Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000858897
Ethics application status
Approved
Date submitted
9/04/2021
Date registered
2/07/2021
Date last updated
4/07/2022
Date data sharing statement initially provided
2/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Feasibility and effects of an exercise program delivered before treatment commencement in people with lung cancer.
Scientific title
Feasibility and effects of an exercise program delivered before treatment commencement in people with lung cancer.
Secondary ID [1] 302523 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Inoperable lung Cancer 319391 0
Condition category
Condition code
Cancer 317357 317357 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The prehabilitation exercise program will be delivered during the weeks participants will be awaiting medical treatment commencement. It is anticipated that the duration of the program will be between 4 and 8 weeks based on current waiting time for treatment commencement (6 weeks on average). The supervised sessions will be delivered at Fiona Stanley Hospital (FSH) or at a Community Physiotherapy Service site (e.g. Melville and Rockingham), or at Rockingham General Hospital (RGH) at least twice a week.The group size will be dependant on number of participants attending on that day. Each supervised prehabilitation exercise session will last 60 minutes and comprise walking training, and resistance exercises for the upper and lower limbs. Exercise intensity and progression will be undertaken in accordance with current international pulmonary rehabilitation guidelines (Spruit MA et al, 2013; DOI: 10.1164/rccm.201309-1634ST).
The prehabilitation exercise program will be embedded in the pulmonary rehabilitation programs of the included sites.
As per in pulmonary rehabilitation, participants will also be provided with an individualised home program that includes walking and resistance exercises to complete on an additional 1 to 2 days each week during the prehabilitation program. The number of prescribed home exercise days will be determined at baseline assessment. The participant will be given a log book to capture number of home exercise sessions. As some of the resistance exercises require a resistance exercise band (theraband), the band will be provided to participants without any extra cost to them. The home exercise program will consist of a number of resistance exercises including step ups, sit to stand and wall push-ups, as well as exercises using the theraband. The duration of the home program sessions will be 30 minutes.
The initial speed for the walking training will be set at between 70% and 80% of the average speed achieved during the baseline 6-minute walk test. Resistance training for upper and lower limbs will be prescribed according to participants’ symptoms (between 4-6 on the BORG scale for dyspnoea or 12-16 on the rating of perceived exertion [RPE] scale). Progression of exercise training will also be based on participants’ symptoms. All assessments and exercise training will be conducted by a senior physiotherapist.
Intervention code [1] 320175 0
Treatment: Other
Intervention code [2] 320622 0
Lifestyle
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327070 0
Composite Primary Outcome 1 - Feasibility of the prehabilitation exercise program.

Measures to assess feasibility of the program :
- Recruitment and completion:
• Number of participants who were screened assessed by audit of study database;
• Number of participants who were recruited (i.e. provided written consent) assessed by audit of study database;
• Number of participants who withdrew (and reasons for withdrawal) assessed by audit of study database;
• Number of participants who completed the intervention period assessed by audit of study database;
• Number of participants who completed all assessments and the intervention period assessed by audit of study database;
- Adherence:
• Number of supervised sessions completed assessed by audit of study database;
• Number of home-based sessions completed assessed by audit of study database.
Timepoint [1] 327070 0
Data or feasibility (recruitment, completion and adherence) will be collected across the whole intervention period and will be assessed at the completion of the study by audit of study database.




Secondary outcome [1] 393679 0
Composite outcome: Health-related quality of life (HRQoL) (2 questionnaires):

- The FACT-L version 4 is a self-complete 36-item questionnaire. It comprises five subscales; physical well-being, social/family well-being, emotional well-being, functional well-being as well as a separate lung cancer subscale.
- The EORTC QLQ-C30 comprises 15 scales. Five scales pertain to function (i.e. physical, role, emotional, cognitive, and social), three scales pertain to symptoms (i.e. fatigue, pain, and nausea), and there is also one global measure of health status. The remaining six scales are single-item scales that assess the following symptoms; dyspnoea, appetite loss, sleep disturbance, constipation and diarrhoea, and the perceived financial impact of the disease treatment.
Timepoint [1] 393679 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).
Secondary outcome [2] 393922 0
Functional limitation resulting from dyspnoea

Functional limitation resulting from dyspnoea will be assessed by the mMRC dyspnoea scale. This simple scale comprises five statements. The participant selects the statement which best reflects their level of limitation in activities of daily life due to breathlessness. The mMRC dyspnoea scale is a valid method of categorising people with chronic lung disease in terms of their functional disability.
Timepoint [2] 393922 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).
Secondary outcome [3] 393923 0
Fatigue

Fatigue will be assessed using the FACIT-Fatigue. The FACIT-Fatigue has 13 items answered on a 5-point rating scale and is based on a 7-day recall period. Scores range between 0 and 52, with lower scores reflecting greater fatigue.
Timepoint [3] 393923 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).
Secondary outcome [4] 393924 0
Composite outcome: Peripheral muscle force (via three tests):

Isometric quadriceps and biceps force will be measured using the Lafayette Muscle Meter number 01163 (Lafayette Instrument Company, Lafayette, IN, USA). This is a handheld dynamometer that records muscle force in kilograms, pounds, or Newtons of force. Three tests of 5 seconds will be performed on each muscle-group and maximum effort will be recorded. Standardised positions and instructions will be utilised in accordance to previously described technique.

Isometric handgrip force will be measured using a hydraulic hand dynamometer (Jamar dynamometer; JA Preston Corporation; Jackson, MI, USA). Peak handgrip force will be assessed bilaterally, with the elbow at 90° of flexion and the forearm and wrist in a neutral position. Three attempts will be performed (bilaterally). Measures will be expressed in absolute values and as a percentage of the predicted value in a healthy population.

The 1-minute sit-to-stand test is a measure of functional capacity and peripheral muscle force in older adults and people with chronic lung disease. An armless chair with a height of 46 to 48 cm will be used and participants will be instructed to fold their arms across their chest and perform the stand up and sit down movement as quickly as possible for 1 minute. The test will be performed twice, with a 10 minute break between them, and the best number of sit-to-stand repetitions will be recorded as the test result.
Timepoint [4] 393924 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).
Secondary outcome [5] 393925 0
Body composition

Body composition will be measured using bioimpedance spectroscopy (ImpediMed SFB7; ImpediMed Ltd, Brisbane, Australia). The manufacturer’s standard electrode placement for the SFB7 uses a single-channel tetra-polar configuration, and measures are performed at 256 discrete frequencies from 4 to 1000 kHz. The electrode arrangement will position drive electrodes on the dorsal surface of the third metacarpal bone of the right hand and the dorsal surface of the third metatarsal bone of the right foot. The sense electrodes will be positioned at the wrist and ankle, proximal to the drive electrodes. The SFB7 will be set to record impedance measures in triplicate, with each measure one second apart. The electrodes used are Ag/AgCl Eurotrode PFR2034 disposable resting ECG tab electrodes (reference code 12774; Pirrone srl, Milan, Italy). Measures will be recorded with the participants lying supine. The main outcome measure will be fat-free mass.
Timepoint [5] 393925 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).
Secondary outcome [6] 393926 0
Exercise capacity

Exercise capacity will be evaluated using the 6-minute walk test, which will be undertaken according to a protocol based on the current recommendations. Two tests, separated by a 30-minute rest period, will be conducted and the best distance achieved (i.e. 6-minute walk distance [6MWD]) will be recorded as the test result. Data of 6MWD will be expressed in absolute values and as a percentage of the predicted value in a healthy population.
Timepoint [6] 393926 0
Timepoint 1 - Baseline - immediately after diagnosis and before the prehabilitation program
Timepoint 2 - After the prehabilitation exercise program (post prehabilitation)
Timepoint 3 - Eight weeks after commencement of medical treatment (follow up).

Eligibility
Key inclusion criteria
Inclusion criteria will comprise adults (i) with primary non-small cell lung cancer, (ii) Eastern Cooperative Organisation Group (ECOG) performance status between 0 and 2 (scales ranges between 0 and 4, with lower scores indicating better performance status); and (iii) referred to treatments other than lung resection at FSH.
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Patients with brain metastasis, acute illness or any musculoskeletal, cardiovascular (symptomatic heart disease) or neurological disorder that could inhibit performing exercise will be excluded. For those patients willing to exercise at one of the Community Physiotherapy Service sites, an additional exclusion criterion is resting peripheral oxygen saturation (SpO2) less than or equal to 91%, and SpO2 less than or equal to 85% during the 6-minute walk test. Further, participants will be required to complete questionnaires and understand instructions, which require them to be able to read and understand English. Therefore, we are specifically excluding people who have an inability to read and understand English.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analyses will be performed using SPSS® (Statistical Package for Social Sciences, version 26.0 for Windows). Categorical data will be reported as frequencies and proportions. The distribution of continuous data will be examined by graphical (frequency histograms and box plots) and statistical methods (Shapiro-Wilk test). Data will be expressed as either mean ± standard deviation (SD) or median [interquartile range]. Parametric data collected at the three time points will be analysed using repeated measures ANOVA. Non-parametric data will be analysed using the Friedman test. For all analyses, a p value < 0.05 will be considered significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
6/05/2021
Date of last participant enrolment
Anticipated
20/12/2021
Actual
21/10/2021
Date of last data collection
Anticipated
5/08/2022
Actual
11/01/2022
Sample size
Target
15
Accrual to date
Final
7
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 19054 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 33603 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 306958 0
Government body
Name [1] 306958 0
The Chief Nursing and Midwifery Office
Country [1] 306958 0
Australia
Primary sponsor type
Government body
Name
South Metropolitan Health Service
Address
11 Robin Warren Dr,
Murdoch,
WA 6150
Country
Australia
Secondary sponsor category [1] 309112 0
None
Name [1] 309112 0
Address [1] 309112 0
Country [1] 309112 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307095 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 307095 0
Ethics committee country [1] 307095 0
Australia
Date submitted for ethics approval [1] 307095 0
12/02/2021
Approval date [1] 307095 0
02/03/2021
Ethics approval number [1] 307095 0
RGS0000004374

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

Contacts
Principal investigator
Name 106014 0
Ms Kirsten Mooney
Address 106014 0
WA Cancer and Palliative Care Network, Clinical Implementation Unit,
Locked Bag 2012
Nedlands
WA 6009
Country 106014 0
Australia
Phone 106014 0
+61 08 64570855
Fax 106014 0
Email 106014 0
[email protected]
Contact person for public queries
Name 106015 0
Kirsten Mooney
Address 106015 0
WA Cancer and Palliative Care Network, Clinical Implementation Unit,
Locked Bag 2012
Nedlands
WA 6009
Country 106015 0
Australia
Phone 106015 0
+61 08 64570855
Fax 106015 0
Email 106015 0
[email protected]
Contact person for scientific queries
Name 106016 0
Kirsten Mooney
Address 106016 0
WA Cancer and Palliative Care Network, Clinical Implementation Unit,
Locked Bag 2012
Nedlands
WA 6009
Country 106016 0
Australia
Phone 106016 0
+61 08 64570855
Fax 106016 0
Email 106016 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


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.