Lung TransplantPIRATENCT03095859
Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation
A study testing Physical rehabilitation. in people with Lung Transplant and Rehabilitation, run by The Alfred at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant, Rehabilitation
- What is being tested?
- Physical rehabilitation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Feb 2019to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Transplant, Rehabilitation
- Being tested
- Physical rehabilitation.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physical rehabilitation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Patient length of stay is typically two to three weeks following lung transplant surgery.
Secondary outcomes (7)
Six-minute walk test.
Distance walked in six minutes.
Measured: Pre-transplant results if available. Repeated at 3 and 10 weeks.
Physical activity monitoring (Dynaport®).
Physical activity levels.
Measured: 7 days (5 days of data) at post-operative day 10 and at 10 weeks.
Pain visual analogue scale (VAS).
0-10 pain score.
Measured: 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.
Measured: 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.
Measured: Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.
Grip strength.
Hand-held dynamometer.
Measured: 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.
Measured: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start4 Feb 2019
- Primary completion23 Mar 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung TransplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, parallel feasibility trial. Stratification as per: \<55 years of age ≥ 55 years
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Alfred
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Benjamin Tarrant, The Alfred
- Investigators
- Benjamin J Tarrant, B.Physio, Principal investigator, The Alfred
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03095859
- Sponsor's protocol ID
- 49/17
- Acronym
- PIRATE
- Status last verified
- Jul 2020
- First submitted
- 10 Mar 2017
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared outside of this trial.
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. 2023 Jul 3;39(7):1406-1416. doi: 10.1080/09593985.2022.2041779. Epub 2022 Feb 22.
PubMed 35193445
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03095859
- Acronym / sponsor ID
- PIRATE / 49/17
- Conditions
- Lung Transplant, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The AlfredUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, parallel feasibility trial. Stratification as per: <55 years of age ≥ 55 years
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Physical rehabilitation.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 | Other: Physical rehabilitation.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Control, Experimental |
Primary outcome
Ability to deliver intensive inpatient physical rehabilitation (feasibility).
Time frame: Patient length of stay is typically two to three weeks following lung transplant surgery.
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.
Incidence of treatment and non-treatment related adverse events (safety).
Time frame: Patient length of stay is typically two to three weeks following lung transplant surgery.
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.
7 secondary outcomes
Six-minute walk test.
Time frame: Pre-transplant results if available. Repeated at 3 and 10 weeks.
Physical activity monitoring (Dynaport®).
Time frame: 7 days (5 days of data) at post-operative day 10 and at 10 weeks.
Pain visual analogue scale (VAS).
Time frame: 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.
Time frame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Sit to stand test - 60 second.
Time frame: Baseline (within 3 days from first time to mobilise), inpatient discharge (2-3 weeks), one month and three months.
Grip strength.
Time frame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Modified Iowa Level of Assistance Scale (MILOA).
Time frame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Derived from this study: PubMed 35193445Tarrant 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.
- Individual participant dataSharing planned: No. IPD will not be shared outside of this trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin J Tarrant, B.Physio principal investigator
The Alfred
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical rehabilitation. in people with Lung Transplant and Rehabilitation, run by The Alfred at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability to deliver intensive inpatient physical rehabilitation (feasibility). (time frame: Patient length of stay is typically two to three weeks following lung transplant surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03095859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.