
• Investigators: Principal Investigator: Benjamin J Tarrant, B.Physio, The Alfred

Publications and helpful links

General Publications

• 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. 2022 Feb 22:1-11. doi: 10.1080/09593985.2022.2041779. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2019
• Primary Completion (ACTUAL): March 23, 2020
• Study Completion (ACTUAL): May 15, 2020

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (ACTUAL): March 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 49/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared outside of this trial.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No