Pilot Experimental Study on the Impact of a Respiratory Muscle Training Program in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Respiratory muscle strength
研究概览
简要总结
This is a quasi-experimental pre-post trial aimed at investigating the effects of respiratory muscle training (RMT) as trunk stabilization exercise in patients diagnosed with multiple sclerosis (MS)
详细描述
Multiple sclerosis (MS) is a chronic disease of the central nervous system that can affect various bodily functions, including the respiratory muscles. Weakness in these muscles can lead to a range of complications, including impacting trunk stability, which may result in difficulties maintaining a balanced and stable posture.
While the impact of MS on respiratory muscles and trunk stability is an area of interest in medical research, a definitive consensus on the efficacy of respiratory muscle training (RMT) to improve trunk stability in MS patients has not yet been reached. Several studies have yielded mixed results, leading to uncertainty regarding the effectiveness of this specific intervention.
The complex nature of multiple sclerosis necessitates a multidisciplinary approach to address its various clinical manifestations. In addition to pharmacological treatment, physical and occupational therapy play a crucial role in symptom management and improving patients' quality of life. Although respiratory muscle training may offer potential benefits, further research and well-designed clinical trials are needed to determine its effectiveness and role in the comprehensive management of trunk stability in MS patients.
- General objective: The aim of this study is to investigate the effects of respiratory muscle training (RMT) as a trunk stabilization exercise in patients diagnosed with multiple sclerosis (MS).
- Specific objectives: To analyze the effects of RMT on lung function measured through spirometric tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding will involve the evaluators, who will be unaware of which intervention group each subject belongs to
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Multiple Sclerosis based on McDonald criteria, with a disease duration of more than two years (relapsing or progressive) (McDonald et al., 2001).
- •All multiple sclerosis patients are included according to the Kurtzke Disability Status Scale (EDSS) ANEX II (Kurtzke 1983, Tollár 2020).*
- •Stable medical treatment for at least the six months prior to the intervention (Tollár, 2020).
- •Absence of cognitive impairment, with the ability to understand instructions and achieve a score equal to or greater than 24 on the Mini-Mental State Examination (Folstein, Folstein & McHugh, 1975, Tollár 2020).
排除标准
- •Diagnosis of another neurological disease or musculoskeletal alteration other than MS.
- •Diagnosis of any cardiovascular, respiratory, or metabolic disease, or other conditions that may interfere with this study.
- •Experienced exacerbation or hospitalization within the last 3 months prior to initiating the assessment protocol, nor during the therapeutic intervention process.
- •Received a cycle of steroids, intravenously or orally, 6 months prior to the start of the assessment protocol and within the study intervention period.
结局指标
主要结局
Respiratory muscle strength
时间窗: 2 months
Respiratory muscle strength is assessed using maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP). After measuring FVC and FEV1, participants will rest for 5 minutes before the next maneuver. MEP will be performed first, followed by MIP. Each maneuver will be repeated 6 times with 1 minute of rest in between. The highest MIP and MEP values, measured in cm3 of H2O, will be compared with population norms.
Balance
时间窗: 2 months
It will be measured with the BERG scale. This test is used to assess balance through functional abilities in standing position. It consists of 14 items to be rated from 0 to 4 (higher scores indicate better balance), with a total score of 56. This scale will only be administered to those MS patients who are able to walk.
Pulmonary function
时间窗: 2 months
Spirometric functional testing will be conducted according to SEPAR Regulation (2013). Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) will be measured using a pneumotachograph or open system spirometer. Participants' birth date and height will be recorded to compare with population averages. They will sit upright in a chair, wearing loose clothing, with a nasal clip to prevent leaks. Instructions will be given to exhale fully, then inhale deeply, hold briefly, and exhale forcefully. The researcher will correct any errors. Acceptable maneuvers must start quickly, have steady exhalation, and last at least 6 seconds. Three to eight maneuvers will be performed, and the best FVC and FEV1 values will be recorded.
Trunk control
时间窗: 2 months
Measured with the TIS Scale. The aim of this scale is to measure the static and dynamic stability of the trunk in sitting position without back support. It consists of 17 items and is scored according to the validated rubric. A higher score indicates better balance, with the highest possible score being 23 points. This scale is validated for patients with multiple sclerosis. This scale will only be administered to those MS patients who are able to walk.
Abdominal and diaphragmatic muscle structure
时间窗: 2 months
Ultrasound measurements of the abdominal wall and diaphragm will be conducted by an expert using the LOGIQ S7 Expert ultrasound system. To ensure accuracy and compliance with RUSI regulations, three measurements will be taken for each parameter, then averaged. 1. Diaphragm Ultrasound: Thickness and excursion during inspiration will be evaluated. Measurements will be taken in the right hemidiaphragm using a 10-12MHz linear probe, perpendicular to the intercostal space. Diaphragm thickness below 2mm is considered atrophy. Diaphragm excursion will be measured using a 2.5 to 3.5 MHz convex probe during tidal and forced inspirations. 2. Abdominal Musculature Ultrasound: Muscle layers and abdominal diastasis will be assessed. Abdominal diastasis will be measured with the participant lying supine, knees bent at 90º, and arms along the body. Muscle thickness will be measured at the navel level. Measurements will be taken at quiet and forced expiration.
Gait and transfer capacity
时间窗: 2 months
It will be measured with the Timed Up and Go test (TUG). The objective of this test is to assess activity limitations proposed by the ICF by examining the patient's ability to walk and perform transfers. The test involves rising from a chair, walking ten meters along an indoor flat corridor, turning 180º, and returning to sit back in the same chair, using the usual assistive device. The result of the test will be the total time taken from the command until the second sitting. This scale will only be administered to those MS patients who are able to walk.
次要结局
- Therapeutic adherence(2 months)