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Trial registered on ANZCTR


Registration number
ACTRN12618000888268
Ethics application status
Approved
Date submitted
18/05/2018
Date registered
28/05/2018
Date last updated
6/06/2019
Date data sharing statement initially provided
8/11/2018
Date results information initially provided
6/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Preventing functional decline in allogeneic bone marrow transplant: the BOOST study
Scientific title
Feasibility of an early commencing hospital-based exercise program to prevent functional decline in people with haematological malignancy treated with allogeneic bone marrow transplant: the BOOST study
Secondary ID [1] 294900 0
Nil known
Universal Trial Number (UTN)
U1111-1214-2383
Trial acronym
BOOST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haematological cancer 307862 0
Condition category
Condition code
Cancer 306906 306906 0 0
Leukaemia - Acute leukaemia
Blood 307029 307029 0 0
Haematological diseases
Cancer 307030 307030 0 0
Leukaemia - Chronic leukaemia
Cancer 307031 307031 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 307032 307032 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants will receive a protocolised exercise and education program for the duration of their inpatient admission for their allogeneic bone marrow transplant (alloBMT). The program will include both aerobic and resistance training, to maximise health benefits as per international exercise guidelines, provided by a physiotherapist in a supervised group setting. Each patient will receive individualised exercise based on their self-reported well-being and their objectively measured functional exercise capacity. A “traffic light” system will be used where patients can be grouped into three categories based on their self-rated well-being at each session (red, yellow and green) in order to tailor the exercise intervention (as described by Wiskemann et al, Blood, March 2011: 117; 9). The target intensity will be 3-5 on the Modified Borg scale of breathlessness for aerobic exercise, and 12-14 on the Rating of Perceived Exertion (RPE) scale for resistance exercise. The sessions will operate for up to 1-hour up to 5-days per week in the recreation room on the Bone Marrow Transplant hospital ward. Equipment to be used already exists on the ward and includes an exercise bike, treadmill, hand weights, steps and arm ergometer. Adherence to the exercise program will be recorded by the physiotherapist in the participant's exercise log; participant's will have their own exercise diary to encourage compliance with the program during their hospital stay and upon discharge from hospital. Education will be integrated into the program through a weekly session facilitated by a different member of the multi-disciplinary team for approximately 20-minutes after the exercise session. Topics will include nutrition, staying motivated, return to work.
Intervention code [1] 301212 0
Rehabilitation
Intervention code [2] 301317 0
Prevention
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305895 0
The primary outcome of this study is to determine the feasibility. Participant adherence to exercise sessions and numbers/reasons for drop-outs will be recorded. Adverse events will be recorded and monitored during exercise testing and training sessions.
Timepoint [1] 305895 0
Feasibility will be measured for the duration of participant involvement in the study, from baseline pre-transplant until 60-days post-transplant.
Secondary outcome [1] 346942 0
Functional exercise capacity will be measured using an incremental shuttle walk test (ISWT). Participants will be asked to walk along a 10m flat course, gradually increasing their walking speed until they are no longer able to keep up with the sound of a ‘beep’ that gets progressively faster.
Timepoint [1] 346942 0
The ISWT will be measured at four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant.
Secondary outcome [2] 346945 0
Short Physical Performance Battery (SPPB) is a short group of tests which measures standing balance, sit to stand and walking speed (over 4 metres) combined to provide a total score from zero to twelve. This composite test is used to monitor function and physical performance.
Timepoint [2] 346945 0
The SPPB will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant, as well as weekly during the participant's inpatient stay to assess progress of their exercise program.
Secondary outcome [3] 346947 0
Muscle strength will be measured bilaterally for quadriceps using a Powertrack II Commander 1500 hand-held dynamometer and handgrip using a Jamar handgrip dynamometer.
Timepoint [3] 346947 0
Muscle strength will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant, as well as weekly during the participant's inpatient stay to assess progress of their exercise program.
Secondary outcome [4] 346950 0
Physical activity levels objectively measured (steps recorded using Sensewear devices); and self-reported questionnaire, the International Physical Activity Questionnaire (IPAQ).
Timepoint [4] 346950 0
The Sensewear will be worn for seven consecutive days during the participant's inpatient stay; the IPAQ will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant.
Secondary outcome [5] 346951 0
Self-efficacy for physical activity will be measured with the Physical Activity Assessment Inventory (PAAI), a tool specifically developed to measure self-efficacy for both structured and unstructured energy expenditure.
Timepoint [5] 346951 0
The PAAI will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant.
Secondary outcome [6] 346953 0
Health related quality of life (HRQoL) will be measured with the Functional Assessment of Cancer Therapy (FACT-BMT) questionnaire. The FACT-BMT is a 50-item questionnaire specifically tailored for the assessment of HRQoL in people treated with a bone marrow transplant. The questionnaire involves five domains: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB) and additional concerns.
Timepoint [6] 346953 0
The FACT-BMT will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant.
Secondary outcome [7] 346954 0
"InBody 770" Body Composition Analyser will be used to estimate fat, muscle and water composition by using bioelectric impedence analysis.
Timepoint [7] 346954 0
Body composition will be measured at all four outcome measurement time-points: (1) pre-transplant, (2) admission to hospital, (3) discharge from hospital, (4) 60-days post-transplant, as well as weekly during the participant's inpatient stay.
Secondary outcome [8] 346956 0
Healthcare resource usage over the first 60 days post-alloBMT (intensive care admissions, hospital readmissions, length of stay) and participant medical and social demographic characteristics (age, sex, occupation, diagnosis, complications etc) using data linkage to medical records and study-specific demographic questionnaires will be recorded.
Timepoint [8] 346956 0
First 60-days of BMT.

Eligibility
Key inclusion criteria
The safety of each participant to participate in exercise will be assessed daily on an individual basis. In order to participate in group exercise on any given day, participant's must fulfil the following safety criteria:
- Vital observations within normal limits as per hospital protocol
- Platelet count greater than or equal to 15 x 10^9/L (resistance exercise can commence when platelet count is 20 or greater)
- Haemoglobin count greater than 80 g/L
- If a participant is in contact isolation, they may participate in group exercise if they wear gloves; if a participant is in respiratory isolation, they may not participate in group exercise.
- Note, as the exercise group takes place on a pressurised ward there is no contraindication to group exercise with low neutrophil count.
- Note, all participants are advised to practice hand hygiene and clean equipment before/after use.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe active psychiatric or cognitive disorder or unable to provide consent; presence of a musculoskeletal co-morbidity preventing exercise.

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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] 10898 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 22664 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 299482 0
Hospital
Name [1] 299482 0
Royal Melbourne Hospital
Address [1] 299482 0
Grattan Street
Parkville 3050
Victoria
Country [1] 299482 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Grattan Street
Parkville 3050
Victoria
Country
Australia
Secondary sponsor category [1] 298788 0
None
Name [1] 298788 0
Address [1] 298788 0
Country [1] 298788 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300389 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300389 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 300389 0
Australia
Date submitted for ethics approval [1] 300389 0
30/01/2018
Approval date [1] 300389 0
04/04/2018
Ethics approval number [1] 300389 0
HREC/18/MH/48

Summary
Brief summary
The purpose of this study is determine the feasibility of an inpatient and subsequent home based exercise and education program for patients undergoing allogeneic bone marrow transplant for haematological cancer at the Royal Melbourne Hospital.

Who is it for?
You may be eligible for this study if you are an adult aged 18 years or above, planned to undergo an allogeneic bone marrow transplant for haematological cancer at the Royal Melbourne Hospital.

Study details
All participants will receive a protocolised exercise and education program for the duration of their inpatient admission for their allogeneic bone marrow transplant (alloBMT). The program will include aerobic and resistance training at an individualised level, provided by a physiotherapist in a supervised group setting. The sessions will operate for up to 1-hour up to 5-days per week.
Measurement of physical function, physical activity levels, health-related quality of life and body composition will be completed at four time-points: (1) recruitment to the study (approximately 1 month pre-alloBMT); (2) hospital admission; (3) hospital discharge (usually one month after admission); and, (4) 60 days post-alloBMT. We will also obtain consumer feedback through questionnaires and interviews, and look at health care resource usage. This study will provide important information to generate evidence to target our resources in an attempt to minimise physical burden associated with haematological (blood) cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83498 0
Ms Shaza Abo
Address 83498 0
The Royal Melbourne Hospital - City Campus
Level 4 North - Allied Health
Grattan Street, Parkville Victoria 3052
Country 83498 0
Australia
Phone 83498 0
+613 9342 7440
Fax 83498 0
Email 83498 0
shazasandra.abo@mh.org.au
Contact person for public queries
Name 83499 0
Ms Shaza Abo
Address 83499 0
The Royal Melbourne Hospital - City Campus
Level 4 North - Allied Health
Grattan Street, Parkville Victoria 3052
Country 83499 0
Australia
Phone 83499 0
+613 9342 7440
Fax 83499 0
Email 83499 0
shazasandra.abo@mh.org.au
Contact person for scientific queries
Name 83500 0
Dr Catherine Granger
Address 83500 0
The University of Melbourne
Level 7, Alan Gilbert Building, 161 Barry Street, Parkville 3010, VIC
Country 83500 0
Australia
Phone 83500 0
+613 8344 8126
Fax 83500 0
Email 83500 0
Catherine.Granger@unimelb.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No as we did not explicitly ask participants to consent to the sharing and re-use of their data.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
N/A as yet.