Department of Physical Therapy, University of Florida, Gainesville, FL, United States.
Brooks Rehabilitation, Jacksonville, FL, United States.
JMIR Res Protoc. 2024 Nov 27;13:e59749. doi: 10.2196/59749.
BACKGROUND: Persistent disability in chronic stroke survivors is often attributed to arm or leg weakness; however, respiratory muscle weakness also impedes poststroke rehabilitation, reduces quality of life, and increases the risk of health complications. Respiratory complications are common after stroke and place patients at risk for both prolonged functional disability and mortality. In addition, stroke survivors face ongoing cardiovascular disease that places them at risk for recurrent stroke. OBJECTIVE: The study aims to compare the effects of 2 respiratory training programs, paired with individualized flexibility, strengthening, and cardiovascular exercise programs, on physiologic, activity, and societal participation outcomes in chronic stroke survivors. METHODS: This study will be a randomized controlled trial. Participants are 80 community-dwelling adults with chronic stroke. In conjunction with a 24-session (3 times/week for 8 weeks), American Heart Association-informed, whole-body exercise program, participants will be randomized to receive either respiratory strength training or respiratory relaxation training. Study intervention will be directed by a physical therapist and take place in a community fitness center. Outcome assessments will occur in a clinical research center. The primary outcome measure is maximal respiratory pressure. Secondary outcome measures include airway clearance, walking endurance, spatial-temporal gait characteristics, community walking, functional strength and fatigue, depression, and societal participation measures. Longer-term societal participation is a complex domain that may be influenced by other factors beyond physical function. Participants' health status will be monitored for 1 year following the intervention for falls, respiratory illness, and hospitalizations. Additional subanalyses will evaluate the effect of smoke exposure on short- and long-term outcomes. Outcome assessors are blinded to group assignments. Respiratory relaxation training is an active comparator, but no pure control group is included. RESULTS: This study was funded in March 2020 with enrollment commencing in November 2020. Completion of enrollment is projected for May 2025 with a study projected end date of April 2026. Published results are anticipated in Fall 2026. CONCLUSIONS: Results from this study will improve our understanding of the additive benefits of respiratory exercises on short- and long-term physiologic, functional, and societal gains for these individuals. These data will be instructive to meet a current unmet rehabilitative need to promote patient-centered care and contribute to decreasing morbidity and mortality in chronic stroke survivors. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05819333; https://clinicaltrials.gov/study/NCT05819333. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59749.
背景:慢性中风幸存者的持续性残疾通常归因于手臂或腿部无力;然而,呼吸肌无力也会阻碍中风后的康复,降低生活质量,并增加健康并发症的风险。中风后呼吸并发症很常见,使患者面临长期功能障碍和死亡的风险。此外,中风幸存者面临持续的心血管疾病,使他们有再次中风的风险。
目的:本研究旨在比较两种呼吸训练方案的效果,这两种方案与个体化的柔韧性、力量和心血管运动方案相结合,对慢性中风幸存者的生理、活动和社会参与结果的影响。
方法:这是一项随机对照试验。参与者为 80 名居住在社区的慢性中风成年人。在进行 24 节(每周 3 次,持续 8 周)美国心脏协会指导的全身运动计划的同时,参与者将被随机分配接受呼吸力量训练或呼吸放松训练。研究干预将由物理治疗师指导,并在社区健身中心进行。结果评估将在临床研究中心进行。主要结局测量指标是最大呼吸压力。次要结局指标包括气道清除、步行耐力、时空步态特征、社区行走、功能力量和疲劳、抑郁和社会参与指标。社会参与的长期结果是一个复杂的领域,可能受到身体功能以外的其他因素的影响。干预后 1 年内,参与者的健康状况将接受监测,以评估跌倒、呼吸道疾病和住院情况。额外的亚分析将评估吸烟暴露对短期和长期结果的影响。结果评估者对分组分配不知情。呼吸放松训练是一种积极的对照,但不包括纯对照组。
结果:该研究于 2020 年 3 月获得资金,2020 年 11 月开始入组。预计 2025 年 5 月完成入组,预计 2026 年 4 月完成研究。预计 2026 年秋季发表研究结果。
结论:这项研究的结果将提高我们对呼吸练习对这些个体的短期和长期生理、功能和社会获益的附加益处的理解。这些数据将有助于满足当前未满足的康复需求,促进以患者为中心的护理,并有助于降低慢性中风幸存者的发病率和死亡率。
试验注册:ClinicalTrials.gov:NCT05819333;https://clinicaltrials.gov/study/NCT05819333。
国际注册报告标识符(IRRID):DERR1-10.2196/59749。
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