Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000201673
Ethics application status
Approved
Date submitted
18/08/2005
Date registered
23/08/2005
Date last updated
28/11/2007
Type of registration
Prospectively registered

Titles & IDs
Public title
Do physiotherapy interventions reduce the incidence of postoperative complications in patients following pulmonary resection via thoracotomy?
Scientific title
Do physiotherapy interventions reduce the incidence of postoperative complications in patients following pulmonary resection via thoracotomy? A randomised controlled trial
Universal Trial Number (UTN)
Trial acronym
PMOTS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rehabilitation following pulmonary resection 282 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318 318 0 0
Other physical medicine / rehabilitation
Physical Medicine / Rehabilitation 319 319 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effectiveness of physiotherapy treatments following surgical removal of part or whole of one lung, its purpose being to assess whether patients require physiotherapy treatment after their surgery, specifically considering:
a. Whether physiotherapy is effective in reducing postoperative lung complications
b. Whether physiotherapy is effective in preventing postoperative shoulder problems
c. How the above impact upon length of hospital stay, quality of life and ability to perform everyday activities.
This will be investigated by undertaking a trial in which patients will be allocated to either:
a. A group receiving supervision of postoperative breathing and shoulder/trunk exercises
b. A group receiving a physiotherapy information sheet but no physiotherapy supervision of postoperative breathing and shoulder/trunk exercises
Measures used to evaluate the effectiveness of physiotherapy treatments will be:
a. Incidence of lung complications
b. Shoulder complications (including shoulder movement, muscle strength and level of function in daily activities)
c. Quality of life questionnaire
d. Length of stay
All patients will be given a preoperative physiotherapy exercise and advice sheet. Treatment group patients will be seen by a physiotherapist daily during their postoperative stay and respiratory and musculoskeletal interventions administered/supervised. They will be given an individualised exercise sheet upon discharge.
Intervention code [1] 206 0
None
Comparator / control treatment
Control group patients will receive no physiotherapy but recieve usual care from nursing and medical staff and encourge to perform exercises from their preoperative sheet. All patients will be assessed pre operatively, daily whilst inpatients, at discharge from hospital and and 1/12 and 3/12 post hospital discharge
Control group
Active

Outcomes
Primary outcome [1] 373 0
Incidence of post operative pulmonary complications (PPC).
Timepoint [1] 373 0
Measured daily post operatively to discharge from hospital.
Secondary outcome [1] 828 0
Length of hospital stay.
Timepoint [1] 828 0
Measured preoperatively, at discharge from hospital, at 1 month and 3 months post operatively.
Secondary outcome [2] 829 0
Shoulder range of movement.
Timepoint [2] 829 0
Measured preoperatively, at discharge from hospital, at 1 month and 3 months post operatively.
Secondary outcome [3] 830 0
Shoulder muscle strength.
Timepoint [3] 830 0
Measured preoperatively, at discharge from hospital, at 1 month and 3 months post operatively.
Secondary outcome [4] 831 0
Shoulder function ( via activity of daily living scale).
Timepoint [4] 831 0
Measured preoperatively, at discharge from hospital, at 1 month and 3 months post operatively.
Secondary outcome [5] 832 0
Quality of Life ( via SF36 v2).
Timepoint [5] 832 0
Measured preoperatively, at discharge from hospital, at 1 month and 3 months post operatively.

Eligibility
Key inclusion criteria
Adult patients admitted to Auckland City Hospital. Undergoing elective lung resection via open thoracotomy. -Ability to understand written and spoken English. -Willingness to take part in the study and give informed written consent.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects unable or unwilling to comply with treatment. Subjects requiring preoperative physiotherapy assessment and treatment. Subjects with tumour invasion into chest wall or brachial plexus.

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)
Randomisation will be undertaken using computer generated random number tables. Group allocation stored in sealed envelopes. On day 1 postoperatively prior to any physiotherapy interventions, subjects will be randomly allocated to Group 1 (treatment) or Group 2 (control) using the above methods.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
180
Accrual to date
Final
Recruitment outside Australia
Country [1] 138 0
New Zealand
State/province [1] 138 0

Funding & Sponsors
Funding source category [1] 374 0
Other
Name [1] 374 0
NZSP
Country [1] 374 0
New Zealand
Primary sponsor type
University
Name
Auckland university of technology
Address
Private bag 92006, auckland
Country
New Zealand
Secondary sponsor category [1] 300 0
Hospital
Name [1] 300 0
Auckland city hospital,
Address [1] 300 0
Grafton rd, auckland
Country [1] 300 0
New Zealand
Secondary sponsor category [2] 301 0
University
Name [2] 301 0
University of melbourne
Address [2] 301 0
faculty of medicine dentistry and health
Country [2] 301 0
Australia

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35219 0
Address 35219 0
Country 35219 0
Phone 35219 0
Fax 35219 0
Email 35219 0
Contact person for public queries
Name 9395 0
Julie Reeve
Address 9395 0
School of Physiotherapy
Auckland University of Technology
Auckland
Country 9395 0
New Zealand
Phone 9395 0
+64 9 9219999 ext 7085
Fax 9395 0
Email 9395 0
[email protected]
Contact person for scientific queries
Name 323 0
Julie Reeve
Address 323 0
School of Physiotherapy
Auckland University of Technology
Auckland
Country 323 0
New Zealand
Phone 323 0
+64 9 9219999 ext 7085
Fax 323 0
Email 323 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Reeve, J. C., Nicol, K., Stiller, K., McPherson, K... [More Details]
Study results articleYes Reeve, J., Stiller, K., Nicol, K., McPherson, K. M... [More Details]

Documents added automatically
No additional documents have been identified.