A Novel Combinatory Approach to Maximize Functional Recovery of Learning and Memory in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in objective new learning and memory (NLM).
研究概览
简要总结
The goal of this novel study is to compare the effect of a combined cognitive rehabilitation and exercise approach on new learning and memory (NLM) in persons with multiple sclerosis (pwMS) and mobility disability.
详细描述
The proposed research study will be the first to apply the Kessler Foundation modified Story Memory Technique (KF-mSMT®), the practice standard for cognitive rehabilitation, with one of two exercise programs. Alone, KF-mSMT® has been beneficial to NLM impairment, however, its effects are highly selective to list learning and as such, will not maximally restore NLM function. The combination of KF-mSMT® and exercise provides a robust approach towards maximal functional recovery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be blinded to the intent of the two exercise conditions. The outcomes assessor will also be blinded to the random assignment of enrolled participants.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be within the ages of 18 and 70 years of age
- •Speak English as their primary language
- •Confirmed MS diagnosis by a neurologist
- •Be relapse and steroid-free for at least 30 days
- •Mild-to-moderate self-reported mobility disability, based on the Patient Determined Disease Steps scale (PDDS)
- •Currently physically inactive, based on the Godin Leisure Time Exercise Questionnaire (GLTEQ)
- •Right handedness
排除标准
- •History of neurological disorders besides MS or history of uncontrolled psychiatric disorders (ex: major depression)
- •Have contraindications to exercise, based on the Physical Activity Readiness Questionnaire (PAR-Q)
- •Currently use medications that may impact cognition (ex: steroids, benzodiazepines)
- •Currently pregnant
- •Contraindication for MRI (metal or electronic devices in the body that are not considered MRI safe)
- •Severe cognitive impairment as measured by the Modified Telephone Interview of Cognitive Status (TICS-M)
研究组 & 干预措施
Cognitive Rehabilitation + Stretching and Toning
In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S/T. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
干预措施: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®) (Behavioral)
Cognitive Rehabilitation + Stretching and Toning
In the cognitive rehabilitation and stretching and toning (S/T) exercise condition, participants will complete 12 weeks of supervised S/T activities 3 days per week over the 12 week period. For seven weeks, participants will only complete S/T. During weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
干预措施: Stretching and Toning (S/T) (Behavioral)
Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)
In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
干预措施: The Kessler Foundation modified Story Memory Technique® (KF-mSMT®) (Behavioral)
Cognitive Rehabilitation + Aerobic Exercise with Virtual Reality (VR)
In the cognitive rehabilitation and aerobic exercise with VR condition, participants will complete a supervised, aerobic exercise training program (AET) integrated with virtual reality (Ideally Designed Exercise to Accelerate Learning/memory; IDEAL) three days per week over a 12 week period. For seven weeks, participants will only complete IDEAL. For weeks 8-12, participants will complete the Kessler Foundation modified story Memory Technique (KF-mSMT®), a memory retraining program on 2 of the 3 days per week.
干预措施: Aerobic Exercise Training (AET) plus Virtual Reality (IDEAL) (Behavioral)
结局指标
主要结局
Change in objective new learning and memory (NLM).
时间窗: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
The California Verbal Learning Test-Second Edition (CVLT-II) measures verbal learning and memory by having participants recall a list of words from 4 semantic categories. The word list is presented over 5 trials with a 20 minute delayed recall and recognition trial. Standardized T-scores range from 0-100, where higher scores indicated better performance.
Change in everyday memory
时间窗: Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention)
The Ecological Memory Simulations (EMS) is a multi-component test that measures memory as it relates to everyday life. Scores range from 0-205, where higher scores indicated better performance.
次要结局
- Change in hippocampal volume(Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention))
- Change in hippocampal function(Weeks 1 and 2 (pre-intervention) and Weeks 15 and 16 (post-intervention))
研究者
Carly Wender
Research Scientist
Kessler Foundation