Home-Based Exercise in Primary Progressive Aphasia (HEPPA) (HEPPA)

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

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

Study Overview

• Status: Completed
• Conditions: Neurodegenerative Diseases; Primary Progressive Aphasia; Semantic Dementia; Logopenic Progressive Aphasia; Non-fluent Aphasia
• Intervention / Treatment: Other: Home-based multicomponent exercise intervention program

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H1T 1N6
      • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute
    • Montréal, Quebec, Canada, H4H 1R3
      • McGill University Research Centre for Studies in Aging (MCSA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Home-based multicomponent exercise intervention program

Other: Home-based multicomponent exercise intervention program; 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Document changes in quality-of-life	12-Item Short Form Health Survey. This questionnaire gives two scores - a mental component scale (MCS) and a physical component scale (PCS) score. Results are reported as Z-scores (mean of 50 and standard deviation of 10) and so each 10 increment of 10 points above or below 50, corresponds to one standard deviation away from the average.	Baseline and 6 months post-intervention
Document changes in depressive symptomatology	Geriatric Depression Scale questionnaire (scores range from 0-30, with a higher score indicating larger depressive symptomatology).	Baseline and 6 months post-intervention
Document changes in anxiety	State-Trait Anxiety Inventory questionnaire (scores range from 20-80, with a higher score indicating higher anxiety).	Baseline and 6 months post-intervention
Document changes in perceived stress	Perceived Stress Scale questionnaire (scores range from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).	Baseline and 6 months post-intervention
Document changes in sleep quality	Pittsburg Sleep Quality Index questionnaire (scores range from 0-21, with a higher score indicating worse sleep quality).	Baseline and 6 months post-intervention
Document changes in risk of sleep apnea	Using the Berlin Questionnaire, participants are classified into high risk or low risk based on their responses to the individual items and their overall scores in the symptom categories (high risk = if there are 2 or more categories where the score is positive/ low risk = if there are only 1 or no categories where the score is positive).	Baseline and 6 months post-intervention
Document changes in self-reported physical activity	Physical Activity Scale for the Elderly questionnaire (scores range from 0-400, with a higher score indicating better level of physical activity).	Baseline and 6 months post-intervention
Document changes in neuropsychiatric symptoms	The Neuropsychiatric Inventory-Questionnaire is completed by the participants' caregiver (scores range from 0-36 for symptom severity and from 0-60 for the caregiver's distress, with higher scores indicating higher severity/distress).	Baseline and 6 months post-intervention
Document Cognitive Reserve	Rami and colleagues' cognitive reserve questionnaire (scores range from 0-26, with a higher score indicating a greater cognitive reserve).	Baseline
Document perceived social support	Lubben Social Network Scale questionnaire (scores range from 0-30, with a higher score indicating more social engagement)	Baseline

Collaborators and Investigators

• Sponsor: Montreal Heart Institute
• Investigators: Principal Investigator: Louis Bherer, Centre ÉPIC, Institut de cardiologie de Montréal

Publications and helpful links

General Publications

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Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2023
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): August 31, 2024

Study Registration Dates

• First Submitted: November 19, 2023
• First Submitted That Met QC Criteria: December 12, 2023
• First Posted (Actual): December 26, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 4, 2025
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Pilot Study; Primary Progressive Aphasia; Home-Based Exercise Intervention
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Metabolic Diseases; Neurobehavioral Manifestations; Neurocognitive Disorders; Dementia; TDP-43 Proteinopathies; Proteostasis Deficiencies; Communication Disorders; Language Disorders; Speech Disorders; Frontotemporal Lobar Degeneration; Aphasia; Neurodegenerative Diseases; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain; Aphasia, Broca
• Other Study ID Numbers: MP-33-2022-3114

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No