Neurodegenerative Diseases Clinical Trial
— HEPPAOfficial title:
Home-Based Exercise in Primary Progressive Aphasia: A Pilot Study
Verified date | December 2023 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This pilot study aims to evaluate the feasibility of a novel home-based multicomponent exercise program in adults clinically diagnosed with Primary Progressive Aphasia
Status | Active, not recruiting |
Enrollment | 13 |
Est. completion date | August 31, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Research Centre for Studies in Aging (MCSA) | Montréal | Quebec |
Canada | Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute |
Canada,
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* Note: There are 42 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | 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 | |
Other | Document Cognitive Reserve | Rami and colleagues' cognitive reserve questionnaire (scores range from 0-26, with a higher score indicating a greater cognitive reserve). | Baseline | |
Other | Document perceived social support | Lubben Social Network Scale questionnaire (scores range from 0-30, with a higher score indicating more social engagement) | Baseline | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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