Summary
This research study aims to assess the efficacy of neuromuscular electrical stimulation (NMES) versus a sham intervention in attenuating physical function decline, muscle mass loss, and fatigue in Veterans undergoing hematopoietic cell transplantation (HCT). It also seeks to determine if baseline physical function predicts long-term recovery of fatigue and quality of life.
What they want
The study will randomize patients undergoing autologous HCT 1:1 to either NMES or a sham intervention. Physical function, body composition, quality of life (QOL), and fatigue will be assessed at baseline (Pre) and 28±5 days post-HCT (Follow-up 1; FU1). The primary outcome is the between-group difference in 6-minute walk test (6MWT) change at FU1 compared to Pre. Secondary outcomes include body composition via DEXA, patient-reported outcomes using validated questionnaires (FACT-Fatigue, Muscle and Joint Measures), and clinical/laboratory data. Additionally, NMES process measures like feasibility, acceptability, and adherence will be collected. A second aim will collect data at 6-months post-HCT (FU2) to determine the predictive ability of baseline 6MWT on delayed recovery of physical function, QOL, and fatigue, using questionnaires and medical chart review. An exploratory aim will investigate the acute impact of NMES vs. Sham on various physical function measures (stair climbing power, muscle strength, sit-to-stand, handgrip strength, peak oxygen consumption) and patient-reported QOL measures (MFI, SF-36, EORTC QOL Questionnaire) to identify potential endpoints for future clinical trials.
Deliverables
- Data on efficacy of NMES vs. Sham on HCT-induced reductions in physical function, muscle mass, fatigue, and QOL
- Data on the association between baseline physical function and 6-month recovery of patient-reported fatigue and QOL
- Analysis of NMES process measures (feasibility, acceptability, adherence, accurate use, duration/intensity, complications, satisfaction)
- Identification of potential endpoints for future clinical trials related to physical function and QOL during HCT
Technical requirements
- Dual-energy x-ray absorptiometry (DEXA) for body composition measurement
- Validated questionnaires for patient-reported outcomes (Functional Assessment of Chronic Illness Therapy-Fatigue; Muscle and Joint Measures; Multidimensional Fatigue Inventory; Short Form-36; European Organization for Research and Treatment of Cancer QOL Questionnaire)
- 6-minute walk test (6MWT)
- Clinical/laboratory data collection from standard of care
- Exploratory measures of function (stair climbing power, muscle strength, sit-to-stand, handgrip strength, peak oxygen consumption)
