Clinical trial · Interventional
Muscle Stimulation for Physical Function During Stem Cell Transplant
Neuromuscular Electrical Stimulation for Physical Function Maintenance During Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Some blood, bone marrow, and lymphatic (hematologic) cancers such as Hodgkin/Non-Hodgkin lymphomas, chronic lymphocytic leukemia, and multiple myeloma, are over-represented in Veterans due to exposures including Agent Orange and an increased percentage of patients of African American ethnicity. Hematologic transplantation (HCT) is a common treatment for these cancers, but often leads to deconditioning, fatigue, muscle atrophy, and poor quality of life, which are associated with complications such as hospitalization and infection. Despite the significance of these symptoms, there are no approved treatments to prevent/reverse these long-term effects. The cancer itself, side effects of chemotherapy, and sedentary behavior, contribute to these effects. Although exercise before and after HCT has helped reduce these effects, it is inconsistently recommended to patients and most remain sedentary through and after treatment. The investigators are testing an alternative exercise strategy, neuromuscular electrical stimulation, to maintain physical function quality of life after HCT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Active NMES
- description
- 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.
- interventionNames
- Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)
- type
- SHAM_COMPARATOR
- label
- Sham NMES
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * adequate cognitive and language ability to provide consent * Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT Exclusion Criteria: * active deep vein thrombosis or thrombophlebitis * untreated hemorrhagic disorders * concomitant study inclusion in other nutritional or physical exercise interventional trials * concomitant use of anabolic agents * rhabdomyolysis or other muscle conditions where NMES is contraindicated * implanted cardiac device * baseline patient-reported muscle soreness of 5-6 on the soreness likert scale that is unrelated to recent physical exertion * history of prior hematologic stem cell transplant * probable or definitive liver cirrhosis * reduced renal clearance defined as Stage 4 chronic kidney disease (glomerular filtration rate \<45 ml/min/1.73 m2)
References
Publications (1)
- DERIVEDAnderson LJ, Paulsen L, Miranda G, Syrjala KL, Graf SA, Chauncey TR, Garcia JM. Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation: Study protocol. PLoS One. 2024 May 10;19(5):e0302970. doi: 10.1371/journal.pone.0302970. eCollection 2024. PMID 38728244