Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000130268
Ethics application status
Not yet submitted
Date submitted
22/01/2009
Date registered
23/02/2009
Date last updated
23/02/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative and postoperative physiotherapy versus postoperative physiotherapy alone following elective upper abdominal surgery – A randomised trial.
Scientific title
A comparison of preoperative and postoperative physiotherapy versus postoperative physiotherapy alone for patients undergoing elective upper abdominal surgery. A randomised controlled trial investigating the effects on patient anxiety, postoperative pulmonary complications and overall physiotherapy contact time.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Elective upper abdominal surgery 4219 0
Condition category
Condition code
Surgery 4437 4437 0 0
Other surgery
Physical Medicine / Rehabilitation 4438 4438 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients randomised to the treatment group will receive postoperative physiotherapy. This includes tansferring out of bed on the first postoperative day with the assistance of the physiotherapist, as well as the completion of specifically targeted breathing, lower limb exercises and graduated walking. These patients will continue to receive physiotherapy, aimed at progressing the patient's mobility and respiratory function, until it is deemed no longer necessary by the treating physiotherapist. The frequency and duration of the postoperative physiotherapy sessions will be at the discretion of the treating physiotherapist, as individual patients may require more or less physiotherapy input depending on their rate of progression. Patients in the treatment group will also receive a single session of physiotherapy preoperatively of 30-45 minutes duration (45 minutes will be allowed for patients requiring an interpreter).This preoperative session will take place approximately 1-2 weeks prior to surgery. During this preoperative session, the physiotherapist will collect information including the patient’s past medical history, social history and details of their pre-morbid physical functioning. The patients will be educated regarding their surgery, the complications often associated with surgery that may be reduced by participating in physiotherapy, and the rationale for postoperative physiotherapy. They will be given the opportunity to practise the specific breathing and lower limb exercises to be performed postoperatively and to ask the physiotherapist any questions.
Intervention code [1] 3935 0
Prevention
Intervention code [2] 3936 0
Treatment: Surgery
Intervention code [3] 3937 0
Rehabilitation
Comparator / control treatment
Postoperative physiotherapy, which is standard treatment. The patient receives physiotherapy commencing on the first postoperative day, which continues on subsequent days until deemed no longer necessary by the treating physiotherapist. The postoperative physiotherapy program includes transferring out of bed on the first postoperative day with the assistance of the physiotherapist, specifically tailored breathing and lower limb exercises, as well as graduated walking and stair climbing as appropriate. The frequency and duration of the postoperative physiotherapy sessions will be at the discretion of the treating physiotherapist, as individual patients may require more or less physiotherapy input depending on their rate of progression.
Control group
Active

Outcomes
Primary outcome [1] 5317 0
Patient anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS). Patients in both groups will be assisted to complete the questionnaire by a research assistant (blinded as to group allocation). Only the anxiety sub-scale of the HADS will be used. It is a self-report rating scale of 7 items (score 0-3 for each item).
Timepoint [1] 5317 0
Immediately prior to the physiotherapist assisting the patient out of bed on the first postoperative day.
Primary outcome [2] 5318 0
The incidence of postoperative pulmonary complications (PPC) will be measured using the following criteria:
A patient will be deemed to have developed a PPC if 2 or more of the following criteria is present on >/= 2 consecutive days within the first 6 postoperative days: (1) Cough or sputum production, which is different from preoperative assessment; (2) Abnormal breath sounds on auscultation; (3) Temperature >/= 38degrees Celsius (4) Chest radiograph demonstrating atelectasis or new infiltrate; and (5) Physician documentation of atelectasis or pneumonia. [adapted by Brooks-Brunn (1997) from Seymour and Pringle (1983)]
Timepoint [2] 5318 0
Presence of the above criteria will be assessed by the treating physiotherapist every day for the first 6 postoperative days.
Primary outcome [3] 5319 0
Overall physiotherapy contact time will be calculated using routinely entered physiotherapy statistics. At The Northern Hospital, statistics are entered into the "Healthpower" computer program. For patients in the intervention group, the preoperative physiotherapy session time will be added to the total postoperative physiotherapy session time.
Timepoint [3] 5319 0
Calculations of overall physiotherapy contact time will be made once the patient has been discharged from The Northern Hospital.
Secondary outcome [1] 8948 0
Each patient will be assessed as either low or high risk of developing a PPC by an independent researcher (blinded to group allocation), using the Postoperative Pneumonia Risk Index (Arozullah et al 2001).
Timepoint [1] 8948 0
The Postoperative Pneumonia Risk Index will be completed by the blinded researcher on the first postoperative day.

Eligibility
Key inclusion criteria
Patients undergoing elective upper abdominal surgery presenting to the Preadmission Clinic at The Northern Hospital.
Patients 18 years and older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Failure to consent; and
Score < 7 on the Abbreviated Mental Test Score (AMTS)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4401 0
Hospital
Name [1] 4401 0
Northern Health
Country [1] 4401 0
Australia
Primary sponsor type
Hospital
Name
Northern Health
Address
The Northern Hospital,
185 Cooper Street,
Epping, Victoria, 3076
Country
Australia
Secondary sponsor category [1] 3960 0
None
Name [1] 3960 0
Address [1] 3960 0
Country [1] 3960 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6449 0
Northern Health Human Research and Ethics Committee
Ethics committee address [1] 6449 0
Ethics committee country [1] 6449 0
Australia
Date submitted for ethics approval [1] 6449 0
20/02/2009
Approval date [1] 6449 0
Ethics approval number [1] 6449 0

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

Contacts
Principal investigator
Name 29205 0
Address 29205 0
Country 29205 0
Phone 29205 0
Fax 29205 0
Email 29205 0
Contact person for public queries
Name 12452 0
Sarah Threlfall
Address 12452 0
Bundoora Extended Care Centre,
1231 Plenty Road
Bundoora, Victoria, 3148
Country 12452 0
Australia
Phone 12452 0
+61 3 9495 3382
Fax 12452 0
Email 12452 0
[email protected]
Contact person for scientific queries
Name 3380 0
Sarah Threlfall
Address 3380 0
Bundoora Extended Care Centre,
1231 Plenty Road
Bundoora, Victoria, 3148
Country 3380 0
Australia
Phone 3380 0
+61 3 9495 3382
Fax 3380 0
Email 3380 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
No additional documents have been identified.