Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12613000941763
Ethics application status
Approved
Date submitted
11/08/2013
Date registered
26/08/2013
Date last updated
15/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Upper limb rehabilitation following lung transplantation
Scientific title
In bilateral lung transplantation recipients, is an upper limb rehabilitation program more effective than no program in improving pain, strength and bone healing?
Secondary ID [1] 283002 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Upper limb pain, movement and strength after lung transplantation 289830 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290186 290186 0 0
Physiotherapy
Respiratory 290208 290208 0 0
Other respiratory disorders / diseases
Surgery 290209 290209 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention= upper limb rehabilitation program, 1 hour session three times weekly for 12 weeks consisting of erogmometer, treadmill, lower limb & upper limb strengthening exercise program.
Adherence is monitored by an attendance spreadsheet including recording reasons for non attendance. The non UL training group will be scheduled at a different time frame to prevent contamination of groups. Other parts of the program, treadmill, ergometer & Lower limb exercises remain the same for both groups.Sessions are administered by 2 physiotherapists in a group format.
Intervention code [1] 287717 0
Rehabilitation
Comparator / control treatment
Rehabilitation program is a thrice weekly 1 hour ssession for 12 weeks that consists of ergomometer & treadmill training and lower limb strength training. Attendance is recorded and reasons for non attendance are also recorded. The non UL group will be scheduled at a different time to prevent cross contamination of groups.Sessions are administered by 2 physiotherapists in a group format.
Control group
Active

Outcomes
Primary outcome [1] 290216 0
Pain as measured on body chart and VAS scale on 100mm scale
Timepoint [1] 290216 0
commencement of rehabilitation program is baseline measure(usually at 2/52 post op) , 6 weeks after baseline, 12 weeks after baseline and 6 months after lung transplantation
Secondary outcome [1] 304124 0
muscle strength using hand held dynamometer
Timepoint [1] 304124 0
at commencement of rehabilitation is baseline measure (usually at 2/52 weeks post op), 6 weeks post baseline, 12 weeks after baseline and 6 months after lung transpalntation
Secondary outcome [2] 304125 0
bony separation of cut sternum for clam shell incisions using 2D ultrasound to measure bone separation in mm.
Timepoint [2] 304125 0
commencement of rehabilitation is baseline measure (usually at 2/52 post op), 6 weeks after baseline, 12 weeks after baseline and 6 months after lung transplantation

Eligibility
Key inclusion criteria
bilateral sequential lung transplantation via clam shell or bilateral anterior thoracotomy incisions
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
single lung transplantation, interstate patients other than Victorians, age < 18, patients admitted to inpatient rehabilitation facility

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)
enrollment by independent researcher
randomised by incision type (either clam shell or bilateral anterior thoracotomy)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomised by opening an opaque, sealed envelope with allocation group details. Randomisation will be by computer generated number sequencing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The probability is 80 percent that the study will detect a treatment difference at a two-sided 0.05 significance level, if the true difference between groups is 8 points on the SF-36 bodily pain domain, representing the minimal important difference for this domain. This is based on the assumption that the standard deviation of the response variable is 12 points.
SF 36 pain domain was used to power the study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2013
Actual
1/08/2013
Date of last participant enrolment
Anticipated
1/08/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 287770 0
Hospital
Name [1] 287770 0
The Alfred
Country [1] 287770 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Commercial rd
Melbourne 3004
Victoria
Country
Australia
Secondary sponsor category [1] 286497 0
None
Name [1] 286497 0
Address [1] 286497 0
Country [1] 286497 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289717 0
The Alfred Hospital ethics and research committee
Ethics committee address [1] 289717 0
Commercial rd
Melbourne 3004
Victoria
Ethics committee country [1] 289717 0
Australia
Date submitted for ethics approval [1] 289717 0
Approval date [1] 289717 0
31/01/2013
Ethics approval number [1] 289717 0
487/12
Ethics committee name [2] 289718 0
La Trobe University human ethics committee
Ethics committee address [2] 289718 0
La Trobe University Ethics Unit
Bundoora Campus
Bundoora 3083
Victoria
Ethics committee country [2] 289718 0
Australia
Date submitted for ethics approval [2] 289718 0
Approval date [2] 289718 0
01/03/2013
Ethics approval number [2] 289718 0
4877/12

Summary
Brief summary
Musculoskeletal complications following bilateral lung transplantation represent a significant problem which may delay recovery and return to normal daily activities. There is no evidence to support the current upper limb rehabilitation exercise program that form part of post transplantation programs. Therefore this study was designed to investigate the impact of the current exercise programs on the healing breast bone, muscle strength recovery and importantly on pain levels to aid return to functional performance.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42102 0
Ms Louise Fuller
Address 42102 0
Physiotherapy Department
The Alfred
Commercial Rd
Melbourne
3004
Victoria
Country 42102 0
Australia
Phone 42102 0
+61 3 90763450
Fax 42102 0
Email 42102 0
[email protected]
Contact person for public queries
Name 42103 0
Ms Louise Fuller
Address 42103 0
Physiotherapy Department
The Alfred
Commercial Rd
Melbourne 3004
Victoria
Country 42103 0
Australia
Phone 42103 0
+61 3 90763450
Fax 42103 0
Email 42103 0
[email protected]
Contact person for scientific queries
Name 42104 0
Ms Louise Fuller
Address 42104 0
Physiotherapy Department
The Alfred
Commercial Rd
Melbourne 3004
Victoria
Country 42104 0
Australia
Phone 42104 0
+61 3 90763450
Fax 42104 0
Email 42104 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of Upper Limb Rehabilitation Compared to No Upper Limb Rehabilitation in Lung Transplant Recipients: A Randomized Controlled Trial.2018https://dx.doi.org/10.1016/j.apmr.2017.09.115
N.B. These documents automatically identified may not have been verified by the study sponsor.