Telehealth Exercise for Multiple Myeloma

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Cardiovascular disease, Exercise contraindications, Recent injury, others

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

Compensation: Varies

Number of Visits: 6

Duration: 8 weeks

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a telehealth exercise program for multiple myeloma survivors. The program uses videos to guide patients through various exercises to improve their strength and physical function. The goal is to help these patients feel stronger and less frail by engaging in regular physical activity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the Telehealth Exercise Intervention treatment for multiple myeloma?

Research suggests that telehealth exercise programs can improve physical function and reduce frailty in multiple myeloma patients, especially those undergoing stem cell transplantation. These programs offer the benefits of personalized exercise plans and supervision, which are important for managing the side effects of multiple myeloma. ^{1 2 3 4 5}

Is telehealth exercise safe for people with multiple myeloma?

Research shows that telehealth exercise programs are generally safe for people with multiple myeloma, with no serious adverse events reported in studies. Some minor adverse events were noted, but overall, exercise interventions were well-tolerated. ^{1 2 3 6 7}

How is the Telehealth Exercise Intervention treatment different from other treatments for multiple myeloma?

The Telehealth Exercise Intervention is unique because it combines the benefits of personalized, supervised exercise programs with the convenience of home-based flexibility through virtual support. This approach addresses the challenges of traditional exercise programs, such as fixed schedules and travel, making it more accessible and safer for patients with multiple myeloma who are at risk of physical dysfunction and frailty. ^{1 2 3 8 9}

Research Team

Kyuwan Lee

Principal Investigator

City of Hope Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults diagnosed with multiple myeloma who are pre-frail or frail, have had a stem cell transplant within the last 30-180 days, and can perform study tasks. They must not have serious heart issues, exercise contraindications like infections or unstable bone lesions, recent injuries affecting exercise ability, or be doing regular intense exercise.

Inclusion Criteria

I am considered pre-frail or frail based on my weight, energy, walking speed, and muscle strength.

I am willing and able to follow all study requirements.

I have been diagnosed with multiple myeloma.

Exclusion Criteria

I am pregnant or planning to become pregnant.

You should not participate if you have a current infection or unstable bone problems that make it unsafe to exercise.

I am recovering from an injury that makes rigorous exercise difficult.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual)

Treatment

Participants undergo a home-based exercise program 3 times per week for 8 weeks

8 weeks

3 sessions per week (virtual)

Follow-up

Participants are monitored for sustainability of the intervention on physical function and frailty

9 weeks

2 assessments (virtual) at weeks 9 and 17

Treatment Details

Interventions

• Telehealth Exercise Intervention

Trial Overview The study tests a telehealth-based exercise program aimed at improving physical function and reducing frailty in multiple myeloma survivors. Participants will follow online videos for exercises focusing on coordination, posture, stretching, balance, and resistance/cardio training.

Participant Groups

Group I: Arm A (home-based exercise program) Experimental Treatment 3 Interventions

Patients undergo home-based exercise program 3 times per week for 8 weeks. Patients complete questionnaires at baseline (before 1 week) and at weeks 9 and 17.

Group II: Arm B (current activities) Active Control 3 Interventions

Patients complete questionnaires at baseline and at week 9 and 17. Patients continue maintaining current activities of daily living and do not participate in any exercise program. Patients may then participate in home-based exercise program 3 times per week for 8 weeks.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A 12-week eHealth exercise program for people with multiple myeloma was found to be safe and feasible, with no serious adverse events reported and a high adherence rate of 90%.

Participants experienced significant improvements in quality of life and physical fitness, with 96% reporting the program as beneficial and 89% satisfied with the delivery through the HEAL-Me app.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a tailored and virtually supported home exercise program for people with multiple myeloma using a novel eHealth application. Purdy, GM., Venner, CP., Tandon, P., 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]

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]

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]

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 virtually supported exercise program for people with multiple myeloma was found to be acceptable, with positive feedback from 20 participants regarding its tailored and supportive nature.

Participants appreciated the diversity of exercise options and the user-friendly design of the accompanying eHealth app, although some components could be improved for better usability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring participant perceptions of a virtually supported home exercise program for people with multiple myeloma using a novel eHealth application: a qualitative study. Purdy, GM., Sobierajski, FM., Al Onazi, MM., et al.[2023]

References

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

Feasibility of a tailored and virtually supported home exercise program for people with multiple myeloma using a novel eHealth application. [2022]

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

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

3. England pubmed.ncbi.nlm.nih.gov

Telehealth exercise to Improve Physical function and frailty in patients with multiple myeloma treated with autologous hematopoietic Stem cell transplantation (TIPS): protocol of a randomized controlled trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Exercise prehabilitation for people with myeloma undergoing autologous stem cell transplantation: results from PERCEPT pilot randomised controlled trial. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

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

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. Germany pubmed.ncbi.nlm.nih.gov

Exploring participant perceptions of a virtually supported home exercise program for people with multiple myeloma using a novel eHealth application: a qualitative study. [2023]