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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
30
Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
Participants will receive standard care
University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, Canada
RECRUITINGStudy completion rate
The percentage of participants who complete the study, including the intervention and follow-up assessment
Time frame: 10-weeks
Recruitment rate
The percentage of participants who are eligible and consent to participate in the study.
Time frame: 18 months
Attendance rate
The percentage of group and individual exercise sessions completed over the 10 weeks.
Time frame: 18 months
Edmonton Symptom Assessment System
Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden
Time frame: 10 weeks
Functional Assessment of Cancer Therapy Multiple Myeloma
Health-related quality of life questionnaire: higher scores reflect better quality of life
Time frame: 10 weeks
Functional Assessment of Cancer Therapy: Fatigue Subscale (13-item)
Fatigue questionnaire: higher scores reflect less fatigue
Time frame: 10 weeks
Body weight
Weight measured in kilograms
Time frame: 10 weeks
Body height
Weight measured in centimetres (to nearest 0.5 cm)
Time frame: 10 weeks
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Grip Strength
Hand grip measured in kilograms using a dynamometer
Time frame: 10 weeks
Calf muscle size
Calf circumference measured in centimetres to the nearest 0.1 cm
Time frame: 10 weeks
Thigh muscle thickness
Ultrasound measurement of rectus femoris muscle cross-sectional area
Time frame: 10 weeks
Short Physical Performance Battery
Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand
Time frame: 10 weeks
Six-minute walk test
Distance covered in metres (to nearest cm) in 6 minutes (hallway)
Time frame: 10 weeks
One leg stance balance
Time standing on one foot (to a maximum of 45 seconds)
Time frame: 10 weeks
Shoulder flexion range of motion
Upper limb flexibility measured in degrees
Time frame: 10 weeks
Sit and reach test
Lower limb flexibility measured in cms (to nearest 0.5 cm)
Time frame: 10 weeks