Neuromuscular Electrical Stimulation for Physical Function Maintenance during Hematopoietic Stem Cell Transplantation: Study Protocol
Overview
Hematopoietic stem cell transplantation (HCT) is a common treatment for blood cancers but can lead to long-term functional impairment, fatigue, and decreased quality of life. Traditional exercise is not consistently recommended or maintained by patients. This study aims to assess the effectiveness of neuromuscular electrical stimulation as an alternative rehabilitation strategy for HCT recipients.
Study Design
Patient enrolement in a randomized controlled trial with 1:1 (neuromuscular electrical stimulation:sham) design stratified by diagnosis and sex. Assessments are conducted prior to HCT and 24±5 days post-HCT (Follow-up 1), with additional assessments 6 months post-HCT (Follow-up 2). The primary outcome is the difference in 6-minute walk test change scores between the two groups.
Hypotheses
It is hypothesized that neuromuscular electrical stimulation will reduce adverse effects on physical function, muscle mass, quality of life, and fatigue compared to sham at Follow-up 1. Additionally, pre-transplant physical function is expected to significantly predict fatigue and quality of life at Follow-up 2.
Impact
This trial aims to improve patient care and quality of life by determining the efficacy and feasibility of neuromuscular electrical stimulation as a therapeutic strategy for HCT recipients. The trial is registered with clinicaltrials.gov (NCT04364256).
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