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）会降低身体功能和肌肉质量并增加疲劳。 神经肌肉电刺激 (NMES) 作为独立干预措施时可改善肌肉 患有慢性阻塞性肺病和慢性心脏病的非癌症患者的力量和肌肉质量 使用 NMES 对抗废用性萎缩和功能衰退可能在 HCT 中特别有用。 当患者接受强化预备化疗并经常出现以下症状时 严重疲劳使他们在移植前后较长时间处于不活动或孤立状态。 然而，其在癌症治疗中的应用尚未得到充分证实。该提案将有助于这一点。 制定优化退伍军人 HCT 安全性和结果的策略 本研究的总体目标是评估 1) NMES 与 Sham 的疗效。 对 HCT 引起的身体功能和肌肉质量下降以及患者病情恶化进行干预 报告的疲劳和生活质量以及 2) 身体功能与患者长期康复之间的关联 报告疲劳和生活质量。我们认为 1) NMES 将减轻 HCT 引起的急性负面影响。 与假干预相比，对身体功能、身体成分、生活质量和疲劳的影响，以及 2) 基线 身体功能将是患者报告的疲劳 6 个月恢复和生活质量目标的重要预测指标。 1：为了确定 NMES 与 Sham 相比，对于减轻 HCT 引起的身体功能下降的功效， 接受自体 HCT 的患者的肌肉质量、患者报告的生活质量和疲劳程度。 按诊断随机 1:1（NMES：Sham）分层。 将在基线时进行评估（进入骨髓移植单位后但开始之前） 预备化疗）和 HCT 后 28±5 天（随访 1；FU1）。 与 Pre 相比，FU1 时 6MWT 变化的组间差异（N=23/组；总共 46 个次要结果）。 包括： 通过双能 X 射线吸收测定法测量的身体成分； （慢性病治疗疲劳的功能评估；肌肉和关节测量）评估患者- 报告疲劳、生活质量、症状负担和功能状态；护理标准临床/实验室数据 关于合并症、不良事件、住院治疗、治疗史、功能状态和临床 课程；以及 NMES 流程衡量指标，例如可行性、可接受性、会话次数、准确性等 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 关于身体功能延迟恢复、生活质量和疲劳、患者报告的结果、身体功能、 图表审查将在 HCT (FU2) 后 6 个月收集，Pre 将用于确定显着性。 通过先前验证的临床问卷评估，FU2 (N=46) 的 QOL 和疲劳预测因子。 从医疗图表中提取的措施将包括护理标准从 FU1 到 FU2 的变化 有关合并症、不良事件、住院、功能状态、治疗的临床/实验室数据 目标 3（探索性）：研究 NMES 与其他疾病的急性影响。 在 HCT 期间对身体功能的各个方面和患者报告的生活质量进行假手术，以确定潜力 未来临床试验的探索性功能测量（爬楼梯力量；肌肉力量；坐姿） Pre 和 FU1 评估的站立力；握力；峰值耗氧量）将用于确定 探索性 QOL 测量的重要预测因素（多维疲劳量表；简表 36； 欧洲癌症研究与治疗组织 QOL 问卷）评估为 FU2。