Efficacy of Inspiratory Muscle Training in Patients With Amyotrophic Lateral Sclerosis: A Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Inspiratory muscle preassure: MIP
研究概览
简要总结
Amyotrophic Lateral Sclerosis (ALS) progressively damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in different muscles such as those used for movement or breathing. Breathing problems are one of the main causes of complications and reduced survival in people with ALS. This happens because the inspiratory muscles-those that help draw air into the lungs-gradually lose strength.
The study has the aim to explore the benefits of training inspiratory muscles in ALS patients in order to maintain the setrength of these muscles for as long as possible and look the impact on respiratory function.
详细描述
Amyotrophic Lateral Sclerosis (ALS) is a progressive disease that damages the nerve cells responsible for voluntary muscle movement. Over time, this leads to weakness in the muscles used for movement, speech, swallowing, and breathing. Breathing problems are one of the main causes of complications and reduced survival in people with ALS. This happens because the inspiratory muscles-those that help draw air into the lungs-gradually lose strength.
Maintaining the strength of these muscles for as long as possible is very important. Specific breathing exercises, known as inspiratory muscle training, can help strengthen these muscles by making them work against a gentle resistance when breathing in. This may help people with ALS maintain their breathing capacity longer, improve comfort and quality of life, and possibly extend survival time.
This study is a prospective, controlled, randomised, double-blind, masked, multicentre clinical trial that will include 44 people diagnosed with ALS who have lived with the disease for less than two years. It will take place in several hospitals and research centres.
Participants will be randomly divided into two groups:
Experimental group (22 participants): They will follow a 12-week inspiratory muscle training programme using a device that provides resistance when breathing in. This means the muscles have to work harder, much like resistance training for other parts of the body.
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
- Double (Participant, Outcomes Assessor)
盲法说明
To ensure participant blinding, both groups will use the same training device. In the control group, the device will be modified to simulate a resistance of 5 cmH₂O (less than 5% of Maximal Inspiratory Pressure), a level that does not produce any physiological training effect. The investigator supervising the intervention will not inform participants of their group assignment at any time.
To ensure blinding of outcome measurements, a separate investigator from the research team-who will not know participants' group allocation-will conduct all evaluations.
Finally, the statistician responsible for data analysis will also be blinded to group assignment. The study database will include only coded numerical identifiers, preventing identification of the intervention or control groups. Once statistical analyses are completed, results will be returned to the principal investigator, who will then unblind the data to identify which results correspond to each group.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with spinal ALS
- •men and women
- •diagnosis date less than two years ago, according to the "El Escorial" criteria (Appendix 2)
- •PIM above the lower limit of normal
- •Preserved lung function (FVC ≥ 80%, FEV1 ≥ 80%, FEV1/FVC ≥ 80%) and normal values in supine position
排除标准
- •Patients with signs of respiratory muscle weakness (MIP and MEP below the LLN and abnormal decubitus tests19-21)
- •Nocturnal hypoventilation
- •Inability to perform the measurement tests
- •Inability to understand and perform the exercises
- •Any contraindication to the use of IMT. Severe psychiatric illness.
研究组 & 干预措施
Intervention group
The experimental group will include 22 ALS participants. Based on baseline Maximal Inspiratory Pressure (MIP) and supine tests, an individualized inspiratory muscle resistance training program will be prescribed.
干预措施: Inspiratory muscle training (Device)
Control group
The control group will include 22 participants diagnosed with ALS. They will undergo the same baseline and follow-up assessments as the experimental group. Participants will receive their usual respiratory physiotherapy, which will be recorded throughout the study, and will perform the same inspiratory muscle training protocol but using a placebo device without the resistance valve, providing no inspiratory load. The follow-up schedule will be identical to the experimental group, with evaluations at 1, 2, 3, 6, and 12 months after the start of the intervention.
干预措施: Sham training (Device)
结局指标
主要结局
Inspiratory muscle preassure: MIP
时间窗: Baseline: Initial evaluation before the intervention. During intervention: Assessments at months 1, 2, and 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.
We follow the ATS/ERS recommended protocol. From a sitting position, the patient performs a full expiration to reach residual volume. Using a mouthpiece connected to a manometer, the patient is then instructed to perform a maximal inspiration and hold it for at least 3 seconds. This measurement will be repeated at least three times to ensure a minimal difference of ≤5% between attempts.
次要结局
- Maximal Expiratory Pressure: MEP(Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effect)
- Quality of life: ALSAQ-40(Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.)
- Forced espirometry(Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.)
- Functional assessment: ALSFRS-R(Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.)
- Nocturnal pulse oximetry(Baseline: Initial evaluation before the intervention. Post intervention: at the end of intervention, month 3. Follow-up: Assessments at months 6 and 12 from baseline to monitor long-term effects.)
研究者
Jordi Vilaró Casamitjana
Professor
University Ramon Llull