Clinical trial NCT06181500: Home-Based Exercise in Primary Progressive Aphasia (HEPPA)
Official title: Home-Based Exercise in Primary Progressive Aphasia: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Neurodegenerative Diseases
Logopenic Progressive Aphasia
Semantic Dementia
Non-fluent Aphasia
Keywords: Primary Progressive Aphasia
Home-Based Exercise Intervention
Pilot Study
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Evaluate the total recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia
timeFrame: 6 months post-intervention
measure: Evaluate the recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia
timeFrame: 6 months post-intervention
measure: Evaluate the program completion rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia
timeFrame: 6 months post-intervention
measure: Evaluate the compliance rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia
timeFrame: 6 months post-intervention
measure: Evaluate the satisfaction of a 6-month exercise intervention in individuals with Primary Progressive Aphasia
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Document changes in general cognitive functioning
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in auditory long-term memory
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in visual long-term memory
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in verbal working memory
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in visual working memory
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in nonverbal fluency
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in verbal fluency
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in reading comprehension
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in writing ability
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in auditory comprehension
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in oral expression
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in lexical retrieval
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in executive functions and processing speed
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in endurance
timeFrame: Baseline and 6 months post-intervention
measure: Document change in balance performance
timeFrame: Baseline and 6 months post-intervention
measure: Document change in upper limb muscle strength
timeFrame: Baseline and 6 months post-intervention
measure: Document change in lower limb muscle strength
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in walking speed
timeFrame: Baseline and 6 months post-intervention
measure: Document changes functional mobility
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in cardiorespiratory fitness
timeFrame: Baseline and 6 months post-intervention
Other outcomes:
measure: Document changes in quality-of-life
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in depressive symptomatology
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in anxiety
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in perceived stress
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in sleep quality
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in risk of sleep apnea
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in self-reported physical activity
timeFrame: Baseline and 6 months post-intervention
measure: Document changes in neuropsychiatric symptoms
timeFrame: Baseline and 6 months post-intervention
measure: Document Cognitive Reserve
timeFrame: Baseline
measure: Document perceived social support
timeFrame: Baseline
Locations:
city: Montréal
country: Canada
facility: Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Research Centre for Studies in Aging (MCSA)
state: Quebec
Study officials:
affiliation: Centre ÉPIC, Institut de cardiologie de Montréal
name: Louis Bherer
role: PRINCIPAL_INVESTIGATOR
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