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Neuromuscular electrical stimulation for physical function maintenance during hematopoietic stem cell transplantation

造血干细胞移植过程中神经肌肉电刺激维持身体功能

基本信息

批准号：
10710385
负责人：
Lindsey Anderson
金额：
--
依托单位：
VA PUGET SOUND HEALTHCARE SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-10-01 至 2025-09-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10710385
关键词：
Acute Adherence Admission activity Adverse event African American Aftercare Attenuated Autologous Blood Body Composition Bone Marrow Bone Marrow Transplantation Chronic Disease Chronic Lymphocytic Leukemia Chronic Obstructive Pulmonary Disease Chronic pulmonary heart disease Clinical Clinical Trials Congestive Heart Failure Data Diagnosis Dimensions Disease Disuse Atrophy Dual-Energy X-Ray Absorptiometry Equipment and supply inventories Ethnic Origin European Organization for Research and Treatment of Cancer Exercise Exposure to Fatigue Future Goals Hematologic Neoplasms Hematology Hematopoietic Stem Cell Transplantation Hodgkin Disease Hospitalization Infection Intervention Joints Laboratories Lead Leg Long-Term Effects Lymphatic Maintenance Malignant Neoplasms Measures Medical Multiple Myeloma Muscle Muscular Atrophy Nausea Non-Hodgkin&apos s Lymphoma Outcome Oxygen Consumption Patient Outcomes Assessments Patients Physical Function Physical activity Physical therapy Population Process Measure Quality of life Questionnaires Radiation Randomized Recommendation Recording of previous events Recovery Reporting Safety Symptoms Testing Time Transplantation Veterans Walking agent orange attenuation cancer therapy chemotherapy clinical care combat common treatment comorbidity deconditioning efficacy evaluation experience follow-up functional decline functional outcomes functional status hematopoietic cell transplantation improved muscle form muscle strength neuromuscular stimulation prevent primary outcome reduced muscle mass sarcopenia satisfaction secondary outcome sedentary sedentary lifestyle side effect standard of care

项目摘要

Hematopoietic cell transplantation (HCT) reduces physical function and muscle mass and increases fatigue. Neuromuscular electrical stimulation (NMES), when used as a stand-alone intervention, improves muscle strength and muscle mass in non-cancer patients with chronic obstructive pulmonary disease and chronic heart failure. The use of NMES to combat disuse atrophy and functional decline may be particularly useful in the HCT setting as patients undergo intensive preparatory chemotherapy and often experience symptoms including severe fatigue that leave them inactive or isolated for extended time periods surrounding the transplant. However, its use in the setting of cancer has not been well-established. This proposal will contribute to developing strategies toward optimizing the safety and outcomes associated with HCT in Veterans with hematologic malignancies. The overall goals of this study are to assess 1) the efficacy of an NMES vs Sham intervention on HCT-induced reductions in physical function and muscle mass and worsening of patient- reported fatigue and QOL and 2) the association between physical function and prolonged recovery of patient- reported fatigue and QOL. We hypothesize that 1) NMES will attenuate the acute HCT-induced negative impact on physical function, body composition, QOL, and fatigue compared to Sham intervention, and 2) baseline physical function will be a significant predictor of 6-month recovery of patient-reported fatigue and QOL. Aim 1: To determine the efficacy of NMES vs. Sham for attenuation of HCT-induced reductions in physical function, muscle mass, and patient-reported QOL and fatigue in patients undergoing autologous HCT. Patients will be randomized 1:1 (NMES:Sham) stratified by diagnosis. Physical function, body composition, QOL, and fatigue will be assessed at baseline (Pre, after admission to the Bone Marrow Transplant Unit but before initiation of preparatory chemotherapy) and 28±5 days after HCT (Follow-up 1; FU1). The primary outcome will be between-group difference in 6MWT change at FU1 compared to Pre (N=23/group; 46 total). Secondary outcomes include: body composition measured by dual-energy x-ray absorptiometry; previously validated questionnaires (Functional Assessment of Chronic Illness Therapy-Fatigue; Muscle and Joint Measures) to assess patient- reported fatigue, QOL, symptom burden, and functional status; standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, treatment history, functional status, and clinical course; and NMES process measures such as feasibility, acceptability, adherence in number of sessions, accurate use, duration/intensity, complications, and satisfaction. Aim 2: To determine predictive ability of baseline 6MWT on delayed recovery of physical function, QOL, and fatigue, patient-reported outcomes, physical function, and chart review will be collected 6-months after HCT (FU2). 6MWT at Pre will be used to determine significant predictors of QOL and fatigue at FU2 (N=46) as assessed by previously validated questionnaires. Clinical measures extracted from medical charts will include changes from FU1 to FU2 in standard of care clinical/laboratory data regarding co-morbidities, adverse events, hospitalizations, functional status, treatment history, disease trajectory, and survival. Aim 3 (exploratory): To investigate the acute impact of NMES vs. Sham during HCT on various aspects of physical function and patient-reported QOL for determining potential endpoints for future clinical trials. Exploratory measures of function (stair climbing power; muscle strength; sit- to-stand; handgrip strength; peak oxygen consumption) assessed at Pre and FU1 will be used to determine significant predictors of exploratory QOL measures (Multidimensional Fatigue Inventory; Short Form-36; European Organization for Research and Treatment of Cancer QOL Questionnaire) assessed at FU2.