ANZCTR - Registration

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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

27/09/2023

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]

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

Acute Lymphoblastic Leukaemia

Condition category

Condition code

Cancer

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]

Prevention

Intervention code [2]

Behaviour

Intervention code [3]

Lifestyle

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]