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临床试验/NCT05081791
NCT05081791已完成不适用

Effects of Exercise Therapy on Functional Capacity, Muscle Strength and Patient-reported Outcomes in Patients with Muscle Dystrophies

Universitat Pompeu Fabra2 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2022年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
38
试验地点
2
主要终点
Timed Up and Go

研究概览

简要总结

Muscular Dystrophies (MD) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. Although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.Therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with MD on functional capacity, muscle strength, and health-related quality of life.

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

Post-training assessments will be conducted by a blinded assessor

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical or Genetically diagnosis of Muscular Dystrophy including Limb-Girdle type I and type II, Myotonic Dystrophy type I and type II and facioscapulohumeral dystrophy.
  • Age > 18 years old
  • Ability to walk independently for 10 or more metres

排除标准

  • Inability to understand or read Spanish/Catalan.
  • Patients engaging in a similar exercise-based program in the past 12 months
  • Patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program
  • Unstable respiratory, cardiovascular or metabolic disease

结局指标

主要结局

Timed Up and Go

时间窗: 1 week post-intervention

Time consumed by the patient to raise from a chair, walk 3 meters, turn 180º, walk 3 metres back and sit down on the chair

次要结局

  • Body Mass Index(1 week post-intervention)
  • Fatigue(1 week post-intervention)
  • Respiratory Muscle Strength(1 week post-intervention)
  • Short Physical Performance Battery(1 week post-intervention)
  • Upper Body Muscle Strength(1 week post-intervention)
  • Handgrip Strength(1 week post-intervention)
  • Health-Related Quality of Life(1 week post-intervention)
  • Body Weight(1 week post-intervention)
  • Percentage of fat-free mass(1 week post-intervention)
  • Physical Activity Levels(1 week post-intervention)
  • Lower Body Muscle Strength(1 week post-intervention)
  • Percentage of fat mass(1 week post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Raquel Sebio

Lecturer

Universitat Pompeu Fabra

研究点 (2)

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