Prehab Prior to Stem Cell Transplantation in Multiple Myeloma

Not Applicable

Recruiting

• Conditions: Exercise; Multiple Myeloma; Prehabilitation
• Interventions: Behavioral: Standard Care; Behavioral: Supported Exercise

• Registration Number: NCT06280924
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Status Verified: 2024-08
• Study Start: 2024-08-06
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	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.
Supported Exercise Group	Supported Exercise	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.

Primary Outcome Measures

Name	Time	Method
Study completion rate	10-weeks	The percentage of participants who complete the study, including the intervention and follow-up assessment

Secondary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy Multiple Myeloma	10 weeks	Health-related quality of life questionnaire: higher scores reflect better quality of life
Thigh muscle thickness	10 weeks	Ultrasound measurement of rectus femoris muscle cross-sectional area
Six-minute walk test	10 weeks	Distance covered in metres (to nearest cm) in 6 minutes (hallway)
Attendance rate	18 months	The percentage of group and individual exercise sessions completed over the 10 weeks.
Edmonton Symptom Assessment System	10 weeks	Tool to assess 11 symptoms related to cancer: higher scores reflect worse symptom burden
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
Shoulder flexion range of motion	10 weeks	Upper limb flexibility measured in degrees
Sit and reach test	10 weeks	Lower limb flexibility measured in cms (to nearest 0.5 cm)
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
Calf muscle size	10 weeks	Calf circumference measured in centimetres to the nearest 0.1 cm
Recruitment rate	18 months	The percentage of participants who are eligible and consent to participate in the study.
Short Physical Performance Battery	10 weeks	Test includes 4-meter timed walk, balance and 5-repetition sit-to-stand
One leg stance balance	10 weeks	Time standing on one foot (to a maximum of 45 seconds)

Trial Locations

Locations (1)

University of Alberta/ Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada