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临床试验/NCT05671588
NCT05671588招募中不适用

Cardiovascular Fitness and the Influence of a Controlled Combined Exercise Program on Fatigue and Depression of Newly Diagnosed Patients With Multiple Sclerosis

University Hospital Ostrava2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
70
试验地点
2
主要终点
Power to weight ratio (W.kg-1)

研究概览

简要总结

This study is focused on patients with multiple sclerosis (MS), their cardiovascular fitness, and the effect of combined controlled training on the perception of fatigue, the development of depression, and quality of life in the first year after diagnosis.

详细描述

The main goal is to find out if fatigue, depression, and quality of life depend on the type of training as well as controlled management of newly diagnosed patients. Fatigue is one of the frequent disabling symptoms and the most difficult to influence pharmacologically. It could lead to inactivity and the progression of deconditioning. We know from systematic reviews that aerobic activity leads to improvement in fatigue, however, there are also opinions about exercise intolerance due to disruption of cardiac autonomy control. The investigators will try to determine whether early rehabilitation intervention leads to support and motivation of patients with an incurable chronic neurodegenerative disease to improve the patient condition and contentment. The researchers will focus on effective training by comparing the study group with a control group of patients undergoing conventional rehabilitation versus a protocol-defined controlled combined (aerobic-resistant) exercise program - based on the results of spiroergometry. Both groups will be treated at ambulatory sections by protocol-defined rehabilitation for a 1-hour duration, twice a week for one month, and once a week for the next month (12 therapies in total). The control group will be educated in exercises according to kinesiological analysis to do regularly at home. Finally, the researchers will see if early intervention leads to a change in the active approach of probands.

研究设计

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

盲法说明

All participants of the study will undergo a clinical examination including a questionnaire survey and spiroergometry - examiners will not have access to intervention documents before and after the intervention (period of 6 months), as well as examiners will not perform the therapy.

入排标准

年龄范围
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20 - 45 years
  • Newly diagnosed patients with multiple sclerosis
  • Relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS)
  • Signed informed consent

排除标准

  • Progressive forms of MS (PRMS or SPMS), Malignant MS
  • Non-cooperation, disagreement with the study
  • Contraindication to spiroergometry

结局指标

主要结局

Power to weight ratio (W.kg-1)

时间窗: 6 months

Change after six months follow up in conventional, experimental and control group

Maximal aerobic capacity (VO2max.kg-1)

时间窗: 6 months

Change after six months follow up in conventional, experimental and control group

次要结局

  • Symptom-Checklist-90-Standard (SCL-90-S)(6 months)
  • Modified Fatigue Impact Scale (MFIS)(6 months)
  • 36-Item Short Form Survey (SF-36)(6 months)
  • Heart rate variability (ms)(6 months)
  • Beck Depression Inventory Score II (BDI II)(6 months)
  • Maximal heart rate (bpm)(6 months)
  • Body composition analysis %)(6 months)

研究者

发起方
University Hospital Ostrava
申办方类型
Other
责任方
Sponsor

研究点 (2)

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