Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001065886
Ethics application status
Approved
Date submitted
2/10/2012
Date registered
5/10/2012
Date last updated
5/10/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Postoperative physical activity: feasibility and effects on total body protein
Scientific title
In patients having pelvic colorectal surgery is a postoperative physical activity intervention feasible and what are its effects on total body protein
Secondary ID [1] 281335 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvic colorectal surgery 287558 0
Physical Activity 287570 0
Body composition 287571 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287883 287883 0 0
Physiotherapy
Surgery 287896 287896 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
From day 2 after surgery patients will undergo supervised physical activity in a ward setting. This will entail 1)walking on a treadmill to intensity determined by patient and measured by Borg scale 2) bench stepping to 15 cm or 25 cm bench height. There are 2-3 activity sessions per day with increasing duration (9-18 mins) of treadmill sessions, no. of bench steps and bench step height over the 6 days.
Intervention code [1] 285798 0
Rehabilitation
Comparator / control treatment
Current standard care on surgical wards; sitting out of bed and ad-lib mobilisation. Recorded by physical activity monitors.
Control group
Active

Outcomes
Primary outcome [1] 288100 0
Enforced mobilisation - minutes and distances walked/day + bench steps/day
Recorded by ActiReader physical activity monitor
Timepoint [1] 288100 0
Both daily and cumulative at six days
Primary outcome [2] 288112 0
Passive mobilisation
Recorded by ActiReader physical activity monitor
Timepoint [2] 288112 0
Both daily and cumulative at six days
Secondary outcome [1] 299429 0
Total body protein/muscle mass/lean body mass as measured by in vivo neutron activation analysis, whole body pottasium counting and DEXA.
Timepoint [1] 299429 0
Preoperative and Day 14

Eligibility
Key inclusion criteria
Pelvic colorectal surgery (elective) - low anterior resection, abdominoperineal resection, proctectomy/pouch reconstruction
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Incurable metastatic disease
Medical comorbidity and physical disability that precludes exercise
BMI>40
WHO performance score > 3
Complications during immediate postoperative course (Clavien grade 3b or higher)

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)
Potential participants will be approached at the time of their preoperative outpatient clinic. They will be given a Particiant Information Sheet and contacted a few days later to discuss the study further and decide whether they wish to be enrolled. Participants are randomised (allocation concealment by off-site randomisation by Macro Randomisation Module (MacroTM EDM, InferMed, London, UK) over the internet on day of surgery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
18
Accrual to date
Final
Recruitment outside Australia
Country [1] 4581 0
New Zealand
State/province [1] 4581 0

Funding & Sponsors
Funding source category [1] 286102 0
University
Name [1] 286102 0
University of Auckland
Country [1] 286102 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Surgery,
Level 12 Support Building,
Auckland City Hospital,
Park Road, Grafton,
Auckland,
1010
Country
New Zealand
Secondary sponsor category [1] 284913 0
Hospital
Name [1] 284913 0
North Shore Hospital
Address [1] 284913 0
The North Shore Hospital,
Waitemata District Health Board,
124 Shakespeare Road,
Takapuna,
Auckland City,
0622
Country [1] 284913 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288148 0
Northern X Ethics Committee, New Zealand
Ethics committee address [1] 288148 0
Ethics committee country [1] 288148 0
New Zealand
Date submitted for ethics approval [1] 288148 0
Approval date [1] 288148 0
05/04/2012
Ethics approval number [1] 288148 0
NTX/12/03/020

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

Contacts
Principal investigator
Name 34787 0
Address 34787 0
Country 34787 0
Phone 34787 0
Fax 34787 0
Email 34787 0
Contact person for public queries
Name 18034 0
Sid Trivedi
Address 18034 0
Department of Surgery,
Level 12,
Support Building,
Auckland City Hospital,
Park Road,
Grafton,
Auckland,
1010.
Country 18034 0
New Zealand
Phone 18034 0
+64212665360
Fax 18034 0
Email 18034 0
[email protected]
Contact person for scientific queries
Name 8962 0
Sid Trivedi
Address 8962 0
Department of Surgery,
Level 12,
Support Building,
Auckland City Hospital,
Park Road,
Grafton,
Auckland,
1010.
Country 8962 0
New Zealand
Phone 8962 0
+64212665360
Fax 8962 0
Email 8962 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.