跳至主要内容
临床试验/NCT06233370
NCT06233370进行中(未招募)1 期

Acute Effects of Walking Exercise on Brain Functioning in Multiple Sclerosis

Kessler Foundation1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年3月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
24
试验地点
1
主要终点
Brain Function

研究概览

简要总结

The project will involve a within-subjects, repeated-measures research design. Participants will initially be screened for relevant inclusion/exclusion criteria for maximizing safety of participating in an exercise study. If a participant meets those inclusion/exclusion criteria, they will visit Kessler Foundation three times. The first visit will involve a baseline session where participants will complete several cognitive tests. This will be followed by a training session, where participants will be provided with a FitBit, and will be trained by research staff to walk at a rate of 100 steps per minute. Once participants demonstrate proficiency at walking at this rate using the FitBit, participants will complete several questionnaires, followed by a maximal, graded exercise test to determine cardiorespiratory fitness. One week later, participants will return to Kessler Foundation to complete 1 of 2 experimental sessions that will be delivered in a random order that further will be counterbalanced across participants (to minimize the potential effects of session order on brain function and blood flow, respectively). Both experimental sessions will follow the same structure. First, participants will undertake a 30-minute MRI scan at Kessler Foundation to measure brain function and brain blood flow. Immediately following the MRI scan, participants will engage in either 20 minutes of treadmill walking exercise or 20 minutes of overground walking exercise at a rate of 100 steps per minute. Immediately following the 20-minute exercise bouts, participants will undertake another MRI scan for measuring brain function and brain blood flow. Participants will return to Kessler Foundation a third time to complete the opposite experimental session that was not completed during the second visit (i.e., overground walking exercise if treadmill walking exercise was completed during the second visit). In total, each participant will undergo four MRI scans over the course of the study (i.e., pre-treadmill, post-treadmill, pre-overground, post-overground). .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Clinically-definite MS diagnosis
  • •Relapse-free for at least 30 days
  • •Low risk for contraindications for exercise testing
  • •Low risk for contraindications for MRI
  • •Historically physically inactive prior to MS diagnosis
  • •Historically highly physically active prior to MS diagnosis

排除标准

  • •Diagnosis of uncontrolled major depressive disorder, schizophrenia, bipolar disorder I or II, or substance use disorders
  • •Taking medications that can affect cognition (e.g., antipsychotics, benzodiazepines)
  • •Historically moderately physically active prior to MS diagnosis

研究组 & 干预措施

Over ground walking exercise

Experimental

Participants will walk around a square hallway at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps.

干预措施: Moderate intensity walking exercise (Behavioral)

Treadmill walking exercise

Experimental

Participants will walk on a motor-driven treadmill at a step rate of ~100 steps per minute for 20 minutes while wearing a Fitbit around the waist for measuring steps.

干预措施: Moderate intensity walking exercise (Behavioral)

结局指标

主要结局

Brain Function

时间窗: Weeks 2 and 3

MRI-measured resting-state functional connectivity of the thalamus with other areas of the brain

Brain Blood Flow

时间窗: Weeks 2 and 3

MRI-measured cerebral blood flow perfusion in the left and right hemispheres

次要结局

未报告次要终点

研究者

发起方
Kessler Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Brian Sandroff

Senior Research Scientist

Kessler Foundation

研究点 (1)

Loading locations...

相似试验