Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation

Rehabilitation Clinical Trial

— PIRATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03095859
• Other study ID #: 49/17
• Status: Completed
• Phase: N/A
• Start date: February 4, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: July 2020
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 15, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant
• Rehabilitation

Intervention

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.

Locations

Country	Name	City	State
Australia	The Alfred	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay.	Length of intensive care and total inpatient stay.	Until inpatient discharge, estimated between two to three weeks.
Other	Readmission rates	Readmission rates to the acute setting for the duration of study follow-up.	Inpatient discharge (2-3 weeks) to 10 weeks.
Other	Discharge destination.	Requirement for formal inpatient physical rehabilitation vs home.	Inpatient (acute) discharge, estimated between two to three weeks.
Other	Rejection rates.	Evidence of any form of chronic lung allograft dysfunction / antibody mediated rejection.	Baseline to 10 weeks.
Other	Spirometry	Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and forced expiratory ratio (FER)).	10 weeks.
Other	Adherence to outpatient pulmonary rehabilitation.	Post-transplant outpatient physical rehabilitation uptake - sessions completed.	Inpatient discharge (2-3 weeks) to 10 weeks.
Primary	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.
Primary	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	Six-minute walk test.	Distance walked in six minutes.	Pre-transplant results if available. Repeated at 3 and 10 weeks.
Secondary	Physical activity monitoring (Dynaport®).	Physical activity levels.	7 days (5 days of data) at post-operative day 10 and at 10 weeks.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Grip strength.	Hand-held dynamometer.	Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Secondary	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.