ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

MyeEx

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Multiple myeloma

Condition category

Condition code

Cancer

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]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Change in health-related quality of life scores assessed via EORTC-QLQ-C30 (version 3) combined with the MY20 module.

Timepoint [1]

12 weeks

Secondary outcome [1]

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]

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]

Changes in health-related quality of life scores, as assessed via the Myeloma Patients Outcome Scale (MyPOS) questionnaire.

Timepoint [2]

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]

Change in health-related quality of life scores assessed via EORTC-QLQ-C30 (version 3) combined with the MY20 module.

Timepoint [3]

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]

Changes in cardiorespiratory fitness (VO2peak), as assessed via a Cardiopulmonary Exercise Test (CPET) using a cycle ergometer and metabolic system.

Timepoint [4]

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]

Cancer-related fatigue measured using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) questionnaire.

Timepoint [5]

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]

Nature, severity and impact of pain assessed using the Brief Pain Inventory (BPI) questionnaire.

Timepoint [6]

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]

Nature, severity and impact of pain will be assessed using the Functional Assessment of Cancer Therapy - Bone Pain (FACT-BP) questionnaire.

Timepoint [7]

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]

Nature, severity and impact of pain will be assessed using the Oswestry Low Back Pain Disability questionnaire.

Timepoint [8]

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]

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]

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]

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]

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]

Changes in muscle mass will be assessed using pQCT. Cross-sectional scans will be performed of the femur, tibia and distal radius.

Timepoint [11]

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]

Lower limb power will be assessed by the 30 second Sit-to-Stand test (30STS).

Timepoint [12]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Changes in the global metabolite, proteome and lipidome as assessed by liquid chromatography-coupled tandem mass spectroscopy analysis.

Timepoint [17]

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]

Changes in habitual physical activity and sedentary behaviours, as assessed via accelerometery using an ActiGraph GT3X+ accelerometer.

Timepoint [18]

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]

Changes in habitual physical activity and sedentary behaviours, as assessed via self-recorded activity using the Godin Leisure-Time Exercise Questionnaire.

Timepoint [19]

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]

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]

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]

Level of concern about falls will be assessed using the Falls Self-Efficacy (FES) questionnaire.

Timepoint [21]

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]

Enjoyment of exercise sessions will be assessed by the Physical Activity Enjoyment Scale (PACES).

Timepoint [22]

Every four weeks during Stage 1.

Secondary outcome [23]

Anthropometry, including body mass, stature and waist and hip circumference, will be assessed.

Timepoint [23]

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]

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]

Data will be collected on a continual basis. Data will be analysed at 12 weeks, 24 weeks and 12 months.

Secondary outcome [25]

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]

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]

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]

At the conclusion of the study

Secondary outcome [27]

Changes in lower limb muscle strength will be assessed by the isometric mid-thigh pull

Timepoint [27]

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]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Greenslopes Private Hospital - Greenslopes

Recruitment hospital [2]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [3]

Royal Brisbane & Womens Hospital - Herston

Recruitment hospital [4]

North Lakes Health Precinct - North Lakes

Recruitment postcode(s) [1]

4120 - Greenslopes

Recruitment postcode(s) [2]

4102 - Woolloongabba

Recruitment postcode(s) [3]

4029 - Herston

Recruitment postcode(s) [4]

4509 - North Lakes

Funding & Sponsors

Funding source category [1]

University

Name [1]

The University of Queensland

Address [1]

School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia QLD 4072

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Brisbane Diamantina Health Partners

Address [2]

Translational Research Institute
37 Kent Street
Woolloongabba Queensland 4102

Country [2]

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]

Individual

Name [1]

Associate Professor Michelle Hill

Address [1]

Group Leader
Precision and Systems Biomedicine, QIMR Berghofer Medical Research Institute, Herston Road, Herston QLD 4006

Country [1]

Australia

Secondary sponsor category [2]

Individual

Name [2]

Jennifer Nicol

Address [2]

School of Human Movement and Nutrition Sciences (#26B), Cnr Blair Drive & Union Road, The University of Queensland, St Lucia QLD 4072

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Greenslopes Research and Ethics Committee

Ethics committee address [1]

Greenslopes Private Hospital
Newdegate Street
Greenslopes QLD 4120

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2018

Approval date [1]

13/12/2018

Ethics approval number [1]

18/58

Ethics committee name [2]

The University of Queensland Human Research Ethics Committees

Ethics committee address [2]

Cumbrae-Stewart Building #72
The University of Queensland
St Lucia QLD 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

20/12/2018

Approval date [2]

09/01/2019

Ethics approval number [2]

2018002644/18/58

Ethics committee name [3]

Metro South Human Research Ethics Committee

Ethics committee address [3]

Metro South Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

17/01/2019

Approval date [3]

27/03/2019

Ethics approval number [3]

HREC/2019/QMS/47400

Summary

Brief summary

This study will evaluate the effect of exercise on health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours in people with multiple myeloma.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above, have a diagnosis of multiple myeloma, and are free of any conditions that may prevent safe completion of the exercise demands of the study.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will immediately commence a 3 stage exercise program. The first stage will be gym-based and involves 2 x supervised sessions and 1 home-based session per week for 12 weeks. All supervised classes will be delivered by an Accredited Exercise Physiologist. Stage 2 is a 12 week home-based program (3 sessions/week) with weekly telephone support, with the option to attend one group-based class each week delivered by an Accredited Exercsie Physiologist. Stage 3 involves a maintenance home-based program for a further 6 months. The program will be individualised to the participants’ cardiorespiratory fitness and bone lesions, and will involve high-intensity aerobic exercise, resistance training and impact loading. Participants in the other group will receive the same program after a 12 week wait, during which time they will receive usual care.

All participants will undergo a number of assessments at baseline, 12 weeks, 24 weeks, 36 weeks (group 2 only) 12 months (group 1 only) and 15 months (group 2 only) in order to evaluate health-related quality of life, markers of disease progression, bone health, body composition, cardiovascular fitness, physical function and activity behaviours.
The potential findings of this proposed research will ultimately influence the inclusion of exercise as part of standard care to improve the health and longevity of people with multiple myeloma.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mrs Jennifer Nicol

Address

School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 409769373

Fax

[email protected]

Contact person for public queries

Name

Mrs Jennifer Nicol

Address

School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 409769373

Fax

[email protected]

Contact person for scientific queries

Name

Mrs Jennifer Nicol

Address

School of Human Movement and Nutrition Sciences (#26B)
Cnr Blair Drive & Union Road
The University of Queensland
St Lucia QLD 4072

Country

Australia

Phone

+61 409769373

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial.	2022	https://dx.doi.org/10.3390/curroncol29020077

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically