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

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ClinicalTrials.gov Identifier: NCT03095859
Recruitment Status : Recruiting
First Posted : March 30, 2017
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Benjamin Tarrant, The Alfred

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.

Condition or disease Intervention/treatment Phase
Lung Transplant Rehabilitation Other: Physical rehabilitation. Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Randomized, parallel feasibility trial.

Stratification as per:

<55 years of age

≥ 55 years

Masking: Double (Care Provider, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Post-operative, Inpatient Rehabilitation After Lung Transplant Evaluation: A Feasibility Study
Actual Study Start Date : February 4, 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


  2. 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.


Secondary Outcome Measures :
  1. Six-minute walk test. [ Time Frame: Pre-transplant results if available. Repeated at 3 and 10 weeks. ]
    Distance walked in six minutes.

  2. Physical activity monitoring (Dynaport®). [ Time Frame: 7 days (5 days of data) at post-operative day 10 and at 10 weeks. ]
    Physical activity levels.

  3. 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. ]
    0-10 pain score.

  4. EuroQol EQ-5D-5L. [ Time Frame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant. ]
    Health-related quality of life questionnaire.

  5. 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. ]
    Amount of sit-stands completed over 60 seconds.

  6. Grip strength. [ Time Frame: Baseline (within 3 days from first time to mobilise), 3 weeks and 10 weeks post-transplant. ]
    Hand-held dynamometer.

  7. 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. ]
    A valid, reliable and responsive scale of physical capacity in the post-operative patient.


Other Outcome Measures:
  1. Length of stay. [ Time Frame: Until inpatient discharge, estimated between two to three weeks. ]
    Length of intensive care and total inpatient stay.

  2. Readmission rates [ Time Frame: Inpatient discharge (2-3 weeks) to 10 weeks. ]
    Readmission rates to the acute setting for the duration of study follow-up.

  3. Discharge destination. [ Time Frame: Inpatient (acute) discharge, estimated between two to three weeks. ]
    Requirement for formal inpatient physical rehabilitation vs home.

  4. Rejection rates. [ Time Frame: Baseline to 10 weeks. ]
    Evidence of any form of chronic lung allograft dysfunction / antibody mediated rejection.

  5. Spirometry [ Time Frame: 10 weeks. ]
    Forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and forced expiratory ratio (FER)).

  6. Adherence to outpatient pulmonary rehabilitation. [ Time Frame: Inpatient discharge (2-3 weeks) to 10 weeks. ]
    Post-transplant outpatient physical rehabilitation uptake - sessions completed.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095859


Contacts
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Contact: Benjamin J Tarrant, B.Physio +613 9076 3450 b.tarrant@alfred.org.au
Contact: Anne A Holland, BAppSci; PHD +613 9479 6744 a.holland@alfred.org.au

Locations
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Australia, Victoria
The Alfred Recruiting
Melbourne, Victoria, Australia, 3004
Contact: Benjamin J Tarrant, BPhysio    +613 9076 3450 ext pager 5036    b.tarrant@alfred.org.au   
Contact: Anne E Holland, BAppSciPhD    0419 379 821    a.holland@alfred.org.au   
Principal Investigator: Benjamin J Tarrant, BPhysio         
Sub-Investigator: Greg I Snell, MbbsFracpMd         
Principal Investigator: Anne E Holland, BAppSciPhD         
Sub-Investigator: Louise M Fuller, BAppSciPhys         
Sub-Investigator: Bruce R Thompson, BAppSciPHD         
Sub-Investigator: Brenda M Button, DipPhysPhD         
Sub-Investigator: Rebecca Robinson, BSciHonMPhtySt         
Sub-Investigator: Megan Poulsen, BPhysio         
Sponsors and Collaborators
The Alfred
Investigators
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Principal Investigator: Benjamin J Tarrant, B.Physio The Alfred

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Responsible Party: Benjamin Tarrant, Senior Clinician Physiotherapist - Lung Transplant, The Alfred
ClinicalTrials.gov Identifier: NCT03095859     History of Changes
Other Study ID Numbers: 49/17
First Posted: March 30, 2017    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared outside of this trial.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No