跳至主要内容
临床试验/NCT05385731
NCT05385731尚未招募不适用

MUSCLE - Nordic and Free Walking in People With Multiple Sclerosis: Clinical-functional, Motor Control, and Gait Analysis Findings: a Randomized Controlled Multicentre Clinical Trials

Leonardo A. Peyré-Tartaruga2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
2
主要终点
Locomotor Rehabilitation Index

研究概览

简要总结

The aim of the study is to analyze the effects of Nordic Walking and free walking in the clinical-functional, postural balance, motor control, muscular echographic quality, and gait analysis (pendulum gait mechanism), in people with Multiple Sclerosis.

详细描述

Objective

Analyze the effects of Nordic Walking and free walking in the clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, in people with Multiple sclerosis. Experimental Design: Randomized controlled multicenter clinical trial with translational study characteristics. Search Location: Exercise Research Laboratory at the School of Physical Education, Physiotherapy and Dance, Federal University of Rio Grande do Sul, Brazil, and University of Pavia, on Department of Public Health, Experimental Medicine and Forensic Sciences, Pavia, Italy. Participants: 60 patients from the Unified Health System (UHS) of both sexes, from 20 to 75 years old, diagnosed with multiple sclerosis, sedentary. Interventions: In this research, four groups of patients with multiple sclerosis will receive intervention during 4 months of different physical therapy programs (Nordic walking and free walking), who will receive telephone guidance for performing home-based exercises. The training programs will have a duration of 3 months and will be periodized so that the duration of the sessions is matched between them. The intensity of the interval training will be manipulated by the subjective effort scale (Borg) and by the heart rate, with predetermined series durations. All training programs will have a frequency of two sessions per week and a duration of 60 minutes. To evaluate the effects of the training, evaluations will be performed before and after the training period: 1) Basal (month 0): initial pre-training evaluation; 2) month 4: Evaluation 48h after the last training session. Outcomes: clinical-functional parameters, postural balance, muscular echography quality, pendulum gait mechanism, and biochemistry. Data Analysis: Data will be described by average values and standard deviation values. The comparisons between and within groups will be performed using a Generalized Estimating Equations (GEE) analysis, adopting a level of significance (α) of 0.05. Expected Results: The intervention groups of the Nordic walking are expected to be more effective in all outcomes analyzed, especially improving functional mobility when compared to the control group of unsupervised home exercises. In addition, it is expected that the results of the research will be expandable and the possibility of future developments in the scientific, technological, economic, social, and environmental fields and that they will be implemented in the Unified Health System (UHS).

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
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

double-blind (Investigator, Outcomes Assessor, Care Provider)

入排标准

年龄范围
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • volunteers aged over 20 years;
  • of both sexes;
  • with a clinical diagnosis of multiple sclerosis.

排除标准

  • severe heart diseases, uncontrolled hypertension, myocardial infarction within a period of less than one year, being a pacemaker;
  • stroke or other associated neurological diseases; insanity;
  • prostheses in the lower limbs;
  • without ambulation conditions.

结局指标

主要结局

Locomotor Rehabilitation Index

时间窗: Change from baseline at 12 weeks

The Locomotor Rehabilitation Index is a method of determining how close is the SSW compared to the Optimum Speed (Vopt).

Self-selected walking speed

时间窗: Change from baseline at 12 weeks

SSWS This outcome will be measure in test of treadmill walking

Test Timed Up and Go

时间窗: Change from baseline at 12 weeks

Test Timed Up and Go: This test evaluates the mobility functional in three meters of self-selected speed (TUGSS) or at forced speed (TUGFS) \[Time Frame: Change from baseline at 12 weeks\]

次要结局

  • Depressive symptoms(Change from baseline at 12 weeks)
  • Quality of life (QoL)(Change from baseline at 12 weeks)
  • Optimal Walking Speed (OPT)(Change from baseline at 12 weeks)
  • Cognitive function(Change from baseline at 12 weeks)
  • Expanded Disability Status Scale(Change from baseline at 12 weeks)

研究者

发起方
Leonardo A. Peyré-Tartaruga
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leonardo A. Peyré-Tartaruga

Associate Professor

Federal University of Rio Grande do Sul

研究点 (2)

Loading locations...

相似试验