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NCT Number: NCT06181500

Home-Based Exercise in Primary Progressive Aphasia (HEPPA)

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home-based multicomponent exercise intervention program

Other

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).

Primary outcomes

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

    Time frame: 6 months post-intervention

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

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

    Time frame: 6 months post-intervention

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

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

    Time frame: 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)

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

    Time frame: 6 months post-intervention

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

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

    Time frame: 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.

Secondary outcomes

  1. Document changes in general cognitive functioning

    Time frame: Baseline and 6 months post-intervention

    Participants will complete the Montreal Cognitive Assessment (scores range from 0-28, with a higher score indicating better cognitive functioning).

  2. Document changes in auditory long-term memory

    Time frame: Baseline and 6 months post-intervention

    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).

  3. Document changes in visual long-term memory

    Time frame: Baseline and 6 months post-intervention

    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).

  4. Document changes in verbal working memory

    Time frame: Baseline and 6 months post-intervention

    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).

  5. Document changes in visual working memory

    Time frame: Baseline and 6 months post-intervention

    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).

  6. Document changes in nonverbal fluency

    Time frame: Baseline and 6 months post-intervention

    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).

  7. Document changes in verbal fluency

    Time frame: Baseline and 6 months post-intervention

    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).

  8. Document changes in reading comprehension

    Time frame: Baseline and 6 months post-intervention

    Participants will complete the Chapman-Cook (scores range from 0-30, with a higher score indicating better reading comprehension).

  9. Document changes in writing ability

    Time frame: Baseline and 6 months post-intervention

    Participants will complete the Bernard Croisile dictation task (scores range from 0-18, with a higher score indicating better writing ability).

  10. Document changes in auditory comprehension

    Time frame: Baseline and 6 months post-intervention

    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).

  11. Document changes in oral expression

    Time frame: Baseline and 6 months post-intervention

    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).

  12. Document changes in lexical retrieval

    Time frame: Baseline and 6 months post-intervention

    Participants will complete the Boston Naming Test (scores range from 0-30, with a higher score indicating better lexical retrieval).

  13. Document changes in executive functions and processing speed

    Time frame: Baseline and 6 months post-intervention

    Participants will complete validated neuropsychological tests and iPad tests (scores are measured in milliseconds, with lower reaction times indicating faster processing speeds).

  14. Document changes in endurance

    Time frame: Baseline and 6 months post-intervention

    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).

  15. Document change in balance performance

    Time frame: Baseline and 6 months post-intervention

    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).

  16. Document change in upper limb muscle strength

    Time frame: Baseline and 6 months post-intervention

    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).

  17. Document change in lower limb muscle strength

    Time frame: Baseline and 6 months post-intervention

    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).

  18. Document changes in walking speed

    Time frame: Baseline and 6 months post-intervention

    Walking speed will be assessed with a 10-meter walking test (scores are measured in seconds, with a lower time indicating a better score).

  19. Document changes functional mobility

    Time frame: Baseline and 6 months post-intervention

    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).

  20. Document changes in cardiorespiratory fitness

    Time frame: Baseline and 6 months post-intervention

    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).

Other outcomes

  1. Document changes in quality-of-life

    Time frame: Baseline and 6 months post-intervention

    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.

  2. Document changes in depressive symptomatology

    Time frame: Baseline and 6 months post-intervention

    Geriatric Depression Scale questionnaire (scores range from 0-30, with a higher score indicating larger depressive symptomatology).

  3. Document changes in anxiety

    Time frame: Baseline and 6 months post-intervention

    State-Trait Anxiety Inventory questionnaire (scores range from 20-80, with a higher score indicating higher anxiety).

  4. Document changes in perceived stress

    Time frame: Baseline and 6 months post-intervention

    Perceived Stress Scale questionnaire (scores range from 0-4, with 0 no stress,1 mild stress, 3 moderate stress and 4 severe).

  5. Document changes in sleep quality

    Time frame: Baseline and 6 months post-intervention

    Pittsburg Sleep Quality Index questionnaire (scores range from 0-21, with a higher score indicating worse sleep quality).

  6. Document changes in risk of sleep apnea

    Time frame: Baseline and 6 months post-intervention

    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).

  7. Document changes in self-reported physical activity

    Time frame: Baseline and 6 months post-intervention

    Physical Activity Scale for the Elderly questionnaire (scores range from 0-400, with a higher score indicating better level of physical activity).

  8. Document changes in neuropsychiatric symptoms

    Time frame: Baseline and 6 months post-intervention

    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).

  9. Document Cognitive Reserve

    Time frame: Baseline

    Rami and colleagues' cognitive reserve questionnaire (scores range from 0-26, with a higher score indicating a greater cognitive reserve).

  10. Document perceived social support

    Time frame: Baseline

    Lubben Social Network Scale questionnaire (scores range from 0-30, with a higher score indicating more social engagement)

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Acronym: HEPPA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2023
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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