University of Alberta/ Cross Cancer Institute
Edmonton, Alberta, T6G 2G4, Canada
Location status: Recruiting
Location contact
Margaret L. McNeely, PhD
PRINCIPAL_INVESTIGATOR
Margaret McNeely, PhD
CONTACT
NCT Number: NCT06280924
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Edmonton, Alberta, T6G 2G4, Canada
Location status: Recruiting
Margaret L. McNeely, PhD
PRINCIPAL_INVESTIGATOR
Margaret McNeely, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
Participants will receive standard care
Time frame: 10-weeks
The percentage of participants who complete the study, including the intervention and follow-up assessment
Time frame: 18 months
The percentage of participants who are eligible and consent to participate in the study.
Time frame: 18 months
The percentage of group and individual exercise sessions completed over the 10 weeks.
Time frame: 10 weeks
Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden
Time frame: 10 weeks
Health-related quality of life questionnaire: higher scores reflect better quality of life
Time frame: 10 weeks
Fatigue questionnaire: higher scores reflect less fatigue
Time frame: 10 weeks
Weight measured in kilograms
Time frame: 10 weeks
Weight measured in centimetres (to nearest 0.5 cm)
Time frame: 10 weeks
Hand grip measured in kilograms using a dynamometer
Time frame: 10 weeks
Calf circumference measured in centimetres to the nearest 0.1 cm
Time frame: 10 weeks
Ultrasound measurement of rectus femoris muscle cross-sectional area
Time frame: 10 weeks
Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand
Time frame: 10 weeks
Distance covered in metres (to nearest cm) in 6 minutes (hallway)
Time frame: 10 weeks
Time standing on one foot (to a maximum of 45 seconds)
Time frame: 10 weeks
Upper limb flexibility measured in degrees
Time frame: 10 weeks
Lower limb flexibility measured in cms (to nearest 0.5 cm)
Contact information is provided by the study sponsor or research team.
University of Alberta
Other
Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial
Acronym: MOTIVATE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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