Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001550190
Ethics application status
Approved
Date submitted
20/09/2019
Date registered
11/11/2019
Date last updated
11/11/2019
Date data sharing statement initially provided
11/11/2019
Date results provided
11/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Preoperative exercise intervention for individuals with early stage non-small cell lung cancer undergoing lung surgery
Scientific title
Safety and feasibility of Prehabilitation for individuals having lung cancer surgery: a pilot randomised control trial
Secondary ID [1] 299364 0
nil known
Universal Trial Number (UTN)
U1111-1240-7449
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suspected stage I-IIIA non-small cell lung cancer (NSCLC) 314521 0
Condition category
Condition code
Cancer 312867 312867 0 0
Lung - Non small cell
Physical Medicine / Rehabilitation 313060 313060 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention (Prehabilitation group):
Participants allocated to the intervention group will receive a prehabilitation program prior to surgery. This includes resistance (free weights/ resistance band exercises for upper limb and lower limb) and aerobic training (walking, bike or treadmill) of moderate intensity designed and supervised by an experienced thoracic physiotherapist using exercise training principles. For between 1-4 weeks preoperatively, intervention participants will receive;
- hospital based supervised gym sessions (3x week, each 45 min duration), one-on-one
- individualised home exercise program on days not attending hospital-based gym sessions
and education regarding a home exercise program (exercise booklet + resistance exercise band designed specifically for this study)
- 1-2 home visits
- weekly phone calls to encourage home adherence
- education: including lay information about lung cancer, the importance of staying active, diet and symptom control (e.g. breathlessness) given verbally in the initial consultation by the trial physiotherapist. This education will be provided once on the initial consultation, duration of the session will be approximately 15 minutes.
- an exercise diary to record weekly exercise sessions

The intervention will be individualised such that participants who opt not to attend the hospital gym sessions will be prescribed an exercise program (minimum 3x/week, 45min duration each session) to complete in their home with telephone and home visit follow-up. Participants will be given a stationary bike to use whilst exercising at home (if they do not already have one). Exercise intensity will be tailored to the individual and will utilise the BORG scale to monitor/progress as appropriate.

The last exercise session for the intervention group will occur in the days preceding the surgery and may differ for each participant (dependant on the day of surgery). Exercise sessions are flexible in that they can be completed on subsequent or alternate days, at the discretion of the participant.

Participants will receive standard post-operative care consisting of a thoracic surgery clinical pathway.
Intervention code [1] 315629 0
Rehabilitation
Intervention code [2] 315743 0
Treatment: Other
Comparator / control treatment
Control (no prehabilitation group):
Participants allocated to the control group will not undergo prehabilitation prior to surgery and instead will receive standard care (no exercise or preoperative physiotherapy).
Participants will receive standard post-operative care consisting of a thoracic surgery clinical pathway.
Control group
Active

Outcomes
Primary outcome [1] 321477 0
Composite primary outcome: Feasibility assessed as the number screened, number consenting (number of refusals), patient reported satisfaction with exercise program using semi-structured qualitative interviews (structured telephone interview of varying duration), adherence to program (number of gym/home exercise and home walking sessions completed out of the total available)
Timepoint [1] 321477 0
At conclusion of the prehabilitation program
Primary outcome [2] 321478 0
- Safety: study specific questionnaire documenting number of minor and major adverse events (fall/collapse, participant becomes acutely unwell, significant haemodynamic changes, new onset of chest pain, SpO2 < 85% or 10% drop below resting SpO2, respiratory rate > 35 breaths/min, participant temperature > 38 degrees) as reported by the trial researchers , length of time between surgical consult to recruitment and length of prehabilitation (days)
Timepoint [2] 321478 0
At conclusion of the prehabilitation program
Secondary outcome [1] 375067 0
Number and type of postoperative pulmonary complications (PPC) measured via the Melbourne Group Scale (MGS) version 2
Timepoint [1] 375067 0
Hospital discharge
Secondary outcome [2] 375068 0
Functional exercise capacity: measured via Incremental Shuttle Walk Test (ISWT), an externally paced walking test measuring exercise tolerance
Timepoint [2] 375068 0
Baseline Preoperative (after prehabilitation) Hospital Discharge 30-days post surgery
Secondary outcome [3] 375069 0
Muscle strength: measured via a hand-held dynamometer - a simple, quick measurement of muscle strength. Areas tested include; hand grip, rotation cuff strength (arm abduction) and quadriceps strength (knee extension) Composite secondary outcome
Timepoint [3] 375069 0
Baseline Preoperative (after prehabilitation) Hospital discharge 30 days post surgery
Secondary outcome [4] 375070 0
Self reported Physical Activity Levels - measured via questionnaire - International Physical Activity Questionnaire (IPAQ)
Timepoint [4] 375070 0
Baseline 30-days post surgery
Secondary outcome [5] 375071 0
Health-related Quality of Life - measured via questionnaire - European Organisation for the Research and Treatment of Cancer Questionnaire lung cancer specific measurement tool (EORTC QLQ-C30-LC13)
Timepoint [5] 375071 0
Baseline 30-days post surgery
Secondary outcome [6] 375072 0
Mood - measured via questionnaire - Hospital Anxiety and Depression Questionnaire (HADS)
Timepoint [6] 375072 0
Baseline Preoperatively (after prehabilitation) Hospital discharge 30-days post surgery
Secondary outcome [7] 375573 0
Postoperative Length of Stay (LOS) - measured via data linkage to medical records
Timepoint [7] 375573 0
Hospital discharge

Eligibility
Key inclusion criteria
Inclusion criteria:
- suspected stage I-IIIA NSCLC presenting for surgical consult
- age > 18 years
- functional exercise capacity < 70% predicted (6MWT) (recruiting those who are most likely to benefit
- primary treating surgeon approval
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:
- unstable psychiatric/cognitive disorder
- major comorbidities preventing participation in the exercise
- unable to give informed consent
- non-english speaking

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 informed consent and baseline assessment, participants will be randomised 1:1 to either the intervention or control group. Randomisation will be remotely and independently performed using random number generation and stratified group allocation will be concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table created by computer software (computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The analysis will be by intention-to-treat principles: all randomised patients will have data collection until the end of the study or they withdraw, and all patients will be included in the analyses. Baseline characteristics will be summarised by group and reported as mean (SD) for normally distributed data, median (IQR) for non-normally distributed data or as proportions. Analysis of the primary outcome, feasibility and timing of the prehabilitation program, will involve reporting of the proportion of participants screened who consented, the proportion of exercise sessions prescribed which were performed, the number of minor or major adverse events, length of time to recruitment and length of prehabilitation.
Data from semi-structured interviews will be collated and summarised. Qualitative data will be transcribed verbatim, entered into a qualitative data management software program and thematic analyses undertaken to identify: program satisfaction, key barriers and facilitators of physical activity and factors impacting adherence over time.
Analyses of secondary outcomes immediately prior to surgery will be undertaken by two group comparison using either parametric or non-parametric (or bootstrapping) methods depending on assumptions of data. Analysis of the outcomes involving 4 time points will use linear mixed models in which the subject is a random effect and treatment group/time are fixed effects. Alpha will be set at 0.05 for all analyses and all tests will be two-sided.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
31/07/2015
Date of last participant enrolment
Anticipated
Actual
28/12/2018
Date of last data collection
Anticipated
Actual
31/01/2019
Sample size
Target
40
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14846 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 28099 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 303882 0
Hospital
Name [1] 303882 0
St Vincents Hospital Melbourne
Country [1] 303882 0
Australia
Primary sponsor type
Hospital
Name
St Vincents Hospital Melbourne
Address
Physiotherapy Department
41 Victoria Parade
Fitzroy, VIC 3065
Country
Australia
Secondary sponsor category [1] 304022 0
University
Name [1] 304022 0
The University of Melbourne
Address [1] 304022 0
Faculty of Medicine, Dentistry & Health Sciences Physiotherapy Level 7, Alan Gilbert Building 161 Barry Street Victoria, 3010
Country [1] 304022 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304386 0
St Vincents Hospital Melbourne Human Research Ethics Commitee
Ethics committee address [1] 304386 0
Ethics committee country [1] 304386 0
Australia
Date submitted for ethics approval [1] 304386 0
Approval date [1] 304386 0
04/05/2015
Ethics approval number [1] 304386 0
HREC-A 022/15

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

Contacts
Principal investigator
Name 96774 0
Mrs Anna Shukla
Address 96774 0
St Vincents Hospital Melbourne 41 Victoria Parade Fitzroy, VIC 3065
Country 96774 0
Australia
Phone 96774 0
+613 92312211
Fax 96774 0
Email 96774 0
[email protected]
Contact person for public queries
Name 96775 0
Anna Shukla
Address 96775 0
St Vincents Hospital Melbourne 41 Victoria Parade Fitzroy, VIC 3065
Country 96775 0
Australia
Phone 96775 0
+613 92312211
Fax 96775 0
Email 96775 0
[email protected]
Contact person for scientific queries
Name 96776 0
Anna Shukla
Address 96776 0
St Vincents Hospital Melbourne 41 Victoria Parade Fitzroy, VIC 3065
Country 96776 0
Australia
Phone 96776 0
+613 92312211
Fax 96776 0
Email 96776 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Access to data will be assessed on a case-by-case basis

Conditions for requesting access:
• -

What individual participant data might be shared?
• Individual participant data underlying published results

What types of analyses could be done with individual participant data?
• for any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• Access to data can be obtained by connecting the principle investigator
(email: [email protected])

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo Twenty-four patients were included in the pilot - ... [More Details]

Documents added automatically
No additional documents have been identified.