Home-Based Exercise in Primary Progressive Aphasia (HEPPA)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Home-Based Exercise in Primary Progressive Aphasia: A Pilot Study

Conditions
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Primary Progressive Aphasia, Neurodegenerative Diseases, Logopenic Progressive Aphasia, Semantic Dementia, Non-fluent Aphasia

Intervention / Treatment
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* Other: Home-based multicomponent exercise intervention program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Home-based multicomponent exercise intervention program<br> | Other: Home-based multicomponent exercise intervention program<br>* A novel home-based multicomponent exercise intervention program was designed using a multimodal training circuit. This 24-week circuit program was created to improve functional (resistance) and aerobic health. Participants will be asked to train two to three times a week for 45 minutes. They will be supervised via videoconference by a trained kinesiologist from the EPIC Center at the Montreal Heart Institute. If desired, participants can complete their exercises with a partner, friend, or relative to facilitate communication. Participants will be asked to document the perceived intensity of their exercises in a booklet after each workout. The perceived intensity of their exercises will be measured by a validated effort perception scale graduated from 0 to 10 (Borg scale; Williams, 2017). Progressions will increase every five weeks and will be subject to modification if not properly tolerated or if found to be below a 3 on the Borg rate of perceived exertion scale (moderate intensity).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the total recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia | Total recruitment (number of participants screened compared to final enrollments) | 6 months post-intervention | 
| Evaluate the recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia | Recruitment rate (number of participants that can be enrolled per month) | 6 months post-intervention | 
| Evaluate the program completion rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia | 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) | 6 months post-intervention | 
| Evaluate the compliance rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia | Compliance (total number of in-person evaluations and home-based training sessions attended compared to the maximum possible) | 6 months post-intervention | 
| Evaluate the satisfaction of a 6-month exercise intervention in individuals with Primary Progressive Aphasia | 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. | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Document changes in general cognitive functioning | Participants will complete the Montreal Cognitive Assessment (scores range from 0-28, with a higher score indicating better cognitive functioning). | Baseline and 6 months post-intervention | 
| Document changes in auditory long-term memory | Participants will complete the Rey auditory verbal learning test (scores range from 0-15, with a higher score indicating a better auditory long-term memory). | Baseline and 6 months post-intervention | 
| Document changes in visual long-term memory | Participants will complete the Rey-Osterrieth complex figure test (scores range from 0-36, with a higher score indicating a better visual long-term memory). | Baseline and 6 months post-intervention | 
| Document changes in verbal working memory | Participants will complete the forward and backward digit span subtasks of the Wechsler Adult Intelligence Scale-IV (scores range from 0-32, with a higher number indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in visual working memory | Participants will complete the spatial span subtask of the Wechsler Memory Scale-III (scores range from 0-32, with a higher number indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in nonverbal fluency | Participants will complete the Ruff figure fluency test (scores are based on the total number of figures drawn, with a higher number indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in verbal fluency | Participants will complete phonemic and semantic fluency tasks (scores are based on the total number of words given, with a higher number indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in reading comprehension | Participants will complete the Chapman-Cook (scores range from 0-30, with a higher score indicating better reading comprehension). | Baseline and 6 months post-intervention | 
| Document changes in writing ability | Participants will complete the Bernard Croisile dictation task (scores range from 0-18, with a higher score indicating better writing ability). | Baseline and 6 months post-intervention | 
| Document changes in auditory comprehension | Participants will complete the Boston Diagnostic Aphasia Examination (BDAE) subtasks: word, body part, commands, story comprehension, and the word-picture matching (scores range from 0-36, with higher scores indicating better auditory comprehension). | Baseline and 6 months post-intervention | 
| Document changes in oral expression | Participants will complete the word/sentence repetition subtasks from the Boston Diagnostic Aphasia Examination (BDAE) (scores range from 0-14, with higher scores indicating better oral expression). | Baseline and 6 months post-intervention | 
| Document changes in lexical retrieval | Participants will complete the Boston Naming Test (scores range from 0-30, with a higher score indicating better lexical retrieval). | Baseline and 6 months post-intervention | 
| Document changes in executive functions and processing speed | Participants will complete validated neuropsychological tests and iPad tests (scores are measured in milliseconds, with lower reaction times indicating faster processing speeds). | Baseline and 6 months post-intervention | 
| Document changes in endurance | Endurance will be assessed with a 6 min walking test (scores are measured in the number of meters walked, with a higher number of meters indicating a better score). | Baseline and 6 months post-intervention | 
| Document change in balance performance | Balance performance will be assessed with a timed one-leg standing test (scores are measured in seconds, with a higher time indicating a better score). | Baseline and 6 months post-intervention | 
| Document change in upper limb muscle strength | Upper limb muscle strength will be assessed with a grip strength test (scores are measured with the maximum force/tension generated by one's forearm muscles, with a higher kilogram indicating a better score). | Baseline and 6 months post-intervention | 
| Document change in lower limb muscle strength | Lower limb muscle strength will be assessed with a timed Sit-to-Stand test (scores are measured in seconds, with a lower time indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in walking speed | Walking speed will be assessed with a 10-meter walking test (scores are measured in seconds, with a lower time indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes functional mobility | Functional mobility will be assessed with the Timed up and Go test (scores are measured in seconds, with a lower time indicating a better score). | Baseline and 6 months post-intervention | 
| Document changes in cardiorespiratory fitness | Cardiorespiratory fitness will be assessed with the Matthews cardiorespiratory fitness questionnaire (the score is an estimation of individual VO2 max (ml.kg.min) and ranges from 15-50, with a higher score indicating a higher VO2max). | Baseline and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Primary Progressive Aphasia, Home-Based Exercise Intervention, Pilot Study