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Trial registered on ANZCTR


Registration number
ACTRN12619000387123
Ethics application status
Approved
Date submitted
28/02/2019
Date registered
12/03/2019
Date last updated
17/09/2021
Date data sharing statement initially provided
12/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Exercise on Health Outcomes in Multiple Myeloma
Scientific title
The MyeEx Study: The Effect of an Individualised Exercise Intervention on Functional, Biological and Quality of Life Outcomes in Patients with Multiple Myeloma
Secondary ID [1] 297021 0
None
Universal Trial Number (UTN)
Trial acronym
MyeEx
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple myeloma 311053 0
Condition category
Condition code
Cancer 309689 309689 0 0
Myeloma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a structured and individualised 12-week exercise program (Stage 1)
Stage 1: Participants will aim to complete three hour-long exercise sessions per week. For twelve weeks, an accredited exercise physiologist (AEP) will directly supervise two hour-long gym-based sessions per week, either individually or in groups of up to 5 participants. Participants will also be provided with exercise prescription for one session per week as a self-managed home session. The AEP will individually tailor exercises for all participants, being cognisant of neutropenic risks, lytic lesions and spinal instability. A multi-modal program of high-intensity aerobic exercise (using cycle ergometers), resistance training (using free and machine weights and therabands) and impact loading (using steps and hurdles) will be prescribed during the intervention, individualised to the participants’ cardiorespiratory fitness and bone lesions and closely monitored by the AEP. Heart rate monitors and the rating of perceived exertion (RPE) will be used to monitor intensity. Exercise maintenance strategies will be utilised to enhance adherence to the home-based exercise program.

Stage 1: Twelve weeks gym-based program = 2 x supervised sessions and 1 home-based session per week. All supervised classes will be delivered by an Accredited Exercise Physiologist.
Stage 2: Twelve weeks home-based program (3 sessions/week) with weekly telephone support. These weekly 5-10 minute calls will be provided by a qualified health professional to discuss adherence and other issues (e.g. symptoms). There is the option to replace one home-based session with a group class conducted by the Accredited Exercise Physiologist.
Stage 3: Maintain home-based program (at least 3 sessions/week) for a further 6 months. Follow-up testing at 12 months from baseline measures.

Adherence to exercise program will be monitored at supervised sessions (initial 12 weeks), home exercise log with weekly telephone follow-up (for subsequent 12 weeks), and 7-day accelerometer data at each testing period (baseline, 12 weeks, 24 weeks, 12 months).

Compliance will be assessed as 70% adherence to recommended exercise program (intensity, type, time, and frequency)

Dietary control will also be monitored on 3 days prior to each testing period by a self-administered food diary.
Intervention code [1] 313344 0
Treatment: Other
Intervention code [2] 313345 0
Lifestyle
Intervention code [3] 313346 0
Behaviour
Comparator / control treatment
Wait-list control group with multiple myeloma who will undertake usual care for 12 weeks until being offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 318674 0
Change in health-related quality of life scores assessed via EORTC-QLQ-C30 (version 3) combined with the MY20 module.
Timepoint [1] 318674 0
12 weeks
Secondary outcome [1] 366286 0
Changes in health-related quality of life scores, as assessed via the Functional Assessment of Cancer Therapy - Multiple Myeloma (FACT-MM) (Version 4) questionnaire.
Timepoint [1] 366286 0
Baseline, 12 weeks, 24 weeks and 12 months for those initially randomised to the exercise intervention (EX), while those initially randomised to the Waitlist Control (WC) group will have an additional testing period (i.e. baseline, 12 weeks, 24 weeks, 36 weeks and 15 months).
Secondary outcome [2] 367454 0
Changes in health-related quality of life scores, as assessed via the Myeloma Patients Outcome Scale (MyPOS) questionnaire.
Timepoint [2] 367454 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [3] 367455 0
Change in health-related quality of life scores assessed via EORTC-QLQ-C30 (version 3) combined with the MY20 module.
Timepoint [3] 367455 0
Repeated measures at 24 weeks and 12 months for those initially randomised to the EX intervention, while those initially randomised to the WC group will have an additional testing period (24 weeks, 36 weeks and 15 months).
Secondary outcome [4] 367456 0
Changes in cardiorespiratory fitness (VO2peak), as assessed via a Cardiopulmonary Exercise Test (CPET) using a cycle ergometer and metabolic system.
Timepoint [4] 367456 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [5] 367457 0
Cancer-related fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire.
Timepoint [5] 367457 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [6] 367459 0
Nature, severity and impact of pain assessed using the Brief Pain Inventory (BPI) questionnaire.
Timepoint [6] 367459 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [7] 367460 0
Nature, severity and impact of pain will be assessed using the Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) questionnaire.
Timepoint [7] 367460 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [8] 367461 0
Nature, severity and impact of pain will be assessed using the Oswestry Low Back Pain Disability questionnaire.
Timepoint [8] 367461 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [9] 367462 0
Body composition will be assessed using Dual-energy x-ray absorptiometry (DXA, Hologic Discovery). A full body scan will be used to assess total body lean tissue mass, total body fat mass, total body fat percentage, total body bone mineral density, and bone mineral densities of the lumbar spine and femoral neck.
Timepoint [9] 367462 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [10] 367463 0
Changes in bone architecture at appendicular, non-lesion control sites of the femur, distal radius and distal tibia will be assessed to quantify bone material, structure and strength using peripheral Quantitative Computed Tomography (pQCT).
Timepoint [10] 367463 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [11] 367464 0
Changes in muscle mass will be assessed using pQCT. Cross-sectional scans will be performed of the femur, tibia and distal radius.
Timepoint [11] 367464 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [12] 367465 0
Lower limb power will be assessed by the 30 second Sit-to-Stand test (30STS).
Timepoint [12] 367465 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [13] 367466 0
Changes in estimated overall muscle strength, as assessed via hand grip strength of both the dominant and non-dominant hands using a hand-held dynamometer.
Timepoint [13] 367466 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [14] 367468 0
Changes in cytokine markers, including adipokines (adiponectin, leptin, resistin), will be assessed in serological samples. Other cytokines to be assessed have not been determined as it will take an exploratory approach.
Timepoint [14] 367468 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [15] 367471 0
Markers of disease progression (M-protein, serum free light chains, beta-2 microglobulin, lactate dehydrogenase (LDH), C-reactive protein (CRP), albumin) will be assessed in serological samples.
Timepoint [15] 367471 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [16] 367472 0
Bone metabolic activity will be measured in serological samples. Specifically, bone formation markers, procollagen type 1 N propeptide (P1NP) and alkaline phosphatase (ALP) ; bone resorption marker, C-terminal telopeptide of type 1 collagen (CTx).
Timepoint [16] 367472 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [17] 367473 0
Changes in the global metabolite, proteome and lipidome as assessed by liquid chromatography-coupled tandem mass spectroscopy analysis.
Timepoint [17] 367473 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [18] 367474 0
Changes in habitual physical activity and sedentary behaviours, as assessed via accelerometery using an ActiGraph GT3X+ accelerometer.
Timepoint [18] 367474 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [19] 367478 0
Changes in habitual physical activity and sedentary behaviours, as assessed via self-recorded activity using the Godin Leisure-Time Exercise Questionnaire.
Timepoint [19] 367478 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [20] 367479 0
Changes in dynamic balance will be assessed using the Y Balance Test (YBT), which measures the participant’s strength, stability and balance in various directions.
Timepoint [20] 367479 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [21] 367589 0
Level of concern about falls will be assessed using the Falls Self-Efficacy (FES) questionnaire.
Timepoint [21] 367589 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [22] 367814 0
Enjoyment of exercise sessions will be assessed by the Physical Activity Enjoyment Scale (PACES).
Timepoint [22] 367814 0
Every four weeks during Stage 1.
Secondary outcome [23] 367815 0
Anthropometry, including body mass, stature and waist and hip circumference, will be assessed.
Timepoint [23] 367815 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [24] 367816 0
Safety will be measured by data collected on adverse events.
Participants will be advised that they should report any spontaneous adverse events that may occur during the study, and will be provided with contact details for reporting.
During Stage 1 and Stage 2 participants will be questioned weekly about adverse events at supervised sessions or by weekly telephone support. During Stage 3 participants will be questioned at the 12 month follow-up.
Participants will be encouraged to use the contact details for reporting adverse events at any time throughout the study period. The type, incidence, and severity of adverse events (Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Life-threatening; and Grade 5: Death) will be noted. Examples of adverse effects would be musculoskeletal injury, angina, hypotension, heightened skeletal pain.
Timepoint [24] 367816 0
Data will be collected on a continual basis. Data will be analysed at 12 weeks, 24 weeks and 12 months.
Secondary outcome [25] 367817 0
Exercise adherence will be assessed as 70% compliance to the prescribed type, frequency, intensity, and duration of exercise sessions/week.
A combination of physical attendance, self-reporting, and activity device data (accelerometer) will be used. The participant will be deemed compliant if they achieve 70% of the randomized exercise protocol targets each week.
During Stage 1, exercise adherence will be recorded on the exercise data sheets at supervised exercise sessions. At each exercise session, participants will be asked if they have completed any home-based sessions since their previous supervised sessions, and the nature of this session.
During Stage 2, exercise adherence will be self-reported by participants during their routine telephone support session. They will be asked how many sessions they have completed for the week, and the duration and intensity of those sessions. During the supervised sessions participants will be taught how to monitor their exercise intensity using heart rate and rating of perceived effort (RPE). They will be encouraged to keep an exercise log to track this data for their home-based sessions.
During Stage 3, exercise adherence will be self-reported by participants during their 12 month follow-up session. Accelerometer data, captured for 7 days at each testing period, will also be used to assess compliance to the exercise protocol.
Timepoint [25] 367817 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group.
Secondary outcome [26] 367818 0
Cost-benefits in both groups during the intervention period, as assessed by appraisal of labour (e.g. to deliver the intervention) and non-labour (e.g. gymnasium use, pain medication) costs. Resource use will be costed at market rates (e.g. industrial award rates for labour costs), for use in cost-effectiveness analyses.
Timepoint [26] 367818 0
At the conclusion of the study
Secondary outcome [27] 381246 0
Changes in lower limb muscle strength will be assessed by the isometric mid-thigh pull
Timepoint [27] 381246 0
Baseline, 12 weeks, 24 weeks, 12 months for EX group; baseline, 12 weeks, 24 weeks, 36 weeks and 15 months for WC group
Secondary outcome [28] 381247 0
The experiences of participants during the program and the perceived benefits and barriers of the intervention will be assessed using a semi-structured qualitative interview.
Timepoint [28] 381247 0
24 weeks

Eligibility
Key inclusion criteria
- Diagnosis of multiple myeloma
- Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study
- Cognitively capable of consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Abnormal resting electrocardiogram
- Unstable angina
- Cognitive impairment that impedes the ability to complete questionnaires
- Any intellectual or physical disability which would make exercise intervention participation unsafe for the individual

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 randomisation process for this trial is performed by a person external to the study (an academic from The University of Queensland, St Lucia). Study investigators and exercise physiologists conducting testing procedures will be blinded to group allocation. Only exercise physiologists who are not in the research team will be permitted to deliver the exercise intervention to participants in order to maintain integrity of the blinding process.
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 wait-list control group by the external person. Randomisation will be performed electronically online, stratified for disease stage (newly diagnosed/post transplant/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
Other
Other design features
Participants randomised to the wait-list control group will be encouraged to maintain current activity levels for 12 weeks before commencing the exercise intervention.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
44 participants are required for >80% power to detect a minimally important mean difference of 6.7 points between groups at 12 weeks post exercise on the primary outcome (EORTC QLQ-C30 MY20). Recruitment of 65 participants allows up to 25% attrition, SD=13.4 and alpha=0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/03/2019
Actual
29/04/2019
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
65
Accrual to date
37
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 13009 0
Greenslopes Private Hospital - Greenslopes
Recruitment hospital [2] 13010 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [3] 16128 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 20544 0
North Lakes Health Precinct - North Lakes
Recruitment postcode(s) [1] 25493 0
4120 - Greenslopes
Recruitment postcode(s) [2] 25494 0
4102 - Woolloongabba
Recruitment postcode(s) [3] 29656 0
4029 - Herston
Recruitment postcode(s) [4] 35327 0
4509 - North Lakes

Funding & Sponsors
Funding source category [1] 301589 0
University
Name [1] 301589 0
The University of Queensland
Country [1] 301589 0
Australia
Funding source category [2] 305261 0
Charities/Societies/Foundations
Name [2] 305261 0
Brisbane Diamantina Health Partners
Country [2] 305261 0
Australia
Primary sponsor type
Individual
Name
Dr Tina Skinner
Address
Senior Lecturer in Exercise Physiology
School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 301287 0
Individual
Name [1] 301287 0
Associate Professor Michelle Hill
Address [1] 301287 0
Group Leader
Precision and Systems Biomedicine, QIMR Berghofer Medical Research Institute, Herston Road, Herston QLD 4006
Country [1] 301287 0
Australia
Secondary sponsor category [2] 301548 0
Individual
Name [2] 301548 0
Jennifer Nicol
Address [2] 301548 0
School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia QLD 4072
Country [2] 301548 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302319 0
Greenslopes Research and Ethics Committee
Ethics committee address [1] 302319 0
Ethics committee country [1] 302319 0
Australia
Date submitted for ethics approval [1] 302319 0
28/11/2018
Approval date [1] 302319 0
13/12/2018
Ethics approval number [1] 302319 0
18/58
Ethics committee name [2] 302499 0
The University of Queensland Human Research Ethics Committees
Ethics committee address [2] 302499 0
Ethics committee country [2] 302499 0
Australia
Date submitted for ethics approval [2] 302499 0
20/12/2018
Approval date [2] 302499 0
09/01/2019
Ethics approval number [2] 302499 0
2018002644/18/58
Ethics committee name [3] 305604 0
Metro South Human Research Ethics Committee
Ethics committee address [3] 305604 0
Ethics committee country [3] 305604 0
Australia
Date submitted for ethics approval [3] 305604 0
17/01/2019
Approval date [3] 305604 0
27/03/2019
Ethics approval number [3] 305604 0
HREC/2019/QMS/47400

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

Contacts
Principal investigator
Name 89806 0
Mrs Jennifer Nicol
Address 89806 0
School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072
Country 89806 0
Australia
Phone 89806 0
+61 409769373
Fax 89806 0
Email 89806 0
[email protected]
Contact person for public queries
Name 89807 0
Jennifer Nicol
Address 89807 0
School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072
Country 89807 0
Australia
Phone 89807 0
+61 409769373
Fax 89807 0
Email 89807 0
[email protected]
Contact person for scientific queries
Name 89808 0
Jennifer Nicol
Address 89808 0
School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072
Country 89808 0
Australia
Phone 89808 0
+61 409769373
Fax 89808 0
Email 89808 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
SourceTitleYear of PublicationDOI
EmbaseAn Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial.2022https://dx.doi.org/10.3390/curroncol29020077
N.B. These documents automatically identified may not have been verified by the study sponsor.