Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

Multiple Myeloma Clinical Trial

— MOTIVATE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06280924
• Other study ID #: HREBA.CC-23-0220
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: June 2024
• Source: University of Alberta
• Contact: Margaret L McNeely, PhD
• Phone: 7802890972
• Email: mmcneely[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Prehabilitation

Intervention

Behavioral:
• Supported Exercise
Participants will take part in a prehabilitation exercise program prior to undergoing a stem cell transplant.
• Standard Care
Participants will receive standard care

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

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