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Muscle Stimulation for Stem Cell Transplant Recovery

N/A

Recruiting

Led By Lindsey J Anderson, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT

Adequate cognitive and language ability to provide consent

Must not have

Untreated hemorrhagic disorders

History of rhabdomyolysis or other muscle conditions where NMES is contraindicated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from before to 1month after transplant

Summary

This trial is testing a new exercise strategy, neuromuscular electrical stimulation, to see if it can help reduce the long-term effects of cancer treatment, including deconditioning, fatigue, and muscle atrophy.

Who is the study for?

This trial is for Veterans planning to undergo autologous stem cell transplant at VAPSHCS and can consent. It's not for those with active blood clots, untreated bleeding disorders, muscle conditions that forbid electrical stimulation, heart devices, severe liver or kidney disease, previous stem cell transplants, or high baseline muscle soreness.

What is being tested?

The study tests neuromuscular electrical stimulation (NMES) using the RS-4i Plus Sequential Stimulator to maintain physical function and quality of life after a hematologic stem cell transplant. The goal is to see if NMES can help reduce deconditioning and fatigue from cancer treatment.

What are the potential side effects?

Potential side effects of NMES may include discomfort at the site of electrode placement, skin irritation under the electrodes, muscle soreness similar to what might be felt after exercise, and in rare cases excessive muscle fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a veteran enrolled for a stem cell transplant at VAPSHCS.

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I understand and can communicate my decision to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a bleeding disorder that hasn't been treated.

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I have never had rhabdomyolysis or muscle conditions that prevent NMES use.

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I am currently using anabolic agents.

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I currently have a deep vein clot or inflammation.

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I have had a stem cell transplant in the past.

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I have been diagnosed with liver cirrhosis.

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My kidney function is significantly reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from before to 1month after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from before to 1month after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from before to 1month after transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

6-Minute Walk Test

Lean Body Mass

Muscle Tissue

+3 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active NMESActive Control1 Intervention

asymmetric biphasic waveforms at 71 pulses per second frequency (Hz), 400 s pulse duration, 5:10s on:off time (50% duty cycle), and 1.5s ramp-up time. Participants will be in control of the muscle stimulator devices at all times and will be instructed to perform all sessions in the supine position. Bilateral NMES will be delivered via asymmetric, biphasic using four cutaneous parallel channels delivered simultaneously using 2"x4" or 3"x5" self-adhesive electrodes. For the active NMES group, participants will be encouraged to increase the amplitude to a level of moderate discomfort, such as that experienced during conventional exercise, but not to induce pain. At minimum, the amplitude should induce visible muscle contraction.

Group II: Sham NMESPlacebo Group1 Intervention

The amplitude of the muscle stimulators for the Sham group will be capped at 15 milliamperes so patients will only feel cutaneous sensation without achieving muscle contraction.

0 / 9Eligibility criteria met