AzTrials
AzTrials

Primary Progressive AphasiaHEPPANCT06181500

Home-Based Exercise in Primary Progressive Aphasia (HEPPA)

A study testing Home-based multicomponent exercise intervention program in people with Primary Progressive Aphasia and Neurodegenerative Diseases, run by Montreal Heart Institute at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Any age
What is being tested?
Home-based multicomponent exercise intervention program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesCanada
Study dates
5 Apr 2023to 31 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

    Montreal, Quebec, H1T 1N6

  • McGill University Research Centre for Studies in Aging (MCSA)

    Montreal, Quebec, H4H 1R3

Other trials in Canada

About this study

Official title: 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

Read the 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.

Being tested
Home-based multicomponent exercise intervention program
Keywords
Primary Progressive Aphasia, Home-Based Exercise Intervention, Pilot Study
Medical subject headings
Aphasia, Primary Progressive, Neurodegenerative Diseases, Frontotemporal Dementia, Aphasia, Broca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Home-based multicomponent exercise intervention programOther

    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).

Study groups in NCT06181500
Study groupRoleWhat they receive
Home-based multicomponent exercise intervention programExperimentalNot described
Receives: Other: Home-based multicomponent exercise intervention program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 6 months post-intervention

  2. 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)

    Measured: 6 months post-intervention

  3. 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)

    Measured: 6 months post-intervention

  4. 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)

    Measured: 6 months post-intervention

  5. 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.

    Measured: 6 months post-intervention

Secondary outcomes (20)
  1. 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).

    Measured: Baseline and 6 months post-intervention

  2. 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).

    Measured: Baseline and 6 months post-intervention

  3. 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).

    Measured: Baseline and 6 months post-intervention

  4. 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).

    Measured: Baseline and 6 months post-intervention

  5. 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).

    Measured: Baseline and 6 months post-intervention

  6. 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).

    Measured: Baseline and 6 months post-intervention

  7. 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).

    Measured: Baseline and 6 months post-intervention

  8. Document changes in reading comprehension

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

    Measured: Baseline and 6 months post-intervention

  9. 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).

    Measured: Baseline and 6 months post-intervention

  10. 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).

    Measured: Baseline and 6 months post-intervention

  11. 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).

    Measured: Baseline and 6 months post-intervention

  12. 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).

    Measured: Baseline and 6 months post-intervention

  13. 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).

    Measured: Baseline and 6 months post-intervention

  14. 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).

    Measured: Baseline and 6 months post-intervention

  15. 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).

    Measured: Baseline and 6 months post-intervention

  16. 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).

    Measured: Baseline and 6 months post-intervention

  17. 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).

    Measured: Baseline and 6 months post-intervention

  18. 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).

    Measured: Baseline and 6 months post-intervention

  19. 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).

    Measured: Baseline and 6 months post-intervention

  20. 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).

    Measured: Baseline and 6 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2023
  2. Study start5 Apr 2023
  3. Primary completion1 Jun 2024
  4. Study completion31 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06181500
Sponsor's protocol ID
MP-33-2022-3114
Acronym
HEPPA
Status last verified
Dec 2023
First submitted
19 Nov 2023
Last updated
6 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Angevaren M, Vanhees L, Wendel-Vos W, Verhaar HJ, Aufdemkampe G, Aleman A, Verschuren WM. Intensity, but not duration, of physical activities is related to cognitive function. Eur J Cardiovasc Prev Rehabil. 2007 Dec;14(6):825-30. doi: 10.1097/HJR.0b013e3282ef995b.

    PubMed 18043306
  • Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Plymate SR, Fishel MA, Watson GS, Cholerton BA, Duncan GE, Mehta PD, Craft S. Effects of aerobic exercise on mild cognitive impairment: a controlled trial. Arch Neurol. 2010 Jan;67(1):71-9. doi: 10.1001/archneurol.2009.307.

    PubMed 20065132
  • Bherer L, Erickson KI, Liu-Ambrose T. A review of the effects of physical activity and exercise on cognitive and brain functions in older adults. J Aging Res. 2013;2013:657508. doi: 10.1155/2013/657508. Epub 2013 Sep 11.

    PubMed 24102028
  • Blondell SJ, Hammersley-Mather R, Veerman JL. Does physical activity prevent cognitive decline and dementia?: A systematic review and meta-analysis of longitudinal studies. BMC Public Health. 2014 May 27;14:510. doi: 10.1186/1471-2458-14-510.

    PubMed 24885250
  • Borst SE, De Hoyos DV, Garzarella L, Vincent K, Pollock BH, Lowenthal DT, Pollock ML. Effects of resistance training on insulin-like growth factor-I and IGF binding proteins. Med Sci Sports Exerc. 2001 Apr;33(4):648-53. doi: 10.1097/00005768-200104000-00021.

    PubMed 11283443
  • Casaletto KB, Staffaroni AM, Wolf A, Appleby B, Brushaber D, Coppola G, Dickerson B, Domoto-Reilly K, Elahi FM, Fields J, Fong JC, Forsberg L, Ghoshal N, Graff-Radford N, Grossman M, Heuer HW, Hsiung GY, Huey ED, Irwin D, Kantarci K, Kaufer D, Kerwin D, Knopman D, Kornak J, Kramer JH, Litvan I, Mackenzie IR, Mendez M, Miller B, Rademakers R, Ramos EM, Rascovsky K, Roberson ED, Syrjanen JA, Tartaglia MC, Weintraub S, Boeve B, Boxer AL, Rosen H, Yaffe K; ARTFL/LEFFTDS Study. Active lifestyles moderate clinical outcomes in autosomal dominant frontotemporal degeneration. Alzheimers Dement. 2020 Jan;16(1):91-105. doi: 10.1002/alz.12001.

    PubMed 31914227
  • Cassilhas RC, Viana VA, Grassmann V, Santos RT, Santos RF, Tufik S, Mello MT. The impact of resistance exercise on the cognitive function of the elderly. Med Sci Sports Exerc. 2007 Aug;39(8):1401-7. doi: 10.1249/mss.0b013e318060111f.

    PubMed 17762374
  • Cheng ST, Chow PK, Song YQ, Yu EC, Chan AC, Lee TM, Lam JH. Mental and physical activities delay cognitive decline in older persons with dementia. Am J Geriatr Psychiatry. 2014 Jan;22(1):63-74. doi: 10.1016/j.jagp.2013.01.060. Epub 2013 Feb 6.

    PubMed 23582750
  • Colcombe SJ, Erickson KI, Scalf PE, Kim JS, Prakash R, McAuley E, Elavsky S, Marquez DX, Hu L, Kramer AF. Aerobic exercise training increases brain volume in aging humans. J Gerontol A Biol Sci Med Sci. 2006 Nov;61(11):1166-70. doi: 10.1093/gerona/61.11.1166.

    PubMed 17167157
  • Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430.

    PubMed 12661673
  • Duffy JR, Strand EA, Clark H, Machulda M, Whitwell JL, Josephs KA. Primary progressive apraxia of speech: clinical features and acoustic and neurologic correlates. Am J Speech Lang Pathol. 2015 May;24(2):88-100. doi: 10.1044/2015_AJSLP-14-0174.

    PubMed 25654422
  • Eikelboom WS, Janssen N, Jiskoot LC, van den Berg E, Roelofs A, Kessels RPC. Episodic and working memory function in Primary Progressive Aphasia: A meta-analysis. Neurosci Biobehav Rev. 2018 Sep;92:243-254. doi: 10.1016/j.neubiorev.2018.06.015. Epub 2018 Jun 18.

    PubMed 29928907
  • Foxe D, Irish M, Hu A, Carrick J, Hodges JR, Ahmed RM, Burrell JR, Piguet O. Longitudinal cognitive and functional changes in primary progressive aphasia. J Neurol. 2021 May;268(5):1951-1961. doi: 10.1007/s00415-020-10382-9. Epub 2021 Jan 8.

    PubMed 33417000
  • Gorno-Tempini ML, Hillis AE, Weintraub S, Kertesz A, Mendez M, Cappa SF, Ogar JM, Rohrer JD, Black S, Boeve BF, Manes F, Dronkers NF, Vandenberghe R, Rascovsky K, Patterson K, Miller BL, Knopman DS, Hodges JR, Mesulam MM, Grossman M. Classification of primary progressive aphasia and its variants. Neurology. 2011 Mar 15;76(11):1006-14. doi: 10.1212/WNL.0b013e31821103e6. Epub 2011 Feb 16.

    PubMed 21325651
  • Gorno-Tempini ML, Dronkers NF, Rankin KP, Ogar JM, Phengrasamy L, Rosen HJ, Johnson JK, Weiner MW, Miller BL. Cognition and anatomy in three variants of primary progressive aphasia. Ann Neurol. 2004 Mar;55(3):335-46. doi: 10.1002/ana.10825.

    PubMed 14991811

Questions about this trial

What is this clinical trial studying?

A study testing Home-based multicomponent exercise intervention program in people with Primary Progressive Aphasia and Neurodegenerative Diseases, run by Montreal Heart Institute at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the total recruitment rate of a 6-month exercise intervention in individuals with Primary Progressive Aphasia (time frame: 6 months post-intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06181500, which also lists 42 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025; AzTrials last refreshed its copy on 27 Oct 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in