Programa de Pós-Graduação em Distúrbios da Comunicação Humana, Universidade Federal de Santa Maria (UFSM), Avenida Roraima, 1000, Santa Maria, 97105-900, Brazil.
Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Rio Grande do Sul, 90010-150, Brazil.
Trials. 2023 Aug 15;24(1):532. doi: 10.1186/s13063-023-07558-9.
Evidence has shown that patients with chronic obstructive pulmonary disease present significant deficits in the control of postural balance when compared to healthy subjects. In view of this, it is pertinent to investigate the effects of different therapeutic strategies used alone or in association with pulmonary rehabilitation with the potential to improve postural balance and other outcomes with clinical significance in patients with chronic obstructive pulmonary disease. This study will investigate the effects of an 8-week (short-term) multimodal exercise program [inspiratory muscle training (IMT) plus neuromuscular electrical stimulation (NMES)] on postural balance in patients with chronic obstructive pulmonary disease enrolled in a pulmonary rehabilitation program compared to individualized addition of IMT or NMES to pulmonary rehabilitation or standard pulmonary rehabilitation.
This is a randomized, single-blind, 4-parallel-group trial. Forty patients with chronic obstructive pulmonary disease will be included prospectively to this study during a pulmonary rehabilitation program. Patients will be randomly assigned to one of four groups: multimodal exercise program (IMT + NMES + pulmonary rehabilitation group) or (IMT + pulmonary rehabilitation group) or (NMES + pulmonary rehabilitation group) or standard pulmonary rehabilitation group. Patients will receive two sessions per week for 8 weeks. The primary outcome will be static postural balance and secondary outcomes will include as follows: static and dynamic postural balance, fear of falling, muscle strength and endurance (peripheral and respiratory), functional capacity, health-related quality of life, muscle architecture (quadriceps femoris and diaphragm), and laboratory biomarkers.
This randomized clinical trial will investigate the effects of adding of short-term multimodal exercise program, in addition to pulmonary rehabilitation program, in postural balance in patients with chronic obstructive pulmonary disease enrolled in a pulmonary rehabilitation. Furthermore, this randomized control trial will enable important directions regarding the effectiveness of short-term intervention as part of the need to expand the focus of pulmonary rehabilitation to include balance management in chronic obstructive pulmonary disease patients which will be generated.
ClinicalTrials.gov NCT04387318. Registered on May 13, 2020.
有证据表明，与健康受试者相比，慢性阻塞性肺疾病患者在姿势平衡控制方面存在明显缺陷。有鉴于此，有必要研究单独或联合肺康复使用的不同治疗策略对慢性阻塞性肺疾病患者的姿势平衡和其他具有临床意义的结果的影响。本研究将调查为期 8 周（短期）的多模式运动方案[吸气肌训练（IMT）加神经肌肉电刺激（NMES）]对参加肺康复计划的慢性阻塞性肺疾病患者的姿势平衡的影响，与将 IMT 或 NMES 个体化添加到肺康复或标准肺康复中相比。
这是一项随机、单盲、4 平行组试验。在肺康复计划期间，将前瞻性地纳入 40 名慢性阻塞性肺疾病患者进行这项研究。患者将被随机分配到以下四组之一：多模式运动方案（IMT+NMES+肺康复组）或（IMT+肺康复组）或（NMES+肺康复组）或标准肺康复组。患者将每周接受两次治疗，持续 8 周。主要结局将是静态姿势平衡，次要结局将包括以下内容：静态和动态姿势平衡、跌倒恐惧、肌肉力量和耐力（周围和呼吸）、功能能力、健康相关生活质量、肌肉结构（股四头肌和膈肌）和实验室生物标志物。
这项随机临床试验将研究在参加肺康复的慢性阻塞性肺疾病患者中，除肺康复计划外，短期多模式运动方案的添加对姿势平衡的影响。此外，这项随机对照试验将为短期干预的有效性提供重要指导方向，作为需要扩大肺康复重点以包括慢性阻塞性肺疾病患者平衡管理的一部分，这将产生影响。
ClinicalTrials.gov NCT04387318。注册于 2020 年 5 月 13 日。
