Hammel Neurorehabilitation Centre and University Research Clinic, RM, University of Aarhus, Voldbyvej 15, 8450, Hammel, Denmark.
Trials. 2021 Aug 28;22(1):575. doi: 10.1186/s13063-021-05551-8.
Stroke results in varying physical, cognitive, emotional and/or social disabilities in the short and long term alike. Motor impairments are important, persistent consequences of stroke and include, among others, decreased respiratory muscle function, decreased ability to expand the thorax and postural dysfunction. These deficits affect the patient's ability to perform daily activities, produce fatigue and reduce endurance and quality of life. Inspiratory muscle training (IMT) aims to improve the strength and endurance of the diaphragm and the external intercostal muscles. The objectives of this study are to investigate the effect of 3 weeks of IMT on (i) maximal inspiratory pressure (MIP) in adults having suffered a stroke, as well as (ii) functional activities and expiratory measurements.
METHODS/DESIGN: This is a randomised controlled trial (RCT) comparing IMT with conventional neurorehabilitation (usual practice). The trial will include 80 patients with reduced MIP hospitalised at a specialised neurorehabilitation hospital in Denmark. The intervention group will receive IMT sessions, exercising at 30% of MIP. Patients in the intervention group will perform two daily sessions (one session of IMT with Threshold IMT consisting of two times 15 inspirations at normal breathing rhythm (5-10 min)), 7 days a week for 3 weeks. Training can be with or without physiotherapist supervision.
MIP assessed by the Power Breath, Functional Independence Measurement, The 6-min walk test, the Fatigue Severity Scale and average voice volume. Expiratory function will be assessed using spirometry. All assessments will be conducted at baseline and 3 weeks (at termination of the intervention) and 3 months after the intervention has concluded.
IMT is a promising and partly self-managed tool for rehabilitation to improve respiratory function. The introduction of IMT in combination with traditional physical therapy may enhance faster recovery after stroke and may at the same time demand little personnel resources to increase training intensity. This trial will provide further evidence of IMT to clinicians, patients and health managers. Hereby, this study accepts the call for further research.
ClinicalTrials.gov NCT04686019 . Registered on 28 December 2020.
中风会导致短期和长期的身体、认知、情感和/或社交功能障碍。运动障碍是中风的重要且持久的后果之一，包括呼吸肌功能下降、胸廓扩张能力下降和姿势功能障碍等。这些缺陷会影响患者进行日常活动的能力，产生疲劳，并降低耐力和生活质量。吸气肌训练（IMT）旨在提高膈肌和肋间外肌的强度和耐力。本研究的目的是探讨 3 周 IMT 对（i）中风后成年人的最大吸气压力（MIP）以及（ii）功能活动和呼气测量的影响。
方法/设计：这是一项随机对照试验（RCT），比较 IMT 与常规神经康复（常规实践）。该试验将包括 80 名在丹麦一家专门的神经康复医院住院的 MIP 降低的中风患者。干预组将接受 IMT 治疗，以 30%的 MIP 进行运动。干预组的患者将每天进行两次治疗（一次 IMT 治疗，包括两次在正常呼吸节奏下进行 15 次吸气的阈下 IMT 治疗[5-10 分钟]），每周 7 天，共 3 周。训练可以有或没有物理治疗师的监督。
使用 Power Breath 评估 MIP、功能独立性测量、6 分钟步行测试、疲劳严重程度量表和平均语音音量。使用肺活量计评估呼气功能。所有评估将在基线和 3 周（干预结束时）以及干预结束后 3 个月进行。
IMT 是一种有前途的、部分自我管理的康复工具，可改善呼吸功能。在传统物理治疗的基础上引入 IMT 可能会加速中风后的恢复，同时需要较少的人员资源来增加训练强度。本试验将为临床医生、患者和卫生管理人员提供更多关于 IMT 的证据。因此，本研究接受了进一步研究的呼吁。
ClinicalTrials.gov NCT04686019。于 2020 年 12 月 28 日注册。
