Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation

NCT03095859 | Completed

• 1 other identifier: 49/17
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplant; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• 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.

• 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.

• 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.

Other Outcomes (6)

• Length of stay.

  Until inpatient discharge, estimated between two to three weeks.

• Readmission rates

  Inpatient discharge (2-3 weeks) to 10 weeks.

• Discharge destination.

  Inpatient (acute) discharge, estimated between two to three weeks.

Study Arms (2)

Control

ACTIVE COMPARATOR

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.

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.

Interventions

Physical rehabilitation. OTHER

Early mobility, aerobic exercise, upper and lower limb strength and flexibility training, trunk mobility and core strengthening, inclusive of respiratory therapy and education.

Control; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alfred: lead

Study Sites (1)

The Alfred

Melbourne, Victoria, 3004, Australia

Location

Related Publications (1)

• 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.

  PMID: 35193445 DERIVED

Study Officials

• Benjamin J Tarrant, B.Physio

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Clinician Physiotherapist - Lung Transplant

Model Details: Randomized, parallel feasibility trial. Stratification as per: \<55 years of age ≥ 55 years

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: March 30, 2017
• Study Start: February 4, 2019
• Primary Completion: March 23, 2020
• Study Completion: May 15, 2020
• Last Updated: July 9, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)