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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supported Exercise | Behavioral | Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study completion rate | The percentage of participants who complete the study, including the intervention and follow-up assessment | 10-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | The percentage of participants who are eligible and consent to participate in the study. | 18 months |
| Attendance rate | The percentage of group and individual exercise sessions completed over the 10 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Margaret L McNeely, PhD | Contact | 7802890972 | mmcneely@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Chris Sellar, PhD | University of Alberta | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alberta/ Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 2G4 | Canada |
Data generated or analyzed during this study will be available in the University of Alberta Dataserve repository
Data will be deposited approximately one-year after completion of the study
Open access
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomized controlled trial
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An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.
| Standard Care | Behavioral | Participants will receive standard care |
|
| 18 months |
| Edmonton Symptom Assessment System | Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden | 10 weeks |
| Functional Assessment of Cancer Therapy Multiple Myeloma | Health-related quality of life questionnaire: higher scores reflect better quality of life | 10 weeks |
| Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item) | Fatigue questionnaire: higher scores reflect less fatigue | 10 weeks |
| Body weight | Weight measured in kilograms | 10 weeks |
| Body height | Weight measured in centimetres (to nearest 0.5 cm) | 10 weeks |
| Grip Strength | Hand grip measured in kilograms using a dynamometer | 10 weeks |
| Calf muscle size | Calf circumference measured in centimetres to the nearest 0.1 cm | 10 weeks |
| Thigh muscle thickness | Ultrasound measurement of rectus femoris muscle cross-sectional area | 10 weeks |
| Short Physical Performance Battery | Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand | 10 weeks |
| Six-minute walk test | Distance covered in metres (to nearest cm) in 6 minutes (hallway) | 10 weeks |
| One leg stance balance | Time standing on one foot (to a maximum of 45 seconds) | 10 weeks |
| Shoulder flexion range of motion | Upper limb flexibility measured in degrees | 10 weeks |
| Sit and reach test | Lower limb flexibility measured in cms (to nearest 0.5 cm) | 10 weeks |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001519 | Behavior |