Muscle Stimulation for Physical Function During Stem Cell Transplant

NCT04364256 | Completed DMC FDA Device

• 2 other identifiers: F3245-WIK2RX003245-03
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Autologous Hematopoietic Stem Cell Transplant

Keywords

neuromuscular electrical stimulation; physical function; hematologic cancer; muscle wasting; multiple myeloma; lymphoma; Hematopoietic Stem Cell Transplant; cancer cachexia; cancer rehabilitation

Outcome Measures

Primary Outcomes (1)

• 6-Minute Walk Test

  Manual and mobile application assessment

  change from before to 1month after transplant

Secondary Outcomes (12)

• Patient-reported Fatigue

  change from before to 1month after transplant

• Lean Body Mass

  change from before to 1month after transplant

• Physical Activity

  change from before to 1month after transplant

• NMES adherence

  1month after transplant

• Muscle Damage (safety)

  change from before to 2 weeks after intervention initiation

Study Arms (2)

Active NMES

ACTIVE COMPARATOR

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.

Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)

Sham NMES

SHAM COMPARATOR

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.

Device: RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)

Interventions

RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA) DEVICE

Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012

Also known as: NMES, e-stim

Active NMES; Sham NMES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adequate cognitive and language ability to provide consent
• Veteran enrolled in MTU at VAPSHCS for planned standard of care autologous HCT

You may not qualify if:

• active deep vein thrombosis or thrombophlebitis
• untreated hemorrhagic disorders
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108-1532, United States

Location

Related Publications (1)

• Anderson 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 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Muscular Atrophy; Multiple Myeloma; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases

Study Officials

• Lindsey J Anderson, PhD

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: During Informed Consent, patients will be instructed to not presume group assignment. An unblinded study coordinator will then randomize each participant to NMES:Sham on a 1:1 basis, stratifying by diagnosis. The unblinded coordinator will ensure each participant performs the appropriate NMES or Sham stimulus on each training day; stimulation will only occur in private exam rooms. NMES and Sham stimulators will be outwardly identical apart from a concealed "A" or "B" label indicating NMES or Sham device; the designation of A or B will only be known to the unblinded study coordinator, and not to the PI. The PI will administer all outcome assessments and conduct all statistical analyses; therefore the PI will remain blinded to NMES vs Sham group assignment until study completion. In the study database, group assignment will be coded as A or B, the PI will not know the coding of A or B. A document containing the coding will be kept in a different electronic location than the study folder.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Neuromuscular electrical stimulation (active vs sham signal)

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 28, 2020
• Study Start: May 14, 2021
• Primary Completion: September 30, 2025
• Study Completion: December 29, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)