Prehabilitation Exercise for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Christina Dieli-Conwright, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Unstable angina, Spinal instability, Recent surgery, others

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

Compensation: Varies

Number of Visits: 6

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an 8-week, home-based exercise program (PARE) can improve strength and health outcomes for people with multiple myeloma before they undergo a stem cell transplant. Participants will be divided into two groups: one will follow the exercise program, while the other will continue their usual activities. The goal is to determine if the exercise program boosts muscle strength and overall health more effectively than regular activities. This trial is ideal for those diagnosed with multiple myeloma who are awaiting their first stem cell transplant and currently engage in less than an hour of structured exercise each week. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance pre-transplant care for multiple myeloma 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's best to discuss this with your doctor or the study team.

What prior data suggests that this prehabilitation exercise program is safe for multiple myeloma patients?

Research has shown that prehabilitation exercise programs, such as the PARE program, are safe for participants. Previous studies found no harmful effects from aerobic and resistance exercises. These exercises are especially safe following an autologous stem cell transplant (ASCT). Thus, the exercises in this study are generally well-tolerated and unlikely to cause harm. Participants can expect a safe experience with the program, focusing on improving strength and health without safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Prehabilitation Exercise for Multiple Myeloma (PARE) because it focuses on enhancing patients' physical strength before they undergo Autologous Stem Cell Transplantation (ASCT). Unlike traditional treatments for multiple myeloma, which often involve chemotherapy and stem cell transplants, this approach emphasizes prehabilitation through a structured exercise program. The PARE method is unique in its use of virtually supervised aerobic and resistance exercises, which patients can do at home with the help of study-provided equipment. This could potentially improve patients' fitness and recovery outcomes, setting it apart from typical care strategies that don't prioritize physical conditioning before treatment.

What evidence suggests that this prehabilitation exercise program is effective for multiple myeloma?

Research shows that exercise can benefit people with multiple myeloma, a type of cancer. In this trial, participants in the Exercise Group (PARE) will engage in regular aerobic and strength exercises. Studies have shown these exercises help patients become stronger and improve their physical abilities. Participants perform these exercises at home with guidance from a trainer. Many patients report feeling better and having more energy after exercising. The American College of Sports Medicine recommends about 150 minutes of exercise each week for health benefits. Early research indicates that exercising before treatments like stem cell transplants might improve health outcomes. Meanwhile, participants in the Waitlist Control Group will continue with normal daily activities and may join the PARE exercise program after the study concludes. ^{1 2 3 4 6}

Who Is on the Research Team?

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma who are on the autologous stem cell transplant waiting list at Dana-Farber Cancer Institute. They must exercise less than 60 minutes per week, be able to travel for data collection, and women must use contraception. Exclusions include unstable heart conditions, inability to comply with study requirements, spinal issues preventing exercise, other active cancers needing treatment.

Inclusion Criteria

I am over 18 years old.

Women of child-bearing potential must agree to undergo a pregnancy test and to use adequate contraception prior to study entry and for six months following duration of study participation

I have multiple myeloma and am on the waiting list for my first stem cell transplant.

Exclusion Criteria

Deemed unsuitable to partake by the transplant or study team

I have a health condition that could worsen with exercise, as advised by my doctor.

I have had spinal surgery or surgery for broken bones due to disease within the last six weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation Exercise Training

Participants undergo an 8-week virtually supervised aerobic and resistance exercise program at home

8 weeks

3 visits (clinic) at week 1, week 10, and 30 days post-ASCT

Waitlist Control

Participants continue with normal daily activities for 8 weeks with an option to participate in the exercise program after study completion

8 weeks

3-5 visits (clinic)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including evaluations of muscle strength, cardiorespiratory fitness, and body composition

up to 9 months

What Are the Treatments Tested in This Trial?

Interventions

• PARE
• Waitlist Control Group

Trial Overview The study tests if an 8-week virtual home-based aerobic and resistance exercise program (PARE) before autologous stem cell transplantation can improve muscle strength, physical capacity, patient outcomes, and cardiometabolic health compared to a waitlist control group continuing normal activities.

How Is the Trial Designed?

Group I: Exercise Group (PARE) Experimental Treatment 1 Intervention

Participants will be randomly assigned to the Exercise Group (PARE) and will complete study procedures as outlined: * 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance equipment, heart-rate monitor, and a wi-fi enabled tablet. * Clinic visits at week 1, week 10, and 30 days post Autologous Stem Cell Transplantation (ASCT). * Questionnaires and surveys.

Group II: Waitlist Control Group Active Control 1 Intervention

Participants will be randomly assigned to the Waitlist Control Group and will complete study procedures as outlined: * 8 weeks of continuing with normal daily activities. * Option to participate in PARE exercise program after study completion. * 3 clinic visits with option of 5 visits. The two additional visits are for evaluation and testing for those who choose to participate in exercise program after study completion.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

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]

A systematic review of five randomized controlled trials involving 519 adults with multiple myeloma found that exercise interventions did not improve overall quality of life, indicating that exercise may not be beneficial in this context.

Interestingly, the exercise interventions were associated with a decrease in grip strength, suggesting that they may have negative effects on certain physical capabilities, highlighting the need for further high-quality research to better understand the impact of exercise on this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of exercise interventions on quality of life in patients with multiple myeloma: a systematic review and meta-analysis of randomised controlled trials. Goodhew, RE., Edwards, BA.[2023]

This study aims to assess the feasibility of conducting a randomized controlled trial on prehabilitation exercise for patients with multiple myeloma awaiting autologous stem-cell transplantation, focusing on recruitment, adherence, and safety.

The intervention involves six weeks of individualized, supervised exercise, with outcomes measured through walking distance and quality of life, highlighting the potential benefits of exercise in improving recovery for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is it feasible to conduct a randomised controlled trial of pretransplant exercise (prehabilitation) for patients with multiple myeloma awaiting autologous haematopoietic stem cell transplantation? Protocol for the PREeMPT study. Keen, C., Skilbeck, J., Ross, H., et al.[2021]

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 survey of 34 clinical haematologists revealed that while 97% recognize the importance of physical activity (PA) for multiple myeloma patients, many lack confidence in providing specific exercise recommendations or identifying resources.

Despite acknowledging the benefits of PA for quality of life and mental health, 44% of haematologists do not refer patients to exercise professionals, indicating a need for better support and clearer referral pathways to enhance patient access to exercise guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. Nicol, JL., Hill, MM., Burton, NW., et al.[2022]

Only 12% of people with multiple myeloma (MM) remained physically active after treatment, highlighting a significant drop in activity levels post-diagnosis, especially among those who were not active before their diagnosis.

The study found that 55% of respondents expressed interest in low-cost, flexible exercise programs supervised by specialists, indicating a need for accessible physical activity options to help improve their health and manage symptoms during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. Nicol, JL., Woodrow, C., Burton, NW., et al.[2020]

Exercise programs for people with multiple myeloma (MM) are safe, with no serious adverse events reported and high attendance rates (58% to 96%) across seven studies involving 563 participants.

While exercise did not significantly improve fatigue, depression, or quality of life, it did show some benefits in physical performance measures, such as increased lower limb strength and peak oxygen uptake, suggesting potential for enhancing physical health in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Efficacy of Exercise Interventions for People With Multiple Myeloma: A Systematic Review. Nicol, JL., Chong, JE., McQuilten, ZK., et al.[2023]

The individualized, high-intensity exercise program for people with multiple myeloma (MM) was found to be safe, with no adverse events reported during the 12-week trial involving 60 participants.

The program showed high acceptability among participants (82% enjoyment), although adherence to the exercise protocols was limited, indicating a need for strategies to enhance participation, especially in unsupervised sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Acceptability of a Multisite Individualized Exercise Intervention for People with Multiple Myeloma. Nicol, JL., Cunningham, BJ., Woodrow, C., et al.[2023]

This trial will assess the impact of a 12-week exercise intervention on health-related quality of life (HRQoL) in 60 patients with multiple myeloma, a cancer known for causing significant bone pain and lesions.

The study will also evaluate secondary outcomes such as bone health, fatigue, and muscle strength, aiming to determine if exercise should be integrated into standard care for improving overall health in multiple myeloma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial. Nicol, JL., Woodrow, C., Cunningham, BJ., et al.[2022]

Patients with multiple myeloma generally believe that exercise is beneficial and would recommend it to others undergoing similar treatments, indicating a positive perception of exercise as part of their care.

The study highlights that patients' adherence to exercise programs during aggressive treatment is influenced by their personal beliefs and social contexts, suggesting that clinicians should consider these factors to enhance patient engagement in exercise interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keep moving: patients with myeloma talk about exercise and fatigue. Coon, SK., Coleman, EA.[2006]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05706766

Prehabilitation Exercise Training in Multiple Myeloma ... 8 weeks of 3x weekly sessions of virtually supervised aerobic and resistance exercise performed at home using study-provided stationary bike, resistance ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11695955/

Prehabilitation Exercise Training to Target Improved ... Patients with multiple myeloma who participate in the ~150 minutes of exercise, as recommended by the American College of Sports Medicine [8,9], experience ...

3. dana-farber.org dana-farber.org/clinical-trials/22-403

Prehabilitation Exercise Training in Multiple Myeloma ... The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-02679

Prehabilitation Aerobic and Resistance Exercise Training ... This clinical trial tests the effect of prehabilitation aerobic and resistance exercise (PARE) on muscular strength, physical capacity, physical function ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/?otool=iaufhhslib&term=39701583

Prehabilitation Exercise Training to Target Improved Muscle ... The 8-week exercise intervention is home-based and digitally supervised by a clinical exercise trainer. The frequency of the exercise ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04484714

NCT04484714 | Virtual Exercise for Multiple Myeloma The main objective of this study is to determine the safety and feasibility of a 12-week virtually supported home-based aerobic and resistance exercise program ...