Health Through Activity Program for Multiple Myeloma

Overseen By Kathleen Lyons, ScD, OTR/L

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MGH Institute of Health Professions

Disqualifiers: Bone pain, Fracture, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to explore whether a structured program can help reduce the challenges of decreased physical functioning and quality of life for participants with multiple myeloma by providing a customized exercise program and fostering engagement in meaningful activities. The name of the study intervention involved in this study is: Health Through Activity (HTA) (six-session, rehabilitation exercise regimen)

Do I have to stop taking my current medications for the trial?

The trial does not specify whether you need to stop taking your current medications. However, since participants must be currently receiving maintenance therapy for multiple myeloma, it seems likely that you can continue your existing treatment.

What data supports the effectiveness of the Health Through Activity treatment for multiple myeloma?

Research suggests that exercise programs can help improve quality of life and reduce fatigue in people with multiple myeloma. Studies have shown that individualized exercise interventions can enhance physical performance and health-related quality of life, which are important for managing symptoms of multiple myeloma. ^{1 2 3 4 5}

Is the Health Through Activity Program safe for people with multiple myeloma?

Research shows that exercise programs for people with multiple myeloma are generally safe, with no serious adverse events reported and only a few minor issues. This suggests that participating in such programs is unlikely to cause harm. ^{1 4 6 7 8}

How is the Health Through Activity treatment different from other treatments for multiple myeloma?

The Health Through Activity treatment is unique because it focuses on increasing physical activity to help manage multiple myeloma, unlike traditional treatments that primarily involve medication or chemotherapy. This approach aims to alleviate symptoms and improve quality of life by encouraging exercise, which is often underutilized in multiple myeloma care. ^{1 8 9 10 11}

Research Team

Kathleen Lyons, ScD, OTR/L

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with multiple myeloma who are on maintenance therapy and find their daily or social activities limited by health problems. It's not suitable for those with new or uncontrolled bone pain, recent fractures without repair, conditions preventing safe exercise, or moderate to severe cognitive impairment.

Inclusion Criteria

I am currently on maintenance therapy for multiple myeloma.

My health issues prevent me from doing daily or social activities.

Exclusion Criteria

I had a bone break in the last year that didn't need surgery.

I have new or worsening bone pain that greatly affects my daily life.

I don't have any health issues that prevent me from safely exercising.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 months

Treatment

Participants undergo the Health Through Activity (HTA) program, which includes a six-session rehabilitation exercise regimen

6 weeks

6 weekly visits (in-person)

Follow-up

Participants complete a Satisfaction survey and an individual, semi-structured interview to provide feedback about the program

Up to 4 months

Treatment Details

Interventions

• Health Through Activity (HTA)

Trial Overview The study tests the 'Health Through Activity' program, which includes a six-session rehabilitation exercise regimen designed to improve physical function and quality of life in people living with multiple myeloma.

Participant Groups

Group I: Health Through Activity (HTA) Intervention Experimental Treatment 1 Intervention

Participants will undergo study procedures as outlined: * Complete a baseline survey regarding activity level and quality of life. * Attend 6 weekly study visits at the MGH Institute of Health Professions IMPACT Practice Center. * Attend final study visit and complete the Satisfaction survey and an individual, semi-structured interview with site staff to supply feedback about the program. * After six weeks, complete the Satisfaction survey again.

Who Is Running the Clinical Trial?

MGH Institute of Health Professions

Lead Sponsor

Trials

19

Recruited

2,200+

Findings from Research

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]

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]

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]

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]

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]

References

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

STEPS to Enhance Physical Activity After Hematopoietic Cell Transplantation for Multiple Myeloma. [2022]

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

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

3. Austria pubmed.ncbi.nlm.nih.gov

Relevant parameters for recommendations of physical activity in patients suffering from multiple myeloma : A pilot study. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Physical Activity Preferences for People Living With Multiple Myeloma: A Qualitative Study. [2018]

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

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

10. England pubmed.ncbi.nlm.nih.gov

Multiple myeloma and physical activity: a scoping review. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Clinical exercise therapy program with multiple myeloma patients: Impacts on feasibility, adherence and efficacy. [2023]