Full Title:

Multiple Myeloma Exercise Prehabilitation for Individuals Awaiting a Stem Cell Transplantation (MOTIVATE): A Randomized Controlled Feasibility Trial

Myeloma stage or condition:

Multiple Myeloma Exercise Prehabilitation

Study phase:

N/A

Summary/Purpose:

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.

Treatments:

Behavioral : Supported Exercise

Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.

Behavioral : Standard Care

Participants will receive standard care

Study Arms:

Active Comparator : Standard Care
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.

Experimental : Supported Exercise Group
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.

Study Type:

Interventional

Study Design:

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Randomized controlled trial

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.

Recruitment status:

Not yet recruiting

Eligibility criteria:

Inclusion Criteria:

1. Have a diagnosis of Multiple Myeloma 2. Be transplant eligible 3. Be undergoing chemotherapy prior to an autologous stem cell transplant as part of their cancer treatment 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.

Locations / Centres:

University of Alberta/ Cross Cancer Institute, Edmonton, Alberta – ()

Contacts:

Name: Margaret L McNeely, PhD
Phone: 7802890972
Email: [email protected]

Publications:

???

First posted:

2024-02-28

Actual start date:

April 15, 2024

Last updated:

2024-02-19

Estimated enrollment:

30

Estimated completion date:

2026-06-30

Estimated primary completion date:

2025-12-31

Condition:

Multiple Myeloma

Exercise

Prehabilitation

Gender:

All

Ages:

18 Years-N/A

Accepts healthy volunteers:

No

Listed location countries:

Canada

NCT number:

NCT06280924

Other study ID numbers:

HREBA.CC-23-0220

Has Data monitoring committee:

No

U.S. FDA-regulated product:

No

IPD Sharing Statement :

???

Responsible party:

Sponsor

Study sponsor:

lead_sponsor
University of Alberta
Other

Collaborators:

???

Investigators:

Chris Sellar, PhD University of Alberta

Protocol Registration and Results System:

???

Verification date:

2024-02-01