Home-Based Exercise in Primary Progressive Aphasia (HEPPA)

NCT06181500 | Completed

• 1 other identifier: MP-33-2022-3114
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 2

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

Conditions

Primary Progressive Aphasia; Neurodegenerative Diseases; Logopenic Progressive Aphasia; Semantic Dementia; Non-fluent Aphasia

Keywords

Primary Progressive Aphasia; Home-Based Exercise Intervention; Pilot Study

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• Document changes in general cognitive functioning

  Baseline and 6 months post-intervention

• Document changes in auditory long-term memory

  Baseline and 6 months post-intervention

• Document changes in visual long-term memory

  Baseline and 6 months post-intervention

• Document changes in verbal working memory

  Baseline and 6 months post-intervention

• Document changes in visual working memory

  Baseline and 6 months post-intervention

Other Outcomes (10)

• Document changes in quality-of-life

  Baseline and 6 months post-intervention

• Document changes in depressive symptomatology

  Baseline and 6 months post-intervention

• Document changes in anxiety

  Baseline and 6 months post-intervention

Study Arms (1)

Home-based multicomponent exercise intervention program

EXPERIMENTAL

Other: Home-based multicomponent exercise intervention program

Interventions

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).

Home-based multicomponent exercise intervention program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (2)

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

Location

McGill University Research Centre for Studies in Aging (MCSA)

Montreal, Quebec, H4H 1R3, Canada

Location

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MeSH Terms

Conditions

Aphasia, Primary Progressive; Neurodegenerative Diseases; Frontotemporal Dementia; Aphasia, Broca

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Louis Bherer

  Centre ÉPIC, Institut de cardiologie de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the EPIC Center and Scientist, Montreal Heart Institute

Study Record Dates

• First Submitted: November 19, 2023
• First Posted: December 26, 2023
• Study Start: April 5, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 31, 2024
• Last Updated: February 6, 2025

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)