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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03095859




Registration number
NCT03095859
Ethics application status
Date submitted
10/03/2017
Date registered
30/03/2017
Date last updated
9/07/2020

Titles & IDs
Public title
Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation
Scientific title
Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation: A Feasibility Study
Secondary ID [1] 0 0
49/17
Universal Trial Number (UTN)
Trial acronym
PIRATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Transplant 0 0
Rehabilitation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Physical rehabilitation.

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.

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 interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ability to deliver intensive inpatient physical rehabilitation (feasibility).
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Patient length of stay is typically two to three weeks following lung transplant surgery.
Primary outcome [2] 0 0
Incidence of treatment and non-treatment related adverse events (safety).
Assessment method [2] 0 0
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.
Timepoint [2] 0 0
Patient length of stay is typically two to three weeks following lung transplant surgery.
Secondary outcome [1] 0 0
Six-minute walk test.
Assessment method [1] 0 0
Distance walked in six minutes.
Timepoint [1] 0 0
Pre-transplant results if available. Repeated at 3 and 10 weeks.
Secondary outcome [2] 0 0
Physical activity monitoring (Dynaport®).
Assessment method [2] 0 0
Physical activity levels.
Timepoint [2] 0 0
7 days (5 days of data) at post-operative day 10 and at 10 weeks.
Secondary outcome [3] 0 0
Pain visual analogue scale (VAS).
Assessment method [3] 0 0
0-10 pain score.
Timepoint [3] 0 0
Once daily on physical activity monitoring days, from day 10 - 16 post-transplant, repeated for seven days at 10 weeks post-transplant.
Secondary outcome [4] 0 0
EuroQol EQ-5D-5L.
Assessment method [4] 0 0
Health-related quality of life questionnaire.
Timepoint [4] 0 0
Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Secondary outcome [5] 0 0
Sit to stand test - 60 second.
Assessment method [5] 0 0
Amount of sit-stands completed over 60 seconds.
Timepoint [5] 0 0
Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.
Secondary outcome [6] 0 0
Grip strength.
Assessment method [6] 0 0
Hand-held dynamometer.
Timepoint [6] 0 0
Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Secondary outcome [7] 0 0
Modified Iowa Level of Assistance Scale (MILOA).
Assessment method [7] 0 0
A valid, reliable and responsive scale of physical capacity in the post-operative patient.
Timepoint [7] 0 0
Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/02/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/05/2020
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Benjamin J Tarrant, B.Physio
Address 0 0
The Alfred
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT03095859