Prehabilitation for Multiple Myeloma

(MOTIVATE Trial)

Overseen By Margaret L McNeely, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Disease status, Comorbidities, Internet access, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if individuals with Multiple Myeloma, a type of blood cancer, are willing and able to participate in a customized exercise program while undergoing chemotherapy. It will also assess whether this exercise routine, available both in-person and online, can maintain or improve physical fitness, muscle strength, and overall quality of life during treatment. Participants will be divided into two groups: one receiving standard exercise advice and the other following a guided exercise program (Supported Exercise). Individuals diagnosed with Multiple Myeloma, preparing for a stem cell transplant, and residing in Alberta may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance the quality of life for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on exercise during chemotherapy, so it's best to ask the trial coordinators for more details.

What prior data suggests that this exercise program is safe for individuals with Multiple Myeloma?

Research has shown that exercise programs for people with Multiple Myeloma are generally safe. One study found that a virtual, home-based exercise program improved strength and physical function without causing harm. Another study demonstrated that exercise therapy was safe and feasible for patients undergoing treatment. Reports highlight that participants adhered well to the exercise plans and experienced benefits such as improved muscle strength and fitness. Overall, these findings suggest that supported exercise is well-tolerated and can be safely included alongside standard cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the prehabilitation approach for multiple myeloma because it integrates supported exercise with standard care, offering a more holistic way to support patients during chemotherapy. Unlike the standard care, which focuses on exercise counseling, the supported exercise group includes both in-person and virtual supervised sessions through the HEAL-ME app, encouraging more consistent and personalized physical activity. This approach not only aims to improve physical fitness but also enhances patient engagement and education, potentially leading to better overall health outcomes during treatment.

What evidence suggests that this trial's treatments could be effective for Multiple Myeloma?

This trial will compare two exercise approaches for people with multiple myeloma. Participants in the Standard Care group will receive exercise counseling as per standard care, while those in the Supported Exercise Group will engage in a structured exercise program. Research has shown that exercise is both safe and beneficial for people with multiple myeloma. Studies suggest that exercise can enhance quality of life by reducing fatigue and pain. Exercise programs have been found to boost muscle strength, improve daily activities, and support mental well-being. Evidence also shows that exercise aids recovery after stem-cell transplants. Overall, patients often experience better health with regular exercise. ^{1 2 6 7 8}

Who Is on the Research Team?

Chris Sellar, PhD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Myeloma who are about to undergo chemotherapy and a stem cell transplant. Participants should be interested in following a tailored exercise program, which can be done both in-person and virtually.

Inclusion Criteria

Be an Alberta resident

Be transplant eligible

Be able to read and understand English

Exclusion Criteria

Do not have regular access to the internet and/or an electronic device in the home

My health conditions prevent me from doing exercise tests or activities.

I cannot commit to a 10-week exercise program at the University of Alberta.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Study

Determine the feasibility and preliminary effectiveness of a 10-week exercise intervention compared to physical activity counseling alone

10 weeks

Minimum of 1 supervised session (in-person or virtual), 1 independent exercise workout per week

Qualitative Study

Evaluate the acceptability of the HEAL-ME app design, program delivery/design, and perceived effectiveness of the intervention

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard Care
• Supported Exercise

Trial Overview

The study is testing whether a customized exercise regimen before stem cell transplantation can help maintain or improve physical fitness, muscle mass, strength, and quality of life during chemotherapy for Multiple Myeloma patients.

How Is the Trial Designed?

Group I: Supported Exercise Group Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

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.

Standard Care is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Varenicline for:

• Smoking cessation

Approved in European Union as Champix for:

• Smoking cessation

Approved in Canada as Champix for:

• Smoking cessation

Approved in Japan as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Published Research Related to This Trial

A prehabilitation exercise program for myeloma patients before autologous stem-cell transplantation (ASCT) was feasible, with 23 patients participating and a mean attendance of 75% for scheduled sessions, although only 62% completed the program.

Participants who completed the program showed significant improvements in their 6-minute walking distance, increasing from an average of 346 to 451 meters, and reported enhanced physical fitness and mental well-being, with no serious adverse events noted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and benefits of a structured prehabilitation programme prior to autologous stem cell transplantation (ASCT) in patients with myeloma; a prospective feasibility study. Mawson, S., Keen, C., Skilbeck, J., et al.[2022]

A 12-week study involving breast and colon cancer patients showed that while exercise interventions were safe and had good adherence among breast cancer patients (67% attendance), the overall cardio-respiratory fitness (VO2-peak) declined by an average of 12% during chemotherapy, raising questions about the effectiveness of aerobic exercise in this context.

The hospital-based exercise intervention showed some benefits in sustaining performance and reducing fat mass compared to the home-based pedometer intervention, but attendance was significantly lower for colon cancer patients (33%), indicating challenges in engaging this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The challenge of preserving cardiorespiratory fitness in physically inactive patients with colon or breast cancer during adjuvant chemotherapy: a randomised feasibility study. Møller, T., Lillelund, C., Andersen, C., et al.[2022]

Exercise prehabilitation is crucial for preparing cancer patients for treatments like surgery, with evidence supporting its role in improving fitness and strength, particularly through supervised moderate-intensity aerobic and resistance exercises.

Multimodal prehabilitation programs that include exercise, nutritional support, and psychological interventions are becoming standard practice, enhancing patient outcomes and adherence to treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Exercise Before Cancer Treatment. Denehy, L., Edbrooke, L.[2022]

A randomized trial involving 187 patients with newly diagnosed multiple myeloma found that a home-based individualized exercise program (HBIEP) did not significantly reduce fatigue, improve sleep, or enhance aerobic performance compared to usual care over a 15-week period.

Despite the minimal impact on fatigue and performance, the study suggests that exercise is safe for patients undergoing treatment for multiple myeloma and may provide physiological benefits, particularly in alleviating anemia when combined with epoetin alfa therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. Coleman, EA., Goodwin, JA., Kennedy, R., et al.[2021]

A study involving 50 patients undergoing preoperative treatment for pancreatic cancer found that social support and neighborhood walkability positively influenced their physical activity levels during treatment.

Patients reported that encouragement from healthcare providers and their motivation to complete treatment were key factors in adhering to home-based exercise prescriptions, highlighting the importance of interpersonal and environmental support in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supports and Barriers to Home-Based Physical Activity During Preoperative Treatment of Pancreatic Cancer: A Mixed-Methods Study. Parker, NH., Lee, RE., O'Connor, DP., et al.[2023]

A systematic review of 25 randomized-controlled trials involving 2682 cancer patients found that prehabilitation programs focusing on exercise training did not show clear benefits over usual care in improving health-related quality of life or reducing postoperative complications.

The overall certainty of the evidence was assessed as very low due to serious methodological concerns, indicating that more research is needed to determine the true effectiveness of prehabilitation programs for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation programs for individuals with cancer: a systematic review of randomized-controlled trials. Meneses-Echavez, JF., Loaiza-Betancur, AF., Díaz-López, V., et al.[2023]

A study involving 30 multiple myeloma patients showed that exercise therapy is safe and feasible, with no adverse events reported during the program.

Among those who adhered to the exercise regimen, significant improvements in physical functioning and a trend towards reduced fatigue were observed, suggesting that exercise may enhance quality of life for MM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. Wefelnberg, MM., Niels, T., Holtick, U., et al.[2023]

In a study of 41 multiple myeloma patients undergoing chemotherapy, 71% complied with exercise recommendations, leading to significant increases in exercise levels and decreases in fatigue severity.

Patients with a history of pathological fractures, spinal cord compression, or those who received radiation therapy were more likely to be noncompliant with exercise, indicating they may need extra support to engage in physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise compliance among patients with multiple myeloma undergoing chemotherapy: a retrospective study. Shallwani, S., Dalzell, MA., Sateren, W., et al.[2018]

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Prehabilitation for Multiple Myeloma (MOTIVATE Trial)

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Evidence supports the benefits of exercise-based rehabilitation in promoting recovery in myeloma patients following autologous stem-cell transplantation (ASCT).

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This clinical trial evaluates whether prehabilitation with aerobic and resistance exercise improves physical fitness and quality of life outcomes in older ...

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