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Trial registered on ANZCTR


Registration number
ACTRN12623001049662
Ethics application status
Approved
Date submitted
9/08/2023
Date registered
27/09/2023
Date last updated
15/09/2024
Date data sharing statement initially provided
27/09/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise Study for Leukemia Survivors
Scientific title
Effect of Exercise on Cardiorespiratory Fitness in Post Remission Leukemia
Secondary ID [1] 310319 0
Nil
Universal Trial Number (UTN)
Trial acronym
IMPROVE
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukaemia 330770 0
Acute Lymphoblastic Leukaemia
 331038 0
Condition category
Condition code
Cancer 327608 327608 0 0
Leukaemia - Acute leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical activity intervention will consist of an individualised structured exercise program that combines both aerobic and resistance-based exercises.

The intervention will be delivered in a flexible manner by combining face-to-face exercise sessions (conducted at the Baker Institute gym) and via telehealth applications (such as Physitrack). All participants will be provided with an individualised training program. The Baker gym is fully equipped to facilitate a range of aerobic and resistance based exercise training. The exercise sessions will be tailored to the participant’s specific fitness levels and ability by the project’s exercise physiologist and adjustments to the training program will be made in accordance to the participant’s progression. The exercise intervention will consist of three, 45-60 minute sessions of structured exercise per week, containing both aerobic and resistance based exercise components (including a warm-up and cool-down period), for 12 weeks. Each session at the Baker gym will be supervised by an exercise physiologist.
If it is not feasible to conduct a session at the gym, home-based exercise sessions will be prescribed and supervised using the Physitrack telehealth application, which allows the exercise physiologist to instruct sessions online to participants using their mobile device. For any home-based exercise sessions, equipment will be provided to the participants (e.g. cycle ergometer, adjustable dumbbells and resistance bands) unless the participant already has access to a gym offsite. Information regarding exercise adherence, total exercise duration, intensity and weight progression will also be collected.

Each participant will be prescribed an individualized exercise program informed by the results of their baseline exercise testing. Participants will be prescribed 3 exercise sessions per week consisting of 2 moderate intensity continuous aerobic sessions and 1 high intensity training session. They will also do 2 resistance training sessions per week. Participants will be given a wearable device which is used to monitor heart rate during sessions that will be useful in prescribing exercises.

The aerobic component of the program will consist of both continuous steady state and interval-based training. Interval sessions will be performed on a cycle ergometer, whilst the continuous training will be performed on an upright cycle, treadmill and/or elliptical trainer based on participant preference. A combination of steady state and interval training will be used to provide varied forms of physiological perturbation to the different components of the oxygen cascade. This is a training paradigm that is commonly-practiced in endurance athletes, and is receiving growing interest in cancer populations due to the ‘multiple hits’ induced by cancer treatments.(Mezzani, Grassi et al. 2013, Hornsby, Douglas et al. 2014)Exercise intensity will be individualised from each participant’s heart rate (HR) and workload corresponding to their ventilatory threshold (VT) and VO2peak from the baseline CPET. Aerobic exercise intensity will be monitored by rating of perceived exertion (RPE) and HR. The duration of continuous exercise will be progressively increased over the initial 6 weeks of the intervention, from 30 to 40 minutes. Thereafter the intensity of each of these sessions will be increased from 60 to 70% of baseline VO2 max, from week 6 to week 12 of the intervention. All sessions will include a 5-minute aerobic warm up and cool-down. Interval sessions will begin from week 2, and will consist of four intervals of 2 minutes at a HR 5-10 beats/min above VT during weeks 2-3, and progressing to 3-minutes at a HR 5-10 beats/min above VT during weeks 4-6. For the final 6 weeks of the program, participants will perform high-intensity intervals at 85-95% HR peak, with the interval duration lasting for 3-minutes in weeks 7-9, and progressing to 4-minutes in weeks 10-12. All intervals will be interspersed with 3-minutes of light-intensity active recovery throughout the program.

The resistance training component will be performed 2x/wk alongside two of the aerobic training sessions. Sessions will consist of 6-8 exercises targeting major muscle groups (including 1-3 lower body exercises, 3-4 upper body exercises and 1 core body exercise). Each resistance training session will take approx. 20-30 mins and involve a mix of body weight and weighted exercises using dumbbells, resistance bands and machine weights depending on the equipment available to participants. For each exercise, two sets of 8-15 repetitions will be performed, with the goal of progressing weights over the 12-week intervention. Adherence and progression will be documented by the exercise physiologist.

Hornsby, W. E., P. S. Douglas, M. J. West, A. A. Kenjale, A. R. Lane, E. R. Schwitzer, K. A. Ray, J. E. Herndon, 2nd, A. Coan, A. Gutierrez, K. P. Hornsby, E. Hamilton, L. G. Wilke, G. G. Kimmick, J. M. Peppercorn and L. W. Jones (2014). "Safety and efficacy of aerobic training in operable breast cancer patients receiving neoadjuvant chemotherapy: a phase II randomized trial." Acta Oncol 53(1): 65-74.
Mezzani, A., B. Grassi, A. M. Jones, A. Giordano, U. Corra, S. Porcelli, S. Della Bella, A. Taddeo and P. Giannuzzi (2013). "Speeding of pulmonary VO2 on-kinetics by light-to-moderate-intensity aerobic exercise training in chronic heart failure: clinical and pathophysiological correlates." Int J Cardiol 167(5): 2189-2195.
Intervention code [1] 326576 0
Prevention
Intervention code [2] 326579 0
Behaviour
Intervention code [3] 326580 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335445 0
Submaximal and a ramp protocol peak exercise test will be performed on a bicycle ergometer with the help of the Vyntus CPX metabolic cart to calculate the peak oxygen uptake.
Timepoint [1] 335445 0
Baseline and 12 week follow-up
Secondary outcome [1] 424580 0
Quality of life will be measured using the validated Eq-5D ,FACT-Leu and PSQI.
Timepoint [1] 424580 0
Baseline and 12 week follow-up
Secondary outcome [2] 424581 0
Quality of mental health will be assessed using DASS21
Timepoint [2] 424581 0
Baseline and 12 week follow-up
Secondary outcome [3] 424584 0
Physical activity levels will be assessed using the IPAQ questionnaire.
Timepoint [3] 424584 0
Baseline and 12 week follow-up
Secondary outcome [4] 425671 0
Fatigue will be assessed using the FACIT-fatigue scale.
Timepoint [4] 425671 0
Baseline and 12 week follow-up
Secondary outcome [5] 425672 0
Functional independence will be defined as VO2 peak of greater than 18mL/kg/min
Timepoint [5] 425672 0
Baseline and 12 week follow-up

Eligibility
Key inclusion criteria
Adults with acute leukaemia in complete morphologic remission (CR or CRi)following intensive chemotherapy.
Age greater than or equal to 18 years.
Ability to provide informed consent.
Consent to ALLG NBCR and Alfred Tissue Bank (required for biospecimen collection).
Willingness to attend scheduled appointments and undertake scheduled assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not being treated with curative intent.
Subjects for whom, in the opinion of the investigator, participation would pose an unnecessary risk to participant or study.
Concurrent malignancy requiring chemotherapy or major illness which, in the opinion of the investigator, may to confound assessments.

Study design
Purpose of the study
Prevention
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
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The degree of change in VO2 peak from baseline to post intervention will be analysed via paired student t test. Simple linear and multiple linear regression will be used to explore which factors most impacted the degree of change in VO2 peak.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
26/03/2021
Date of last participant enrolment
Anticipated
31/07/2024
Actual
14/08/2024
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314347 0
Charities/Societies/Foundations
Name [1] 314347 0
The Baker Heart and Diabetes Institute
Country [1] 314347 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Baker Heart and Diabetes Institute
Address
75 Commercial Road, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 316474 0
None
Name [1] 316474 0
Address [1] 316474 0
Country [1] 316474 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313444 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 313444 0
Level 5/553,St Kilda Road, Melbourne, VIC 3004
Ethics committee country [1] 313444 0
Australia
Date submitted for ethics approval [1] 313444 0
05/02/2021
Approval date [1] 313444 0
11/02/2021
Ethics approval number [1] 313444 0

Summary
Brief summary
Purpose of the study:
The aim of this study is to investigate whether a structured physical activity program undertaken following chemotherapy can improve physical fitness and heart function in acute leukaemia patients. The results of this study will be used to guide future care for acute leukaemia patients.
Who is it for?
You may be eligible to join this study if you are aged 18 years and above and can exercise at the time of enrolment.

Study details:
Participants will undergo a series of assessments prior to the beginning of the study and again at 12 weeks later. Participants will perform three exercise bouts per week which will be supervised by the study physiotherapist or exercise physiologist. They will also be given a wearable device which is used to monitor heart rate which can then be used to prescribe exercises. These study activities will be included along with the normal care from the doctors.

It is hoped that this study will help determine whether exercise can assist in increasing the physical fitness and quality of life of adults with leukaemia.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 128182 0
A/Prof Erin Howden
Address 128182 0
Level 4,Alfred Centre-Human Integrative Physiology Laboratory,Baker Heart and Diabetes Institute,99 Commercial Road, Melbourne VIC 3004
Country 128182 0
Australia
Phone 128182 0
+61 3 8532 1861
Fax 128182 0
+61 3 8532 1899
Email 128182 0
[email protected]
Contact person for public queries
Name 128183 0
Erin Howden
Address 128183 0
Level 4,Alfred Centre-Human Integrative Physiology Laboratory,Baker Heart and Diabetes Institute,99 Commercial Road, Melbourne VIC 3004
Country 128183 0
Australia
Phone 128183 0
+61 3 8532 1861
Fax 128183 0
+61 3 8532 1899
Email 128183 0
[email protected]
Contact person for scientific queries
Name 128184 0
Erin Howden
Address 128184 0
Level 4,Alfred Centre-Human Integrative Physiology Laboratory,Baker Heart and Diabetes Institute,99 Commercial Road, Melbourne VIC 3004
Country 128184 0
Australia
Phone 128184 0
+61 3 8532 1861
Fax 128184 0
+61 3 8532 1899
Email 128184 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will only be shared. This includes individual participant data of published results only. Requests for data will be assessed as per each individual request by the PI and will be released at the PI's discretion
When will data be available (start and end dates)?
Data will be available upon the initial date of publication of the findings on a request basis. There will be no stated end date of data availability as requests will be assessed individually by the PI.
Available to whom?
Data will be available to any researcher or clinician that submits a reasonable request to the PI of the study.
Available for what types of analyses?
De-identified data will be available for analyses. No specific analyses criteria will be used for this study, however all data requests will be reviewed by the PI and data will be released on an individual request basis.
How or where can data be obtained?
Requests for data, analytic methods, and study materials should be sent to the PI who will consider all reasonable requests.
PI - A/Prof Erin Howden
Email: [email protected]


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.