Multiple MyelomaMOTIVATENCT06280924
Prehab Prior to Stem Cell Transplantation in Multiple Myeloma
A study testing Supported Exercise in people with Multiple Myeloma and Exercise, run by University of Alberta at 1 site in Canada.
Trial summary
The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Exercise, Prehabilitation
- What is being tested?
- Supported Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2024to 31 Mar 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a diagnosis of Multiple Myeloma
- Be transplant eligible
- Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible.
- Be an Alberta resident
- Be ≥18 years of age
- Be able to read and understand English.
Who cannot join
- Their disease status/comorbidities preclude exercise testing or participation
- They are unable to commit to the 10-week exercise program and/or testing sessions at the Cancer Rehabilitation Clinic at the University of Alberta
- They do not have regular access to the internet and/or an electronic device in the home.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4
Margaret McNeely, PhD, 780-248-1531, mmcneely@ualberta.ca
Margaret L. McNeely, PhD
About this study
Official title: Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial
The primary purpose of this study is to see if individuals with Multiple Myeloma are able and interested in taking part in a tailored exercise program while undergoing their chemotherapy prior to a stem cell transplant. We also hope to learn if this type of program, along with a flexible delivery format (in-person and virtual), helps in maintaining or improving physical fitness, muscle mass and strength, and quality of life during chemotherapy.
Read the detailed description
MOTIVATE is a multi-methods feasibility randomized trial. We will recruit a minimum of 30 individuals with multiple myeloma who are undergoing chemotherapy prior to a Stem Cell Transplant. The study will be conducted in two phases:
Phase I: Feasibility Study The aim of this phase is to determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone.
Phase II: Qualitative Study The aim of this phase is to evaluate the acceptability of the Healthy Eating Active Living (HEAL-ME) app design, program delivery/design, and perceived effectiveness of the intervention at the level of the participant.
- Conditions
- Multiple Myeloma, Exercise, Prehabilitation
- Being tested
- Supported Exercise, Standard Care
- Medical subject headings
- Multiple Myeloma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supported ExerciseBehavioural
Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
Standard CareBehavioural
Participants will receive standard care
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Participants in this group will receive exercise counseling as per standard care for 10-weeks. This will include: (1) counseling on remaining active during chemotherapy; (2) handouts on the benefits of exercise during chemotherapy, exercise behavior change strategies, and how to exercise safely. Participants will be encouraged to remain as physical active as possible. As per American College of Sports Medicine 2019 guidelines, participants will be advised to take part in moderate intensity exercise for a total of 90 minutes per week. Receives: Behavioral: Standard Care |
| Supported Exercise Group | Experimental | Participants assigned to the exercise group will take part in a 10-week exercise program delivered in-person and through the HEAL-ME app. The program comprises (1) a minimum of one supervised session (in-person or virtual through a Zoom platform embedded in HEAL-ME), (2) a minimum of one independent exercise workout within the HEAL-ME app, and (3) exercise specific education content as per standard care. Receives: Behavioral: Supported Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study completion rate
The percentage of participants who complete the study, including the intervention and follow-up assessment
Measured: 10-weeks
Secondary outcomes (15)
Recruitment rate
The percentage of participants who are eligible and consent to participate in the study.
Measured: 18 months
Attendance rate
The percentage of group and individual exercise sessions completed over the 10 weeks.
Measured: 18 months
Edmonton Symptom Assessment System
Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden
Measured: 10 weeks
Functional Assessment of Cancer Therapy Multiple Myeloma
Health-related quality of life questionnaire: higher scores reflect better quality of life
Measured: 10 weeks
Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)
Fatigue questionnaire: higher scores reflect less fatigue
Measured: 10 weeks
Body weight
Weight measured in kilograms
Measured: 10 weeks
Body height
Weight measured in centimetres (to nearest 0.5 cm)
Measured: 10 weeks
Grip Strength
Hand grip measured in kilograms using a dynamometer
Measured: 10 weeks
Calf muscle size
Calf circumference measured in centimetres to the nearest 0.1 cm
Measured: 10 weeks
Thigh muscle thickness
Ultrasound measurement of rectus femoris muscle cross-sectional area
Measured: 10 weeks
Short Physical Performance Battery
Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand
Measured: 10 weeks
Six-minute walk test
Distance covered in metres (to nearest cm) in 6 minutes (hallway)
Measured: 10 weeks
One leg stance balance
Time standing on one foot (to a maximum of 45 seconds)
Measured: 10 weeks
Shoulder flexion range of motion
Upper limb flexibility measured in degrees
Measured: 10 weeks
Sit and reach test
Lower limb flexibility measured in cms (to nearest 0.5 cm)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start6 Aug 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chris Sellar, PhD, Study director, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280924
- Sponsor's protocol ID
- HREBA.CC-23-0220
- Acronym
- MOTIVATE
- Status last verified
- Oct 2026
- First submitted
- 19 Feb 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data generated or analyzed during this study will be available in the University of Alberta Dataserve repository