跳至主要内容
临床试验/NCT06181500
NCT06181500已完成不适用

Home-Based Exercise in Primary Progressive Aphasia: a Pilot Study

Montreal Heart Institute4 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2023年4月5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
13
试验地点
4
主要终点
Evaluate the program completion rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

研究概览

简要总结

This pilot study aims to evaluate the feasibility of a novel home-based multicomponent exercise program in adults clinically diagnosed with Primary Progressive Aphasia

详细描述

Exercise is known to induce changes in brain neuroplasticity in the elderly and is thought to have a protective effect against cognitive decline in patients already suffering from neurodegenerative diseases. While the benefits of exercise in the context of mild cognitive impairment and Alzheimer's disease have been extensively studied, little information is available on the potential benefits of exercise for other atypical neurodegenerative diseases, such as primary progressive aphasia (PPA). A multimodal exercise intervention (combination of aerobic and resistance exercises) could potentially slow overall cognitive decline in PPA, which is characterized by a gradual and isolated dissolution of language function, by promoting neurogenesis and neuroplasticity. In healthy but inactive older adults, exercise increases grey and white matter volume in prefrontal and temporal cortical regions, which are specifically impaired in PPA and play an important role in executive functions, episodic memory and language skills. Exercise could thus modulate certain executive, memory and language difficulties generally observed in this clinical population. This pilot study aims to evaluate the feasibility of a novel home-based multicomponent exercise program in adults clinically diagnosed with any of the three main variants of PPA (semantic, non-fluent/agrammatic or logopenic). The feasibility outcomes will be based on: 1) total recruitment and recruitment rate, 2) program completion rate, 3) compliance and 4) participants' ability to train at home with or without a caregivers' presence. A minimum of 12 participants will be recruited through McGill University's Douglas Research Institute and will complete a 6-month home-based multimodal intervention program. They will train two to three times a week for 45 minutes and be supervised via videoconference by a kinesiologist from the EPIC Center at the Montreal Heart Institute. If desired, participants will be accompanied by a partner, close friend, or relative to facilitate communication, especially if they have difficulty understanding instructions or expressing themselves. To assess changes in cognition, physical and psychological functions, participants will complete neuropsychological and functional assessments in-person at baseline. These assessments will also be completed at three and six months post-intervention. The knowledge gained from this pilot project will be used to assess the feasibility of a full randomized control trial aimed at assessing the effects of multimodal exercise intervention in PPA patients. Ultimately, an increased understanding of the potential beneficial effects of physical exercise in PPA will allow for more tailored rehabilitative approaches in this clinical population.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • A clinical diagnosis of Primary Progressive Aphasia
  • Fluent in French or English
  • Able to read, understand and sign the information and consent form
  • Have access to the internet
  • Have access to a tablet (i.e. iPad or Android) or a computer

排除标准

  • Any absolute and relative contraindication to exercise testing and/or physical training (e.g., any severe musculoskeletal disease impairing their mobility)
  • Any severe respiratory disease (e.g., asthma, COPD, COVID-19)
  • Any severe exercise intolerance

结局指标

主要结局

Evaluate the program completion rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

时间窗: 6 months post-intervention

Program completion rate (number of participants that completed their in-person evaluations as well as the home-based interventions after 6 months compared to the participants enrolled)

Evaluate the compliance rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

时间窗: 6 months post-intervention

Compliance (total number of in-person evaluations and home-based training sessions attended compared to the maximum possible)

Evaluate the total recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

时间窗: 6 months post-intervention

Total recruitment (number of participants screened compared to final enrollments)

Evaluate the satisfaction of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

时间窗: 6 months post-intervention

Satisfaction (feedback given by the participants and their caregivers will be considered using a satisfaction questionnaire and qualitative feedback). Ability to train at home with or without their caregivers' presence will also be taken into account.

Evaluate the recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia

时间窗: 6 months post-intervention

Recruitment rate (number of participants that can be enrolled per month)

次要结局

  • Document changes in nonverbal fluency(Baseline and 6 months post-intervention)
  • Document changes in writing ability(Baseline and 6 months post-intervention)
  • Document changes in reading comprehension(Baseline and 6 months post-intervention)
  • Document change in upper limb muscle strength(Baseline and 6 months post-intervention)
  • Document change in lower limb muscle strength(Baseline and 6 months post-intervention)
  • Document changes in walking speed(Baseline and 6 months post-intervention)
  • Document changes in general cognitive functioning(Baseline and 6 months post-intervention)
  • Document changes in verbal working memory(Baseline and 6 months post-intervention)
  • Document changes in oral expression(Baseline and 6 months post-intervention)
  • Document changes in executive functions and processing speed(Baseline and 6 months post-intervention)
  • Document changes in cardiorespiratory fitness(Baseline and 6 months post-intervention)
  • Document changes in auditory long-term memory(Baseline and 6 months post-intervention)
  • Document changes in visual working memory(Baseline and 6 months post-intervention)
  • Document changes in verbal fluency(Baseline and 6 months post-intervention)
  • Document changes in lexical retrieval(Baseline and 6 months post-intervention)
  • Document change in balance performance(Baseline and 6 months post-intervention)
  • Document changes functional mobility(Baseline and 6 months post-intervention)
  • Document changes in visual long-term memory(Baseline and 6 months post-intervention)
  • Document changes in endurance(Baseline and 6 months post-intervention)
  • Document changes in auditory comprehension(Baseline and 6 months post-intervention)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Louis Bherer

Director of the EPIC Center and Scientist, Montreal Heart Institute

Montreal Heart Institute

研究点 (4)

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