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Trial registered on ANZCTR


Registration number
ACTRN12619000741189
Ethics application status
Approved
Date submitted
16/04/2019
Date registered
17/05/2019
Date last updated
17/05/2019
Date data sharing statement initially provided
17/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of physical activity on health outcomes in patients receiving allogeneic stem cell transplants
Scientific title
Effect of Physical Activity on Cardiometabolic Health in Patients receiving Allogeneic Stem Cell Transplant (The Allo-Active trial)
Secondary ID [1] 297479 0
World Cancer Research Fund International grant reference number 2018/1666
Universal Trial Number (UTN)
U1111-1229-0120
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Haematological Cancer 311690 0
Allogenic Stem Cell Transplant Patients 311691 0
Condition category
Condition code
Cancer 310317 310317 0 0
Leukaemia - Acute leukaemia
Cancer 311032 311032 0 0
Leukaemia - Chronic leukaemia
Cancer 311033 311033 0 0
Hodgkin's
Cancer 311034 311034 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 311035 311035 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 311036 311036 0 0
Myeloma
Blood 311037 311037 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physical activity intervention will consist of 2 components:
i. A program to reduce sedentary time, and
ii. A structured exercise program combining aerobic and resistance exercises.

The exercise intervention was informed by current cancer care position statements published by the Australian College of Sports Medicine and the Clinical Oncology Society of Australia (COSA) (Cormie et al., 2018; Schmitz et al., 2010).

Participants allocated to the intervention will receive individualised sedentary behaviour reduction and exercise prescription. To facilitate the delivery of the intervention and monitoring of participants all individuals will be provided a non-invasive wrist worn device to monitor their daily physical activity. The devices are compatible with smart phones (iPhone and Android). If participants do not have a smart phone, a smart phone will be provided to them to facilitate the activity monitoring.
Sedentary Time Reduction Program: Alongside and independent of the purposeful physical activity program, participants will receive hourly prompts to interrupt their sedentary time (e.g. bed rest or sitting) with light physical activity. Participants will track their activity using their wearable device and smartphone. Each hour (up to 10 times per day) participants will be prompted to perform either a light walk or a short circuit based activity break, totalling 3 minutes of activity. These types of breaks have been found to have favourable effects on markers of cardio-metabolic health (Dempsey et al., 2017).

Structured Exercise Program: An individualised and supervised exercise program will begin as soon as participants are admitted to hospital for their transplant (once an inpatient, prior to transplant). The intervention will be performed within their hospital room and participants will be provided with the necessary equipment to facilitate this. Three supervised sessions of 30-45 minutes per session will be prescribed per week for the duration of the inpatient hospital stay. Participants will complete as many of the three prescribed sessions per week as possible. The sessions will include aerobic and resistance exercise, plus warm up and cool down. The exercise workload (quantified in Watts) corresponding to the required intensity will be individualised for each participant based on their performance in the baseline cardiopulmonary exercise test. Ratings of perceived exertion (RPE) will also be used to monitor exercise intensity. For phase 2, after discharge from hospital, participants will complete two supervised exercise sessions per week and at least one-home based session. Supervised sessions will include an aerobic and resistance component, while the home-based session will be aerobic only. RPE will be used throughout this period to monitor training intensity.

Adherence to the intervention program will be assessed by researchers via a checklist that is recorded in the database.

Cormie, P., et al. (2018). Clinical Oncology Society of Australia position statement on exercise in cancer care. Medical Journal of Australia, 209(4), 184-187.

Dempsey, P. C., et al (2017). Interrupting prolonged sitting in type 2 diabetes: nocturnal persistence of improved glycaemic control. Diabetologia, 60(3), 499-507.

Schmitz, K. H., et al (2010). American College of Sports Medicine roundtable on exercise guidelines for cancer survivors. Medicine & Science in Sports & Exercise, 42(7), 1409-1426.
Intervention code [1] 313743 0
Prevention
Intervention code [2] 313744 0
Behaviour
Intervention code [3] 314264 0
Lifestyle
Comparator / control treatment
Usual Care Group: Participants allocated to usual care will receive ongoing care from their stem cell transplant team, but will not receive additional access to supervised exercise training. Usual care group participants will receive usual lifestyle advice provided to patients pre-transplant (individualised advice provided to each patient by their consultant haematologist and hospital allied health staff).
Control group
Active

Outcomes
Primary outcome [1] 319204 0
i. Peak oxygen uptake (VO2 peak, exercise test with ramp protocol),

Timepoint [1] 319204 0
-At baseline (prior to allogenic stem cell transplant)
-12 weeks post transplant
Primary outcome [2] 319833 0
ii. Peak cardiac output (exercise cardiac magnetic resonance imaging)
Timepoint [2] 319833 0
-At baseline (prior to allogeneic stem cell transplant)
-On completion of physical activity program approximately 16 weeks post stem cell transplant
Secondary outcome [1] 370249 0
i. Quality of life -Functional Assessment of Cancer Therapy with Bone Marrow Transplant; FACT-BMT Questionnaire (Validated Questionnaire)
Timepoint [1] 370249 0
-Baseline
-Post inpatient (approximately 4 weeks post stem cell transplant)
-On completion of physical activity program approximately 16 weeks post stem cell transplant
Secondary outcome [2] 370251 0
ii. Fatigue Functional Assessment of Chronic Illness Therapy (FACIT-fatigue) Questionnaire (Validated Questionnaire)
Timepoint [2] 370251 0
-Baseline
-Post inpatient (approximately 4 weeks post stem cell transplant)
-On completion of physical activity program approximately 16 weeks post stem cell transplant
Secondary outcome [3] 370252 0
iii. Functional independence (defined as VO2 peak of >18mL/kg/min) (CPET testing (bike))
Timepoint [3] 370252 0
-Baseline
-On completion of physical activity program approximately 16 weeks post stem cell transplant

Eligibility
Key inclusion criteria
1) Greater than or equal to 18 years of age, male or female
2) Scheduled to receive a myeloablative or reduced-intensity conditioning allogeneic SCT
3) Can exercise at the time of enrolment (e.g. walk up a flight of stairs)
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Unable to perform exercise magnetic resonance imaging
2) Planned for an outpatient, non-myeloablative allogeneic SCT
3) Unable to speak/understand English


Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After baseline testing, participants will be randomised to either physical activity or usual care condition. The randomisation schedule will be created by the Baker Institute statistician and entered into the REDCap database via the Baker Institute's database manager, a study investigator will enter the participants details into the database to receive the individual's randomisation. The investigators are blinded to the randomisation order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the physical activity intervention or usual care groups using permuted blocked randomisation stratified by conditioning intensity (myeloablative or reduced intensity), and sex (male or female) with a 1:1 allocation. Information related to the allocation sequence and block sizes will be kept on a separate, password protected database accessible only to the independent researcher and principle investigator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary outcomes will be be analysed via ANCOVA, comparing post-intervention data between groups with the corresponding baseline value as a covariate. A probability level of 0.025 will be adopted to account for dual endpoint testing. Our study has been adequately powered (80%) to detect a between group-difference in VO2 peak and peak cardiac output of 10% and 9% respectively. To detect this difference 20 completions per group are required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13379 0
The Alfred - Prahran
Recruitment postcode(s) [1] 25982 0
3004 - Prahran

Funding & Sponsors
Funding source category [1] 302010 0
Charities/Societies/Foundations
Name [1] 302010 0
World Cancer Research Fund International
Address [1] 302010 0
Avenue Louise 81, 1050 Brussels, Belgium
Numero d'entreprise 0471852243
Country [1] 302010 0
Belgium
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] 301882 0
None
Name [1] 301882 0
Address [1] 301882 0
Country [1] 301882 0
Other collaborator category [1] 280568 0
Hospital
Name [1] 280568 0
The Alfred Hospital
Address [1] 280568 0
55 Commercial Road, Melbourne VIC 3004
Country [1] 280568 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302686 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 302686 0
Level 5/553 St Kilda Road,
Melbourne VIC 3004
Ethics committee country [1] 302686 0
Australia
Date submitted for ethics approval [1] 302686 0
06/03/2019
Approval date [1] 302686 0
11/04/2019
Ethics approval number [1] 302686 0
134/19

Summary
Brief summary
The aim of this study is to test whether a structured physical activity program influences exercise capacity and heart, metabolic and muscle function in allogeneic stem cell transplant patients.

Metabolism or metabolic function refers to all chemical reactions that are involved in maintaining the living state of all cells within the body.

Who is it for?
You may be eligible to join this study if you are aged 18 years and above and if you have been scheduled to receive a allogeneic stem cell transplant.

Study details:
Participants in this study will be randomly allocated to one of two treatment groups as follows:
Treatment group 1: Participants in this group will receive the usual care when receiving an allogeneic stem cell transplant and will receive the usual guidelines in regards to physical activity provided by their treating haematologists.
Treatment group 2: Participants in this group will undertake a 16-week physical activity program that involves a sedentary reduction program and a structured exercise program. This 16 week program will begin from the time of admission to hospital for the stem cell transplant (approximately 4 weeks as an inpatient, 12 weeks as an outpatient). Participants in this group will also wear a wearable activity device for the duration of the physical activity program.

It is hoped this research will contribute to research surrounding the exercise capacity, heart, metabolic and muscle function of patients receiving allogeneic stem cell transplants. It is also hoped that this study will determine if a physical activity intervention can improve quality of life, reduce symptoms of fatigue and improve functional independence in these patients, compared with the usual treatment programs that currently exist.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 91054 0
A/Prof Andre La Gerche
Address 91054 0
Level 4, Alfred Centre -Sports Cardiology Laboratory,
Baker Heart and Diabetes Institute,
99 Commercial Road, Melbourne VIC 3004
Country 91054 0
Australia
Phone 91054 0
+61 3 8532 1800
Fax 91054 0
+61 3 8532 1899
Email 91054 0
andre.lagerche@baker.edu.au
Contact person for public queries
Name 91055 0
Ms Carla Edgley
Address 91055 0
Baker Heart and Diabetes Institute,
75 Commercial Road, Melbourne VIC 3004
Country 91055 0
Australia
Phone 91055 0
+61 3 8532 1182
Fax 91055 0
+61 3 8532 1899
Email 91055 0
carla.edgley@baker.edu.au
Contact person for scientific queries
Name 91056 0
Dr Erin Howden
Address 91056 0
Level 4, Alfred Centre - Sports Cardiology Laboratory,
Baker Heart and Diabetes Institute,
99 Commercial Road, Melbourne VIC 3004
Country 91056 0
Australia
Phone 91056 0
+61 3 8532 1861
Fax 91056 0
+61 3 8532 1899
Email 91056 0
erin.howden@baker.edu.au

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 (re-identifiable) data will only be shared. 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 (re-identifiable) 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 Andre La Gerche
Email: andre.lagerche@baker.edu.au

What supporting documents are/will be available?
Study protocol
Statistical analysis plan
Informed consent form
Ethical approval
Summary results
No Results