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

• 批准号: 10213160
• 负责人: Lindsey Anderson
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 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/10213160
• 关键词: Acute; Adherence; Admission activity; Adverse event; African American; Aftercare; Attenuated; Autologous; Blood; Body Composition; Bone Marrow; Bone Marrow Transplantation; Chemotherapy and/or radiation; Chronic Disease; Chronic Lymphocytic Leukemia; Chronic Obstructive Airway Disease; Clinical; Clinical Trials; Congestive Heart Failure; Data; Diagnosis; 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' s Lymphoma; Oxygen Consumption; Patient Outcomes Assessments; Patients; Physical Function; Physical activity; Physical therapy; Population; Process Measure; Quality of life; Questionnaires; Randomized; Recording of previous events; Recovery; Reporting; Symptoms; Testing; Time; Transplantation; Veterans; Walking; agent orange; attenuation; cancer therapy; chemotherapy; clinical care; combat; common treatment; comorbidity; deconditioning; 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; safety outcomes; sarcopenia; satisfaction; secondary outcome; sedentary; sedentary lifestyle; side effect; standard of care

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.

造血细胞移植（HCT）减少身体功能和肌肉质量，并增加疲劳。 神经肌肉电刺激（NME）用作独立干预时，可以改善肌肉 慢性阻塞性肺疾病和慢性心脏的非癌症患者的力量和肌肉质量 失败。使用NME来打击废弃萎缩和功能下降可能在HCT中特别有用 当患者接受强化准备化疗，并经常出现症状，包括 严重的疲劳，使它们在移植周围的延长时间内使它们无活跃或孤立。 但是，它在癌症的环境中的使用尚未建立良好。该提议将有助于 制定策略，以优化与退伍军人相关的安全性和结果 血液学恶性肿瘤。这项研究的总体目标是评估1）NMES与Sham的效率 干预HCT引起的身体功能和肌肉质量的减少以及患者的担心 报道了疲劳和QOL，以及2）身体机能与患者长期恢复之间的关联 - 据报道疲劳和QOL。我们假设1）NME会衰减急性HCT诱导的负面影响 与假干预相比，关于身体功能，身体成分，QOL和疲劳，2）基线 身体功能将是患者报告的疲劳和QOL 6个月恢复的重要预测指标。目的 1：确定NMES与假手术的效率，以减少HCT诱导的身体机能降低， 接受自体HCT的患者的肌肉质量以及患者报告的QOL和疲劳。患者会 随机1：1（NME：假）通过诊断分层。身体功能，身体成分，生活质量和疲劳 将在基线时进行评估（前，入院后， 制备化疗）和HCT后28±5天（随访1; FU1）。主要结果将是 与PRE（n = 23/组;总计46）相比，FU1时6MWT变化的组间差异。次要结果 包括：通过双能量X射线绝对过肽测定法测量的身体组成；先前已验证的问卷 （对慢性病治疗的功能评估；肌肉和关节措施）评估患者 据报道疲劳，QOL，症状伯恩和功能状态；护理标准临床/实验室数据 有关的合并症，不良事件，住院，治疗病史，功能状况和临床 课程;和NME的过程度量，例如可行性，可接受性，会话次数，准确 使用，持续时间/强度，并发症和满意度。目标2：确定基线的预测能力 6MWT关于身体机能，QOL和疲劳的延迟恢复，患者报告的结果，身体功能， HCT（FU2）后6个月将收集图表审查。 PRE的6MWT将用于确定重要 通过先前验证的问卷评估，FU2（n = 46）的QOL和疲劳的预测因素。临床 从医疗图表中提取的措施将包括从FU1到FU2的更改 有关合并症，不良事件，住院，功能状况，治疗的临床/实验室数据 病史，疾病轨迹和生存。 AIM 3（探索性）：研究NMES与NMES的急性影响。 在HCT期间在身体机能的各个方面和患者报告的QOL中进行假手术，以确定潜力 未来临床试验的终点。功能的探索性措施（楼梯攀爬能力；肌肉力量； 托而手工束强度；在Pre和Fu1中评估的峰值消耗量）将用于确定 探索性QOL测量值的重要预测指标（多维疲劳清单；短表格-36； FU2评估的欧洲癌症研究和治疗组织。