跳至主要内容
临床试验/NCT04191772
NCT04191772已完成不适用

The Impact of Structured Exercise on Physical Fitness, Sedentary Time, Brain Volume, Cognitive, Health-related and Immunological Parameters in Multiple Sclerosis.

Hasselt University2 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2020年1月15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
156
试验地点
2
主要终点
Sitting time

研究概览

简要总结

The current study aims to investigate whether persons with Multiple Sclerosis (PwMS) compensate training time with more sedentary time and consequently blunt training effects. The second aim will be to investigate the effect of a structured training program on specific brain volumes and cognitive variables.

详细描述

Multiple Sclerosis is a progressive, autoimmune, neurodegenerative disorder of the central nervous system (CNS) that predominantly affects young to middle-aged adults. It is characterized by a chronic inflammatory process that causes demyelination, axonal damage and white matter lesions across the CNS. Furthermore, evidence also indicates grey matter (GM) atrophy which has been reported to be significantly correlated with both clinical and cognitive deterioration. Clinical manifestations include spasticity, tremor, paralysis, walking difficulties and cognitive abnormalities. Due to these primary disease symptoms, persons with MS (PwMS) appear to be susceptible to a sedentary lifestyle and inactivity, which consequently increases the risk of other important, health-related secondary deficits including respiratory, metabolic and cardiac dysfunction. These deficits further contribute to a decrease in cardiorespiratory fitness and quality of life (QoL), thereby causing a vicious circle of decreased exercise tolerance, greater disability and increased inactivity. Since pharmacological treatment has little impact on these secondary deficits, exercise therapy has become an important aspect of the treatment of MS.

Hence, exercise therapy interventions in MS have been studied extensively and have already been proven to significantly improve cardiorespiratory fitness, muscle strength, balance, fatigue, cognition, quality of life, respiratory function and brain volumes. Moreover, a dose-response relationship has been reported for functional variables such as strength and endurance capacity. As such, high intensity interval training (HIIT) probably is exerts superior effects compared to traditional low/moderate intensity continuous training (MICT). However and in contrast with other populations, effects of HIIT on important health-related variables such as body composition, blood pressure and blood lipid profiles are less evident. Possibly, PwMS do not reach the exercise intensities required to improve such factors due to cardiovascular autonomic dysfunction, leading to impaired carotid baroreflex control, attenuated elevations in blood pressure and disturbed increases in heart rate, and abnormal muscle energy metabolism. Moreover, higher intensities might hamper longer-term implementation in real life, as an inverse relation between exercise intensity and training adherence has already been reported.

Training periodization (alternating HIIT and MICT) offers a solution to overcome the barrier of adherence and concurrently augmenting training effects, but in contrast to other populations, the addition of a lower intensity training component does still not improve health-related variables. Therefore, other approaches are warranted. Recently, evidence is growing that sedentary time is an important health risk factor, independent of the (dis)practice of structured exercise. Hence, PwMS possibly compensate training effects with even more sedentary time, in addition to an already sedentary lifestyle as mentioned previously. As such, addressing sedentary time might be an interesting new approach to counteract the health-related deficits in PwMS. Therefore, the present study explores the impact of a structured exercise program on sedentary time and health-related variables.

Furthermore, a secondary aim of the current project is to investigate the effect of a periodized training program on brain volumes and cognitive function. Recent evidence of physical training effects on cognitive variables is contradictory. So for exercise intervention studies that studied the latter only used short-term and laboratory-based training programs and included exercise modalities (type, intensity, duration) that are difficult to compare. Interestingly, a recent short-term randomized controlled trial reported superior effects of HIIT on cognitive functions compared to MICT. Hence, the current study aims to investigate the impact of a long-term, home-based training program with HIIT-components on cognitive variables.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

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

  • Multiple Sclerosis according to the McDonald criteria (Relaps remitting)
  • Written informed consent
  • Medical safety screening

排除标准

  • Contra-indications to participate in moderate to high intensity exercise
  • Contra-indications to undergo magnetic resonance imaging (pacemaker/defibrillator or wires other than sternal wires, insulin pumps, metal foreign bodies, deep brain stimulator, cerebral aneurysm clips, cochlear implant, magnetic dental implant, drug infusion device)
  • Medication changes in the last month before the start of the intervention
  • Following or plan to follow a weight reduction program
  • Pregnancy
  • Participation in another study
  • Acute MS exacerbation < 3 months prior to the start of the study
  • EDSS score > 4
  • Consumption of more than 20 alcohol units/week
  • No daily internet access

结局指标

主要结局

Sitting time

时间窗: 3 months after the training program

Sedentary behaviour will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Stepping time

时间窗: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Number of steps per day

时间窗: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

Standing time

时间窗: 3 months after the training program

Physical activity will be measured with the ActivPAL3TM activity monitor (PAL Technologies Ltd, Glasgow, UK).

次要结局

  • Carbon dioxide output (VCO2)(Week 48 of the training protocol)
  • Respiratory gas exchange ratio (RER)(Week 48 of the training program)
  • Cardiorespiratory fitness (CRF)(Week 48 of the training program)
  • Lipidomic profile(Week 48 of the training program)
  • Height(Week 48 of the training program)
  • Blood pressure(Week 48 of the training program)
  • Resting heart rate(Week 48 of the training program)
  • Total calorie intake(3 months after the training program)
  • Macronutrient content(3 months after the training program)
  • Participation - Ghent Participation Scale (GPS)(Week 48 of the training program)
  • Fatigue - Modified Fatigue Impact scale (MFIS)(3 months after the training program)
  • Mobility - MS walking scale (MSWS-12)(Week 48 of the training program)
  • Oxygen uptake (VO2)(Week 48 of the training program)
  • Tidal volume (Vt)(Week 48 of the training program)
  • Breathing frequency (BF)(Week 48 of the training protocol)
  • serum cytokines(Week 48 of the training program)
  • Cognition - Spatial Recall test (SPART)(Week 48 of the training program)
  • Cognition - Symbol Digit Modalities Test (SDMT)(Week 48 of the training program)
  • Body weight(Week 48 of the training program)
  • DEXA (Dual Energy X-Ray)(Week 48 of the training program)
  • Coordination - timed tandem walk (TTW)(Week 48 of the training program)
  • Equivalents for oxygen uptake (VE/VO2)(Week 48 of the training protocol)
  • Equivalents for carbon dioxide production (VE/VCO2)(Week 48 of the training program)
  • Minute ventilation (VE)(Week 48 of the training protocol)
  • Brain volumes(Week 48 of the training program)
  • PBMC subset parameters(Week 48 of the training program)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bert Op't Eijnde

Principal Investigator

Hasselt University

研究点 (2)

Loading locations...

相似试验