Exercise, Multiple Myeloma, Prehabilitation
Conditions
Brief 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. 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.
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.
Interventions
BEHAVIORALSupported Exercise
Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
BEHAVIORALStandard Care
Participants will receive standard care
Sponsors
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
An independent assessor will conduct the post-intervention assessment. The independent assessor will be blinded to group assignment.
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have a diagnosis of Multiple Myeloma 2. Be transplant eligible 3. Be undergoing chemotherapy prior to, or following an autologous stem cell transplant as part of their cancer treatment; or transplant ineligible. 4. Be an Alberta resident 5. Be ≥18 years of age 6. Be able to read and understand English.
Exclusion criteria
1. Their disease status/comorbidities preclude exercise testing or participation 2. 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 3. They do not have regular access to the internet and/or an electronic device in the home.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study completion rate | 10-weeks | The percentage of participants who complete the study, including the intervention and follow-up assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy Multiple Myeloma | 10 weeks | Health-related quality of life questionnaire: higher scores reflect better quality of life |
| Recruitment rate | 18 months | The percentage of participants who are eligible and consent to participate in the study. |
| Attendance rate | 18 months | The percentage of group and individual exercise sessions completed over the 10 weeks. |
| Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item) | 10 weeks | Fatigue questionnaire: higher scores reflect less fatigue |
| Body weight | 10 weeks | Weight measured in kilograms |
| Body height | 10 weeks | Weight measured in centimetres (to nearest 0.5 cm) |
| Grip Strength | 10 weeks | Hand grip measured in kilograms using a dynamometer |
| Calf muscle size | 10 weeks | Calf circumference measured in centimetres to the nearest 0.1 cm |
| Thigh muscle thickness | 10 weeks | Ultrasound measurement of rectus femoris muscle cross-sectional area |
| Short Physical Performance Battery | 10 weeks | Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand |
| Six-minute walk test | 10 weeks | Distance covered in metres (to nearest cm) in 6 minutes (hallway) |
| One leg stance balance | 10 weeks | Time standing on one foot (to a maximum of 45 seconds) |
| Shoulder flexion range of motion | 10 weeks | Upper limb flexibility measured in degrees |
| Edmonton Symptom Assessment System | 10 weeks | Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden |
| Sit and reach test | 10 weeks | Lower limb flexibility measured in cms (to nearest 0.5 cm) |
Countries
Canada
Contacts
CONTACTMargaret L McNeely, PhD
STUDY_DIRECTORChris Sellar, PhD
University of Alberta
Outcome results
None listed