30 Participants Needed

Prehabilitation Program for Multiple Myeloma

SG
CU
AT
LM
NS
Overseen ByNoha Sharafeldin, MBBS PhD MSc
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Noha Mohamed Sharafeldin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This is a pilot feasibility trial among older adults (≥60y) scheduled to undergo Autologous Stem Cell transplantation at UAB. Participants will be randomized into either a prehabilitation program or an attention control group before their transplant. The primary outcomes will be feasibility and secondary outcomes include changes in physical function at the time of transplant and at 12 weeks follow up.

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 the trial coordinators or your doctor.

What data supports the effectiveness of the Prehabilitation Program for Multiple Myeloma treatment?

Research shows that exercise programs can help patients with multiple myeloma improve physical performance and reduce fatigue. Studies have also found that tailored exercise and lifestyle advice can increase physical activity and satisfaction among patients. Additionally, prehabilitation (exercise before treatment) has been effective in other diseases, suggesting potential benefits for multiple myeloma patients.12345

Is the Prehabilitation Program for Multiple Myeloma safe for humans?

Research shows that individualized exercise programs, which are part of prehabilitation, are generally safe for people with multiple myeloma, even though they have high rates of symptoms related to the disease and its treatment.25678

How is the Prehabilitation Program for Multiple Myeloma different from other treatments?

The Prehabilitation Program for Multiple Myeloma is unique because it focuses on preparing patients for stem-cell transplantation through a combination of dietary guidelines and a multi-modal exercise regimen, which is not typically part of standard myeloma treatments. This approach aims to improve patients' physical conditioning before treatment, potentially enhancing recovery and long-term health outcomes.24569

Eligibility Criteria

This trial is for individuals aged 60 or older who have been diagnosed with Multiple Myeloma and are scheduled to undergo Autologous Stem Cell Transplantation (ASCT) at UAB within the next 10 weeks. Those at high risk for imminent bone fractures as determined by Mirels score cannot participate.

Inclusion Criteria

I am scheduled for a stem cell transplant at UAB within 10 weeks of joining the study.
I have been diagnosed with Multiple Myeloma.
I am 60 years old or older and have had a stem cell transplant.

Exclusion Criteria

You have a high risk of breaking a bone based on a Mirels score.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation/Attention Control

Participants undergo an 8-week prehabilitation exercise program or receive nutrition counseling as an attention control

8 weeks
16 telehealth sessions (prehabilitation) or weekly phone calls (attention control)

Transplantation

Participants undergo Autologous Stem Cell Transplant

1 week

Follow-up

Participants are monitored for changes in physical function and other outcomes post-transplant

12 weeks
Assessments at baseline, post-intervention, and 12 weeks post-transplant

Treatment Details

Interventions

  • Dietary Guidelines
  • Multi-modal Exercise Regimen
Trial Overview The study is testing a prehabilitation program consisting of a multi-modal exercise regimen and dietary guidelines against an attention control group, to see if it's feasible and how it affects physical function before transplant and after 12 weeks.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: TeleprehabExperimental Treatment2 Interventions
The participants selected for the teleprehab arm will undergo a supervised 8-week multi-modal exercise program in a telehealth format (using doxy.me, a free telehealth platform) delivered by licensed physical or occupational therapists who have undergone cancer specific rehabilitation training within Select Medical's ReVital® cancer rehabilitation program. Participants will attend teleprehab sessions 2 times per week for a total of 16 sessions.
Group II: Attention ControlExperimental Treatment1 Intervention
The participants randomized to the attention control arm will not undergo an exercise regimen, but will be contacted by the study staff on the phone once a week..

Find a Clinic Near You

Who Is Running the Clinical Trial?

Noha Mohamed Sharafeldin

Lead Sponsor

Trials
1
Recruited
30+

Smith Giri

Lead Sponsor

Trials
1
Recruited
30+

Findings from Research

The PrISMS clinic, a multidisciplinary team approach for myeloma patients, significantly improved exercise levels and patient confidence in self-management, with 61 patients participating in 210 consultations.
The clinic was found to be safe and well-accepted by patients, indicating its potential to enhance quality of life and manage fatigue, warranting further research through randomized controlled trials.
High patient satisfaction and increased physical activity following a remote multidisciplinary team multiple myeloma clinic.Lecat, CSY., Fisher, A., Atta, M., et al.[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.
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 home-based exercise program for patients with multiple myeloma showed a high adherence rate of 75% over six months, indicating that such programs can be feasible even during intensive treatments like chemotherapy.
Patients who participated in the exercise program demonstrated improvements in physical performance, while those in the usual-care group experienced declines, highlighting the potential benefits of exercise for cancer patients.
Facilitating exercise adherence for patients with multiple myeloma.Coleman, EA., Hall-Barrow, J., Coon, S., et al.[2008]

References

High patient satisfaction and increased physical activity following a remote multidisciplinary team multiple myeloma clinic. [2023]
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]
Facilitating exercise adherence for patients with multiple myeloma. [2008]
A precision-based exercise program for patients with multiple myeloma. [2023]
Effects of exercise on fatigue, sleep, and performance: a randomized trial. [2021]
Exploring participant perceptions of a virtually supported home exercise program for people with multiple myeloma using a novel eHealth application: a qualitative study. [2023]
[Rehabilitation of patients with myeloma and marked locomotor disfunction]. [2008]
Safety, Feasibility, and Acceptability of a Multisite Individualized Exercise Intervention for People with Multiple Myeloma. [2023]
The Role of Exercise Before Cancer Treatment. [2022]
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