Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000076875
Ethics application status
Approved
Date submitted
16/01/2012
Date registered
16/01/2012
Date last updated
16/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Exercise Training to Improve Physical Functioning and Exercise Adoption in Lung Cancer Survivors: a Randomized Controlled Trial
Scientific title
Exercise Training to Improve Physical Functioning and Exercise Adoption in Lung Cancer Survivors: a Randomized Controlled Trial
Secondary ID [1] 279727 0
Nil
Universal Trial Number (UTN)
U1111-1127-1611
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 285566 0
Condition category
Condition code
Cancer 285763 285763 0 0
Lung - Non small cell
Cancer 285776 285776 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Exercise Group:
Participants randomized to the exercise arm will receive 12-weeks of supervised and home-based exercise
training. For the first 8-weeks, supervised training will take place twice weekly. The supervised exercise will take approximately 60 minutes, and will include resistance training (6 exercises; 12-6 RM), and aerobic training (walking; 60-85% HRmax). Home-based walking will be progressively prescribed during this time (from 1-3 times a week). For the final month participants will undergo one supervised exercise training session, and one home-based resistance training session, as well as home-based walking up to three times per week. The exercise program will be individually prescribed relative to the individuals health and fitness, but will be based on a standard program.
Intervention code [1] 284025 0
Lifestyle
Intervention code [2] 284035 0
Rehabilitation
Comparator / control treatment
Control Group
Participants in the usual care control group will be asked not to change their current exercise behavior. Following the 3 month assessment, the control group participants will be offered the home-based exercise logbook, a supervised educational training session, and home-based exercise equipment.
Control group
Active

Outcomes
Primary outcome [1] 286285 0
Physical Functioning measured by the six-minute walk test
Timepoint [1] 286285 0
Baseline, 3 months
Secondary outcome [1] 295521 0
Muscular strength will be assessed by 1 repetition maximum (RM) for upper body (chest press and seated
row) and lower body (leg press).
Timepoint [1] 295521 0
Baseline, 3 months
Secondary outcome [2] 295522 0
Additional measures of physical functioning repeated chair rise; stair climb; timed up-and-go, balance
Timepoint [2] 295522 0
Baseline, 3 months
Secondary outcome [3] 295523 0
Health-related quality of life, measured using: The Medical Outcomes Study Short-Form 36 and the Functional Assessment of Cancer Therapy - Lung Cancer
Timepoint [3] 295523 0
Baseline, 3-months, and 6-months follow-up
Secondary outcome [4] 295524 0
Fatigue using the FACIT-Fatigue scale
Timepoint [4] 295524 0
Baseline, 3-months, and 6-months follow-up
Secondary outcome [5] 295525 0
Physical Activity: Will be assessed by the Godin Leisure-Time Questionnaire, and using triaxial accelerometry
Timepoint [5] 295525 0
Baseline, 3 months, and 6 months follow-up
Secondary outcome [6] 295526 0
Anxiety and Depression: The Brief Symptom Inventory-18
Timepoint [6] 295526 0
Baseline, 3 months, and 6 month follow-up
Secondary outcome [7] 295527 0
Sleep quality, measured by the Pittsburgh Sleep Quality Index
Timepoint [7] 295527 0
baseline, 3 months, and 6 month follow-up
Secondary outcome [8] 295528 0
Muscle Density: Peripheral Quantitative Computed Tomography (pQCT) of the lower limbs
Timepoint [8] 295528 0
baseline, 3 months
Secondary outcome [9] 295529 0
Physical Activity Motivation: Theory of Planned Behaviour constructs (affective and instrumental attitude, injunctive and descriptive norm, self-efficacy, perceived behavioural control, intention, and planning) will be assessed using a standard TPB Questionnaire.
Timepoint [9] 295529 0
baseline, 3 months, and 6 month follow-up
Secondary outcome [10] 295530 0
Program satisfaction will be evaluated by questionnaire written specifically for this study
Timepoint [10] 295530 0
3 months, and 6 month follow-up
Secondary outcome [11] 295531 0
Shortness of breath measure by the cancer dyspnea scale and the MRC Dyspnea scale
Timepoint [11] 295531 0
Baseline, 3 months, and 6-month follow-up

Eligibility
Key inclusion criteria
Confirmed stage I-IIIB non-small cell lung cancer or
limited stage small cell lung cancer and not currently on treatment for cancer.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participating in regular exercise (performing 150 minutes of
aerobic exercise and resistance exercise 2 days/week) within the past 3 months.
Any musculoskeletal, neurological, or cardiovascular disorder that could inhibit exercise or put them at risk of injury or illness.
Metastatic disease or presence of bone metastases.

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)
Written informed consent will be required prior to any testing or randomisation. Assignments will be placed in sealed opaque envelopes and designated colours will be assigned for each group. The subject will open these envelopes after completion of all baseline testing. Subjects who dropout prior to completion of baseline testing will not be randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are randomised after the baseline assessment has been completed to: 1. Exercise training or 2. Usual care control. Randomisation is at the level of the individual patient. Patients will be stratified on gender
(male/female) and age (<55 / greater than or equal to 55) The list will be generated and maintained by a research assistant not otherwise involved in the study. The sequential treatment assignments are based on a computer-generated randomisation scheme (by using the Web site www.randomization.com set up by Dr Gerard E. Dallal).
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
15/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284506 0
University
Name [1] 284506 0
Edith Cowan University Early Career Researcher Grant Scheme
Country [1] 284506 0
Australia
Primary sponsor type
University
Name
Edith Cowan University
Address
270 Joondalup Drive
Joondalup WA 6027
Country
Australia
Secondary sponsor category [1] 283437 0
Individual
Name [1] 283437 0
Dr. Carolyn McIntyre
Address [1] 283437 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup, WA
6027
Country [1] 283437 0
Australia
Other collaborator category [1] 260442 0
Individual
Name [1] 260442 0
A/Prof Daniel Galvao
Address [1] 260442 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country [1] 260442 0
Australia
Other collaborator category [2] 260443 0
Individual
Name [2] 260443 0
Prof Robert Newton
Address [2] 260443 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup, WA
6027
Country [2] 260443 0
Australia
Other collaborator category [3] 260446 0
Individual
Name [3] 260446 0
Nigel Spry
Address [3] 260446 0
Clinical and Adjunct Staff (Medicine and Pharmacology, SCGH)
The University of Western Australia (M503)
35 Stirling Highway
CRAWLEY WA 6009
Country [3] 260446 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286488 0
Edith Cowan University Human Research Ethics Committee
Ethics committee address [1] 286488 0
Ethics committee country [1] 286488 0
Australia
Date submitted for ethics approval [1] 286488 0
Approval date [1] 286488 0
30/11/2011
Ethics approval number [1] 286488 0
7421
Ethics committee name [2] 286489 0
DEPARTMENT OF HEALTH WESTERN AUSTRALIA HUMAN RESEARCH ETHICS COMMITTEE
Ethics committee address [2] 286489 0
Ethics committee country [2] 286489 0
Australia
Date submitted for ethics approval [2] 286489 0
29/11/2011
Approval date [2] 286489 0
Ethics approval number [2] 286489 0

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

Contacts
Principal investigator
Name 33630 0
Address 33630 0
Country 33630 0
Phone 33630 0
Fax 33630 0
Email 33630 0
Contact person for public queries
Name 16877 0
Dr. Carolyn McIntyre
Address 16877 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 16877 0
Australia
Phone 16877 0
+61 08 6304 3987
Fax 16877 0
+61 8 6304 2499
Email 16877 0
[email protected]
Contact person for scientific queries
Name 7805 0
Dr. Carolyn McIntyre
Address 7805 0
ECU Health and Wellness Institute
270 Joondalup Drive
Joondalup WA 6027
Country 7805 0
Australia
Phone 7805 0
+61 8 6304 3987
Fax 7805 0
+61 8 6304 2499
Email 7805 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
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