Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000864921
Ethics application status
Approved
Date submitted
5/08/2011
Date registered
15/08/2011
Date last updated
9/07/2019
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Lung cancer: the role of exercise training in optimising recovery after resection
Scientific title
The role of exercise training versus usual care in optimising recovery for patients following lung cancer resection
Secondary ID [1] 262704 0
Nil
Universal Trial Number (UTN)
U1111-1123-1716
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 270409 0
Condition category
Condition code
Cancer 270553 270553 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The exercise training program will be embedded within the pulmonary rehabilitation programs currently offered by the Physiotherapy Departments at Sir Charles Gairdner Hospital and Royal Perth Hospital. The 8-week training program will consist of 60 minutes training sessions which patients will attend three times per week. Circuit training will include aerobic (walking and cycling) and resistance training (upper and lower limbs). All sessions will be fully supervised by an experienced physiotherapist.
Intervention code [1] 267048 0
Treatment: Other
Intervention code [2] 269178 0
Rehabilitation
Comparator / control treatment
No treatment (weekly phone calls over the same 8 week trial period to control for attention and usual care). Phone calls will not have the aim to encourage people to increase physical activity or to exercise. The purpose of phone calls are: (i) to have a general discussion about participants' recovery, (ii) to ask them about their physical activity levels and pain and (iii) to remind them of their upcoming appointments. Usual care will comprise prescribed medication and doctor visits.
Control group
Active

Outcomes
Primary outcome [1] 269292 0
Maximal exercise capacity, such as the peak of oxygen uptake (VO2peak) and peak work rate (Wpeak) measured during a cardiopulmonary exercise test
Timepoint [1] 269292 0
Baseline and after 8 weeks of intervention commencement
Primary outcome [2] 269293 0
Six-minute walk distance (6MWD)
Timepoint [2] 269293 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [1] 279314 0
Force-generating capacity of peripheral muscles.
Maximal isometric force-generating capacity of the quadriceps will be measured in an upright seated position using the HUMAC NORM isokinetic dynamometer (CSMi, Stoughton, MA, USA). Individuals will be asked to perform 5 maximum contractions of the quadriceps at 60 degrees of knee flexion separated by a minimum of 30 seconds. The best of the highest three contractions which do not differ 5% from each other will be recorded as the test result.
Isometric handgrip force will be measured with a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI). Peak handgrip force will be assessed at the dominant side with the elbow at 90 degrees of flexion, and the forearm and wrist in a neutral position.
Timepoint [1] 279314 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [2] 279315 0
Health-related quality of life, assessed using 3 different questionnaires (SF-36, FACT-L and the EORTC QLQ-C30)
Timepoint [2] 279315 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [3] 279316 0
Pressure-generating capacity of respiratory muscles, generated against an occluded airway (differential pressure transducer; Honeywell, Morristown, NJ, USA)
Timepoint [3] 279316 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [4] 279317 0
Feelings of anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)
Timepoint [4] 279317 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [5] 279318 0
Fatigue, assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-Fatigue)
Timepoint [5] 279318 0
Baseline and after 8 weeks of intervention commencement
Secondary outcome [6] 279319 0
Lung function, assessed with Medgraphics Elite Series DX plethysmograph
Timepoint [6] 279319 0
Baseline and after 8 weeks of intervention commencement

Eligibility
Key inclusion criteria
Patients following lobectomy for lung cancer (Stage I or II non-small cell) residents in metropolitan Perth will be eligible to participate in this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will comprise; (i) patients undergoing pneumonectomy, (ii) presence of any co-morbid condition thought to compromise patient safety during the assessments, (iii) severe musculoskeletal limitations that would impact on the exercise measures, (iv) participation in a program of supervised exercise training in the last three months and, (v) inability to understand spoken or written English.

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)
Following lobectomy (with or without adjuvant therapy) for lung cancer, patients will be randomly assigned to a group that will receive eight weeks of supervised exercise training or a group that will receive usual care, and weekly phone calls, only. Opaque envelopes will be used for allocation concealment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be generated using a randomisation table created by computer software (i.e. computerised sequence generation). The randomisation sequences will be stratified for; (i) centre of recruitment, (ii) the need (or not) for adjuvant therapy, and (iii) gender.
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
Completed
Date of first participant enrolment
Anticipated
20/10/2011
Actual
21/11/2011
Date of last participant enrolment
Anticipated
Actual
17/03/2014
Date of last data collection
Anticipated
Actual
19/05/2014
Sample size
Target
30
Accrual to date
Final
18
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 267520 0
Hospital
Name [1] 267520 0
Research Advisory committee (Sir Charles Gairdner Hospital)
Country [1] 267520 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, WA, 6102
Country
Australia
Secondary sponsor category [1] 266562 0
Hospital
Name [1] 266562 0
Sir Charles Gairdner Hospital
Address [1] 266562 0
Hospital Ave, Nedlands, WA, 6009
Country [1] 266562 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269486 0
Sir Charles Gairdner Group (SCGG) Human Research Ethics Committee (HREC)
Ethics committee address [1] 269486 0
Hospital Ave, Nedlands, WA, 6009
Ethics committee country [1] 269486 0
Australia
Date submitted for ethics approval [1] 269486 0
30/08/2011
Approval date [1] 269486 0
27/10/2011
Ethics approval number [1] 269486 0
2011-105
Ethics committee name [2] 269561 0
Royal Perth Hospital
Ethics committee address [2] 269561 0
Wellington Street, perth, WA, 6000
Ethics committee country [2] 269561 0
Australia
Date submitted for ethics approval [2] 269561 0
01/10/2011
Approval date [2] 269561 0
18/11/2011
Ethics approval number [2] 269561 0
Ethics committee name [3] 269562 0
Curtin University
Ethics committee address [3] 269562 0
GPO Box U1987, Perth, WA 6845
Ethics committee country [3] 269562 0
Australia
Date submitted for ethics approval [3] 269562 0
01/10/2011
Approval date [3] 269562 0
14/11/2011
Ethics approval number [3] 269562 0

Summary
Brief summary
This study will explore the role that supervised exercise training has in helping Stage I or II lung cancer patients to recover.

Who is it for?

You can join this study if you have previously had a lung resection (lobectomy) for lung cancer (Stage I or II non-small cell). With or without chemotherapy, and live in the metropolitan Perth area.

Trial Details

Following completion of previous treatment for lung cancer (surgery with or without chemotherapy), you will be randomised either to a group that receives 8 weeks of supervised exercise training, or usual care where you will be followed up by weekly phone calls for general discussion about your recover. Measures will be made before and after this 'intervention' period. Specifically, measures will be made of; (i) lung function, (ii) exercise capacity, (iii) disease-specific health-related quality of life, (iv) feelings of anxiety and depression, (v) peripheral muscle force (i.e. strength) and, (vi) daily physical activity.

This trial will be the first randomised controlled trial of supervised out-patient exercise training in this patient population, and look to optimise recovery for patients following lung cancer resection.
Trial website
Trial related presentations / publications
Publications:

Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: A comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9.

Cavalheri V, Jenkins S, Cecins N, Gain K, Hill K. Comparison of the six-minute walk test with a cycle-based cardiopulmonary exercise test in people following curative intent treatment for non-small cell lung cancer. Chronic Respiratory Disease, 2016 Feb;13(2):118-27.

Cavalheri V, Jenkins S, Cecins N, Phillips M, Sanders LH, Hill K. Patterns of sedentary behaviour and physical activity in people following curative intent treatment for non-small cell lung cancer. Chronic Respiratory Disease, 2016 Feb;13(1):82-5.

Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Exercise training for people following curative intent treatment for non-small cell lung cancer: A randomised controlled trial. Brazilian Journal of Physical Therapy, 2017;21(1):58-68
Public notes

Contacts
Principal investigator
Name 32925 0
Dr Vinicius Cavalheri
Address 32925 0
Dr Vinicius Cavalheri, School of Physiotherapy and Exercise Science, Curtin University
GPO BOX 1987, Perth WA, 6845
Country 32925 0
Australia
Phone 32925 0
+61 9287 6834
Fax 32925 0
Email 32925 0
[email protected]
Contact person for public queries
Name 16172 0
Dr Vinicius Cavalheri
Address 16172 0
Dr Vinicius Cavalheri, School of Physiotherapy and Exercise Science, Curtin University
GPO BOX 1987, Perth WA, 6845
Country 16172 0
Australia
Phone 16172 0
+61 8 9266 9443
Fax 16172 0
Email 16172 0
[email protected]
Contact person for scientific queries
Name 7100 0
Dr Vinicius Cavalheri
Address 7100 0
Dr Vinicius Cavalheri, School of Physiotherapy and Exercise Science, Curtin University
GPO BOX 1987, Perth WA, 6845
Country 7100 0
Australia
Phone 7100 0
+61 8 9266 9443
Fax 7100 0
Email 7100 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study was completed over 10 years ago


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.