Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000127505
Ethics application status
Approved
Date submitted
5/01/2024
Date registered
12/02/2024
Date last updated
12/02/2024
Date data sharing statement initially provided
12/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Re-building bone with exercise in multiple myeloma
Scientific title
Bone-targeted supervised exercise for people with multiple myeloma: a randomised controlled trial assessing the effect on bone mineral density (the MyeEx-Impact trial)
Secondary ID [1] 310697 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MyeEx-Impact
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 331607 0
Condition category
Condition code
Cancer 328349 328349 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A structured, supervised, and individualised 9-month exercise program, three times per week for one hour in duration.
Participants will be supervised by an accredited exercise physiologist (AEP) for two sessions per week, either individually or in groups of up to 5 participants, in hospital, university or private gyms. In addition, one self-managed unsupervised exercise session per week will be prescribed. The AEP will individually tailor exercises for all participants, with consideration of neutropenic risks, lytic lesions, and spinal instability. A multi-modal program of bone-targeted high-intensity resistance training (using free and machine weights and therabands), impact loading (using steps and hurdles), and aerobic exercise training (using stationary cycles and treadmills) will be prescribed.
Attendance will be monitored using a session log and by the participant using self-reporting exercise diaries. Exercise adherence at the in-person sessions will be monitored by the AEP using heart rate monitors, and session checklists for progression, intensity (Borg 6-20 and OMNI-RES 0-10 RPE scales), numbers of sets or impacts, and repetitions. Aerobic training will commence at low-intensity (9–10 Borg RPE), with 2 bouts at high-intensity (16-19 Borg RPE), interspersed by recovery (12-15 Borg RPE). Resistance exercises will commence at a low intensity, gradually progressing in intensity to high (6-9 OMNI-RES) throughout the intervention, guided by participant responses.
Intervention code [1] 327099 0
Treatment: Other
Intervention code [2] 327100 0
Lifestyle
Intervention code [3] 327101 0
Behaviour
Comparator / control treatment
Control group with multiple myeloma will continue with their usual medical care (defined as the current standard of care). This may include the provision of low-intensity physiotherapy services which does not include high-intensity resistance or impact training, for 9 months; and will be provided with print material recommendations by Myeloma Australia.
Control group
Active

Outcomes
Primary outcome [1] 336253 0
Change in areal bone mineral density (aBMD) of total hip
Timepoint [1] 336253 0
Baseline, 9-months post-randomisation
Primary outcome [2] 336254 0
Change in areal bone mineral density (aBMD) of lumbar spine
Timepoint [2] 336254 0
Baseline, 9-months post-randomisation
Secondary outcome [1] 427534 0
Areal bone mineral density (aBMD) of whole body
Timepoint [1] 427534 0
Baseline, 9-months post-randomisation
Secondary outcome [2] 427535 0
Hip bone geometry and volumetric parameters: femoral neck trabecular and cortical volume, trabecular and cortical bone mineral content (BMC), trabecular and cortical volumetric BMD, and femoral neck cortical thickness.
These are multiple separate outcomes and it is not a composite outcome.
Timepoint [2] 427535 0
Baseline, 9-months post-randomisation
Secondary outcome [3] 427536 0
Bone geometry and volumetric parameters at appendicular, non-lesion control sites of the femur and distal tibia: trabecular and cortical volume, trabecular and cortical BMC, trabecular and cortical volumetric BMD.
These are multiple separate outcomes and it is not a composite outcome.
Timepoint [3] 427536 0
Baseline, 9-months post-randomisation
Secondary outcome [4] 427537 0
Bone pain
Timepoint [4] 427537 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [5] 427538 0
Opiate requirements
Timepoint [5] 427538 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [6] 427539 0
Health-related quality of life
Timepoint [6] 427539 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [7] 427540 0
Cancer-related fatigue
Timepoint [7] 427540 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [8] 427541 0
Health-related quality of life
Timepoint [8] 427541 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [9] 427542 0
Health-related quality of life
Timepoint [9] 427542 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [10] 427543 0
Breathlessness
Timepoint [10] 427543 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [11] 427544 0
Depression
Timepoint [11] 427544 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [12] 427545 0
Anxiety
Timepoint [12] 427545 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [13] 427547 0
Severity of insomnia
Timepoint [13] 427547 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [14] 427548 0
Peripheral neuropathy
Timepoint [14] 427548 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [15] 427549 0
Estimated overall muscle strength via hand grip strength of both dominant and non-dominant hands
Timepoint [15] 427549 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [16] 427550 0
Lower limb power
Timepoint [16] 427550 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [17] 427551 0
Lower limb muscle strength
Timepoint [17] 427551 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [18] 427552 0
Dynamic balance, with measures of participants' strength, stability, and balance in various directions
Timepoint [18] 427552 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [19] 427553 0
Dynamic balance, with a measure of participants' ability to maintain balance during a functional task
Timepoint [19] 427553 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [20] 427554 0
Functional mobility
Timepoint [20] 427554 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [21] 427555 0
Exercise capacity
Timepoint [21] 427555 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [22] 427556 0
Self-reported habitual physical activity
Timepoint [22] 427556 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [23] 427557 0
Habitual physical activity
Timepoint [23] 427557 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [24] 427558 0
Bone-specific physical activity
Timepoint [24] 427558 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [25] 427560 0
Anthropometry, including body mass, stature, and waist and hip circumference
Timepoint [25] 427560 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [26] 427561 0
Body composition. A full body scan will be used to assess total body lean tissue mass, total body fat mass, and total body fat percentage.
Timepoint [26] 427561 0
Baseline, 9-months post-randomisation
Secondary outcome [27] 427562 0
Muscle mass, with cross-sectional scans of the femur and tibia
Timepoint [27] 427562 0
Baseline, 9-months post-randomisation
Secondary outcome [28] 427563 0
Tumour progression and bone disease
Timepoint [28] 427563 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [29] 427564 0
Bone formation markers, procollagen type 1 N propeptide (P1NP) and alkaline phosphatase (ALP) in serological samples (plasma)
Timepoint [29] 427564 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [30] 427565 0
Bone resorption marker, C-terminal telopeptide of type 1 collagen (CTx) assessed in serological samples (plasma)
Timepoint [30] 427565 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [31] 427566 0
Cytokine markers, including C-reactive protein, will be assessed in serological samples. Other cytokines to be assessed have not been determined as an exploratory approach will be adopted.
Timepoint [31] 427566 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [32] 427567 0
Beta-2-microglobumin in serological samples (plasma)
Timepoint [32] 427567 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [33] 427568 0
Gut microbiome
Timepoint [33] 427568 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [34] 427569 0
Safety
Timepoint [34] 427569 0
Collected on a continual basis for up to 9-months post-randomisation
Secondary outcome [35] 427570 0
Exercise adherence. Assessed as 75% compliance to the prescribed type, frequency, intensity, and duration of exercise sessions/week.
Timepoint [35] 427570 0
Collected on a continual basis for up to 9-months post-randomisation
Secondary outcome [36] 427572 0
Enjoyment of exercise sessions
Timepoint [36] 427572 0
Every 4 weeks for up to 9-months post-randomisation for the intervention group only
Secondary outcome [37] 430365 0
Health care utilisation costs
Timepoint [37] 430365 0
Baseline, 3-months and 9-months post-randomisation
Secondary outcome [38] 430428 0
Experiences of participants assigned to intervention group during the program and the perceived benefits and barriers of the interventions
Timepoint [38] 430428 0
9-months post-randomisation for the intervention group only
Secondary outcome [39] 431021 0
Sedentary behaviours
Timepoint [39] 431021 0
Baseline, 3-months and 9-months post-randomisation

Eligibility
Key inclusion criteria
i. Diagnosis of multiple myeloma;
ii. Aged greater than or equal to 18 years;
iii. Performance status 0–2, as per Eastern Cooperative Oncology Group scoring system (ECOG)
iv. Currently taking bisphosphonates.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Undertaking similar exercise to the intervention;
ii. Deemed unsafe to participate in exercise by their treating doctor;
iii. Cognitive impairment that impedes the ability to complete questionnaires.

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)
Allocation is concealed at baseline. The person who determines if a subject is eligible for inclusion in the trial is unaware, when this decision is made, to which group the subject will be allocated. The randomisation process for this trial is performed by a person external to the study (an academic from The University of Queensland, St Lucia).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individuals who provide written informed consent to participate in the trial are randomised at a 1:1 ratio to either the intervention or control group by the external person. Randomisation will be performed electronically online, stratified for disease stage (newly diagnosed transplant-eligible/newly diagnosed transplant-noneligible/non-active/relapsed). Participants who drop out prior to completing baseline testing will not be randomised.
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
39 participants per group (intervention and control) will be required to detect a 2.3% between-group difference in total hip (Cohen’s d=1.36) and 4.1% between-group difference in lumbar spine (Cohen’s d=0.67) bone mineral density, with a significance level of 0.05 and 80% power. Attrition has been estimated at 30% so a total of 78 participants will be recruited.
Intention-to-treat analysis
Qualitative assessment and thematic analysis
Cost-effectiveness analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/02/2024
Actual
Date of last participant enrolment
Anticipated
23/02/2026
Actual
Date of last data collection
Anticipated
23/11/2026
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 25697 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 25698 0
The Chris O’Brien Lifehouse - Camperdown
Recruitment hospital [3] 25699 0
Griffith University – Nathan Campus - Nathan
Recruitment hospital [4] 25700 0
University of Queensland - St Lucia
Recruitment postcode(s) [1] 41521 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 41522 0
2050 - Camperdown
Recruitment postcode(s) [3] 41523 0
4111 - Nathan
Recruitment postcode(s) [4] 41524 0
4072 - St Lucia

Funding & Sponsors
Funding source category [1] 314913 0
Charities/Societies/Foundations
Name [1] 314913 0
World Cancer Research Fund International
Country [1] 314913 0
United Kingdom
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway Ultimo, NSW 2007
Country
Australia
Secondary sponsor category [1] 316920 0
None
Name [1] 316920 0
Address [1] 316920 0
Country [1] 316920 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313906 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 313906 0
Ethics committee country [1] 313906 0
Australia
Date submitted for ethics approval [1] 313906 0
17/11/2022
Approval date [1] 313906 0
31/01/2023
Ethics approval number [1] 313906 0
HREC/2022/QMS/91617

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

Contacts
Principal investigator
Name 129742 0
A/Prof Tina Skinner
Address 129742 0
15 Broadway, University of Technology Sydney, Ultimo, NSW 2007
Country 129742 0
Australia
Phone 129742 0
+61 414 969 732
Fax 129742 0
Email 129742 0
[email protected]
Contact person for public queries
Name 129743 0
Jennifer Nicol
Address 129743 0
Connell Bldg, Cnr Blair Drive and Union Road, The University of Queensland, St Lucia QLD, 4072
Country 129743 0
Australia
Phone 129743 0
+61 409769373
Fax 129743 0
Email 129743 0
[email protected]
Contact person for scientific queries
Name 129744 0
Tina Skinner
Address 129744 0
15 Broadway, University of Technology Sydney, Ultimo, NSW 2007
Country 129744 0
Australia
Phone 129744 0
+61 414 969 732
Fax 129744 0
Email 129744 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.