Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000431921
Ethics application status
Approved
Date submitted
27/04/2011
Date registered
27/04/2011
Date last updated
27/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise intervention for patients following lung resection: pilot randomised controlled trial.
Scientific title
The safety and feasibility of an exercise intervention for patients following lung resection: pilot randomised controlled trial.
Secondary ID [1] 260064 0
NA
Universal Trial Number (UTN)
U1111-1121-0408
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 265732 0
lung cancer 265736 0
Condition category
Condition code
Physical Medicine / Rehabilitation 265870 265870 0 0
Physiotherapy
Cancer 265872 265872 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise intervention.
The intervention arm in addition to standard care will receive twice daily, aerobic, resistance and stretching exercises from day one post-operative until discharge home in a group environment supervised by a physiotherapist. This program will take about 30 minutes performed twice a day, every day until discharge home.

Following discharge the intervention arm will be provided with a home based exercise program (30 minutes of walking, 10 minutes of stretches and 10 minutes of resistance exercises each day).

Following the 2 week post-operative surgeon review, participants will participate in a twice weekly, 1 hour, supervised outpatient exercise program for eight weeks.
This will consist of treadmill walking and stationary cycling (30 minutes total of walking and cycling performed at an intensity of "somewhat hard" rating), resistance exercises (individually prescribed to the participant including exercises such as resisted leg press, calf raises (with hand held weights), wall squats (with hand held weights), step ups (with hand held weights), chest press, seated row and triceps extension (with theraband)). The entire outpatient program included all exercises listed lasts for 1 hour performed twice a week.
Intervention code [1] 264481 0
Rehabilitation
Comparator / control treatment
Standard care physiotherapy following a clinical pathway and commencing the day after surgery.
Participants will sit out of bed and mobilise at least 20 meters on the first day and at least 50 meters on the second day post-operative with assistance as required. Ambulation with the physiotherapist will no longer occur when the physiotherapist assesses that the participant will no longer benefit from specific physiotherapy intervention
Control group
Active

Outcomes
Primary outcome [1] 266637 0
Safety: number of adverse events during testing or exercise training
Timepoint [1] 266637 0
Monitored during every outcome measurement and intervention session throughout the 12 week trial.
Primary outcome [2] 266638 0
Feasibility:
Recruitment rate
Consent rate
Percentage of inpatient sessions able to be delivered to intervention group
Participant attendance at outpatient sessions
Timepoint [2] 266638 0
Assessed following data completion.
Secondary outcome [1] 276120 0
Exercise capacity (6MWT)
Timepoint [1] 276120 0
Baseline (pre-operative), 2 week post-operative and 12 weeks post-operative
Secondary outcome [2] 276121 0
Health related quality of life: The European Organization for the Research and Treatment of Cancer HRQoL questionnaire (EORTC-QLQ-C30)
Timepoint [2] 276121 0
Baseline (pre-operative) and 12 weeks post-operative

Eligibility
Key inclusion criteria
Aged 18 years or older
Post lung resection for suspect or confirmed lung cancer via a thoracotomy or VATS approach
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
NESB with insufficient English language skills to complete questionnaires
Musculoskeletal co-morbidity preventing lower limb exercises (such as walking)
Severe active psychiatric or cognitive disorder
Inability to provide consent

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 eligible participants will be screened through thoracic surgery pre-admission clinic by a recruitment therapist. All recruited participants will need to provide written informed consent and undergo baseline outcome measurement prior to surgery. Simple randomisation will be undertaken using an off-site computer generated random number table and sequentially numbered sealed opaque envelopes prepared and maintained by personnel not involved in the study. For each consented participant, at 8am on the morning after surgery, the next consecutive envelope will be opened by personnel not involved in the study for group assignment and the unblinded intervention therapist will be notified of the allocation. Participants and outcomes assessors will be blinded to allocation throughout the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
off-site computer generated random number table and sequentially numbered sealed opaque envelopes prepared and maintained by personnel not involved in the study
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264956 0
Charities/Societies/Foundations
Name [1] 264956 0
Physiotherapy Research Foundation
Country [1] 264956 0
Australia
Primary sponsor type
Hospital
Name
Austin health
Address
Studley Road, Heidelberg, 3084 VIC
Country
Australia
Secondary sponsor category [1] 264054 0
University
Name [1] 264054 0
The University of Melbourne
Address [1] 264054 0
200 Berkley Street
Parkville, 3010
VIC
Country [1] 264054 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266921 0
Austin health HREC
Ethics committee address [1] 266921 0
Ethics committee country [1] 266921 0
Australia
Date submitted for ethics approval [1] 266921 0
Approval date [1] 266921 0
04/12/2008
Ethics approval number [1] 266921 0
H2008-03402

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

Contacts
Principal investigator
Name 32538 0
Address 32538 0
Country 32538 0
Phone 32538 0
Fax 32538 0
Email 32538 0
Contact person for public queries
Name 15785 0
Catherine Granger
Address 15785 0
The University of Melbourne, School of Physiotherapy
Level 1, 200 Berkley street
Parkville 3010
VIC
Country 15785 0
Australia
Phone 15785 0
+61 3 9496 5461
Fax 15785 0
Email 15785 0
[email protected]
Contact person for scientific queries
Name 6713 0
Catherine Granger
Address 6713 0
The University of Melbourne, School of Physiotherapy
Level 1, 200 Berkley street
Parkville 3010
VIC
Country 6713 0
Australia
Phone 6713 0
+61 3 9496 5461
Fax 6713 0
Email 6713 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.