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

Trial Summary

What is the purpose of this trial?

The goal of this research study is to investigate whether a virtual, home-based, prehabilitation aerobic and resistance exercise (PARE) training program implemented 8 weeks prior to receiving autologous stem cell transplant (ASCT) for multiple myeloma participants will improve muscular strength, physical capacity, patient reported outcomes, and cardiometabolic health outcomes. The names of the study interventions involved in this study are: * Prehabilitative aerobic and resistance exercise (PARE) (virtually supervised 8-week aerobic and resistance exercise program) * Waitlist control (8-week normal activity behavior)

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 data supports the effectiveness of the treatment PARE for multiple myeloma?

Research shows that exercise can improve the quality of life for people with multiple myeloma, and prehabilitation (exercise before treatment) has been effective in other diseases. Many patients with multiple myeloma are interested in exercise programs, especially if they are low-cost and supervised by specialists. ^{1 2 3 4 5}

Is prehabilitation exercise safe for people with multiple myeloma?

Exercise programs for people with multiple myeloma have been found to be safe, with no serious adverse events reported and only a few minor issues. This suggests that such exercise interventions are generally safe for humans. ^{2 6 7 8 9}

How is the PARE treatment different from other treatments for multiple myeloma?

The PARE treatment is unique because it involves a virtually supervised 8-week program of aerobic and resistance exercises designed to prepare patients for stem-cell transplantation, which is not a standard approach for multiple myeloma. This prehabilitation exercise aims to improve patients' physical condition before undergoing intensive treatment, potentially enhancing recovery and quality of life. ^{1 3 5 7 10}

Research Team

Christina M Dieli-Conwright, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Promoting exercise for patients with multiple myeloma: attitudes and practices of clinical haematologists. [2022]

2. Italy 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Physical Activity in People with Multiple Myeloma: Associated Factors and Exercise Program Preferences. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Keep moving: patients with myeloma talk about exercise and fatigue. [2006]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Efficacy of Exercise Interventions for People With Multiple Myeloma: A Systematic Review. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

Exercise compliance among patients with multiple myeloma undergoing chemotherapy: a retrospective study. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Safety, Feasibility, and Acceptability of a Multisite Individualized Exercise Intervention for People with Multiple Myeloma. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

An Individualized Exercise Intervention for People with Multiple Myeloma-Study Protocol of a Randomized Waitlist-Controlled Trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]