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临床试验/NCT04889248
NCT04889248已完成不适用

Inspiratory Muscle Training in Respiratory Capacity, Heart Rate Variability, Life Quality and Emotional State in Patients With Amyotrophic Lateral Sclerosis.

Universidad Francisco de Vitoria2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年5月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
2
主要终点
PImax

研究概览

简要总结

Abstract:

Context/background: people affected by Amyotrophic Lateral Sclerosis (ALS) see their own life totally disturbed after the diagnosis. This disease also courses, apart from the functional and depressing worsening, with internal damage manifested by a cardio respiratory deterioration. There are not many clinical studies publications about this disease given that is considered a weird illness with short prognosis.

Objectives: to examine the effects of the inspiratory muscle training (IMT) on respiratory muscle strength, heart rate variability (HRV), quality of life and mood in patients with ALS.

Methods: 20 volunteer patients, male and female, with ALS, bulbar or spinal will take part of the cuasi-experimental study and they will be divided into two groups: an experimental group (n = 10) and a control group (n = 10). The Maximum Inspiratory Pressure (PIM), the HRV, the quality of life and mood will be measured. The participants of experimental group will conduct 30 inspirations per day, 15 in the morning and 15 in the evening, 5 days per week, through 8 weeks. The resistance of the training in the experimental group will be increase acording to the PIM measured at the first visit. During the first week, the resistance will be at 30% of PImax, weeks 2 and 3 at 40%, weeks 4 and 5 at 50% and the last 3 weeks at 60%. After 8 weeks, all participants will fill up again all scales and post training measurements will be taken.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Subjects with ALS

排除标准

  • PImax more than 30mmH2O
  • Score higher than 2 in GDS Reisberg scale
  • Using already respiratory devices during the day (except night CPAPs support) more than 14h/day.
  • Unstable medical disease for the last 3 years.
  • Use of IMT contraindicated for medical reasons.

结局指标

主要结局

PImax

时间窗: 8 weeks

Maximum Inspiratory Pressure

次要结局

  • HR(8 weeks)
  • ALSFRS-R(8 weeks)
  • HRV(8 weeks)
  • ALSAQ-40(8 weeks)
  • Beck scale(8 weeks)

研究者

发起方
Universidad Francisco de Vitoria
申办方类型
Other
责任方
Sponsor

研究点 (2)

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