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临床试验/NCT04562376
NCT04562376已完成不适用

High-intensity Resistance Training in People With Multiple Sclerosis Experiencing Fatigue - Effects on Functioning, Wellbeing and Inflammatory Biological Markers

Karolinska Institutet2 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2020年8月20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
73
试验地点
2
主要终点
Fatigue Scale for Motor and Cognitive Functions

研究概览

简要总结

Fatigue is one of the most frequently reported and disabling impairments in multiple sclerosis (MS) and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL).MS fatigue is thought to be related to the disease itself, where increased levels of inflammatory biological markers (cytokines) are contributing. Resistance training may have an anti-inflammatory effect where a higher intensity is thought to have a more profound effect. Moderate-intensity resistance training is well tolerated in people with MS (PwMS) and can reduce self-reported fatigue. There is, however, a lack of high-quality studies including only fatigued PwMS when evaluating exercise regimes. Furthermore, the optimal dose (i.e. the combination of duration, frequency and intensity) is not known. Our hypothesis is that high-intensity resistance training will have positive effects in fatigued PwMS on functioning (fatigue, mood, activities and participation) and wellbeing/HRQL; and a positive immunomodulatory effect measured by inflammatory biological markers in blood. Further, that high-intensity resistance training twice a week will be superior to once a week

详细描述

Multiple sclerosis (MS) is chronic inflammatory neurodegenerative disease. About two-thirds of persons with MS (PwMS) report MS-related fatigue. It is a most disabling impairment and is associated with activity limitations, participation restrictions and reduced health-related quality of life (HRQL). MS fatigue may be related directly to the disease, e.g. inflammation. Resistance training can have direct effects on the MS disease by modulating cytokine levels, where a higher intensity is thought to have a more profound effect. Thus, there are reasons to hypothesise that high-intensity resistance training might reduce fatigue in PwMS. There are, however, no randomized controlled trials (RCTs) on resistance training in PwMS with fatigue. Although the recommendation of resistance training for adults with chronic diseases is twice a week, most primary health-care providers in Sweden only offer supervised training once a week for a limited period, e.g. 8-12 weeks. Thus, our aims are to evaluate the effects of 12 weeks high-intensity resistance training on functioning (fatigue, mood, activities and participation), wellbeing/HRQL and on inflammatory biological markers (e.g. cytokines) in blood. In this two-armed single-blinded RCT, 90 PwMS with fatigue will be recruited and randomly assigned to receive high-intensity resistance training under the supervision from a physiotherapist twice a week (group A) or once a week (group B). Primary outcome is fatigue measured with a patient reported outcome, i.e. the Fatigue Scale for Motor and Cognitive Functions (FSMC), and a change-score of ten points is considered clinically meaningful. Secondary outcomes include measures of mood, participation, self-perceived impact of MS, wellbeing/HRQL and inflammatory biological markers in blood. Data will be collected at baseline and within a week after the last training session of the 12-week intervention. All participants will after the end of intervention be offered a prescription of physical activity (FaR), and have the opportunity for follow-up telephone calls at 3-, 6- and 12 months after the end of the intervention. Assessment of fatigue will also be performed at these follow-up telephone sessions. Fatigue assessments from a natural history cohort (Combat study) will be available for comparisons of natural fluctuations of fatigue.

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

A person with no further involvement in the study will manage the randomization. A research assistant will assign participants with an identification number which will be used during baseline and follow-up assessments to ensure blinding of the assessors. Thus, outcome assessors are blinded for group allocation. Data entry will be executed by a person blinded for group allocation.

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

  • Adults older than 18 years with the diagnosis MS according to the revised McDonald Criteria, having fatigue (i.e. ≥ 53 FSMC sum score), able to understand and communicate in Swedish, and not practicing high-intensity training within 6 months prior to the trial.

排除标准

  • Other conditions or diagnoses judged to potentially interfere with the trial.

结局指标

主要结局

Fatigue Scale for Motor and Cognitive Functions

时间窗: Directly after the intervention (ie change from assessments at baseline to follow-up after the 12 week intervention)

Fatigue measured with the FSMC, minimum value 20, maximum value 100, higher scores mean a worse outcome

次要结局

  • Multiple Sclerosis Impact Scale-29(Directly after the intervention)
  • Hospital Anxiety and Depression Scale(Directly after the intervention)
  • Occupational Gaps Questionnaire(Directly after the intervention)
  • Euroqool five dimension five level(Directly after the intervention)
  • Euroqool visual analogue scale(Directly after the intervention)
  • Fatigue Severity Scale(Directly after intervention)
  • Multiplex proteomic immunoassay and enzyme-linked immunosorbent assay(Directly after the intervention)

研究者

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

Marie Kierkegaard

Associate Professor (Docent)

Karolinska Institutet

研究点 (2)

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