The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
1 other identifier
interventional
9
1 country
1
Brief Summary
Swallowing impairment (dysphagia) is extremely common in older adults living with dementia due to age-related changes in swallowing and other disease-specific impairments. Dysphagia is commonly managed by modifying diet textures rather than engaging in rehabilitative swallowing therapy. This means that countless people with dementia are left to eat pureed foods and drink thickened liquids, which are unpalatable and lead to malnutrition. As the disease progresses, many are transferred to nursing homes. In Canada, speech-language pathologists, who manage dysphagia, are consultants within nursing homes; therefore, swallowing therapy is non-existent. However, exercise therapy is more commonly available. Rodent models have demonstrated that physical exercise strengthens tongue and vocal-fold musculature, which are critical components of swallowing. Therefore, it is possible that whole-body physical exercise, which increases rate of respiration, will help to strengthen swallowing-related musculature in older adults with dementia. In this study, older adults (65+) with early-stage dementia will complete a 12-week physical exercise program to determine improvement of swallowing function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2020
CompletedFirst Posted
Study publicly available on registry
April 24, 2020
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedFebruary 6, 2023
February 1, 2023
1.4 years
April 21, 2020
February 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in respiratory function from baseline to end of intervention
Measure via peak cough flow using a peak flow meter
baseline, week 4, week 14 and week 16
Change in swallowing function from baseline to end of intervention
Measure via isometric tongue strength using an Iowa Oral Performance Instrument
baseline, week 4, week 14 and week 16
Secondary Outcomes (1)
Change in aerobic fitness from baseline to end of intervention
baseline, week 4, week 14 and week 16
Study Arms (1)
Whole-body exercise
EXPERIMENTALInterventions
10-week one-on-one, virtual, whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises.
Eligibility Criteria
You may qualify if:
- \> 59 years of age
- able to walk independently with or without an assistive device for a distance of at least 10 meters
- able to be active for 60 minutes with rest breaks
- abe to independently follow directions
- not involved in active rehabilitation
- a diagnosis of a progressive neurologic disease
- a maximum value for tongue strength \<40 kPa
You may not qualify if:
- neurological conditions other than a progressive neurologic disease
- significant cardiovascular conditions
- severe aphasia
- pain, other medical conditions or behavioural issues that would limit safe participation in the exercise program
- individuals with known structural causes of dysphagia
- individuals with known allergies to latex
- individuals receiving swallowing rehab
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- McMaster Universitylead
- Joseph Brant Hospitalcollaborator
Study Sites (1)
McMaster University
Hamilton, Ontario, Canada
Related Publications (2)
Kletzien H, Russell JA, Connor NP. The effects of treadmill running on aging laryngeal muscle structure. Laryngoscope. 2016 Mar;126(3):672-7. doi: 10.1002/lary.25520. Epub 2015 Aug 8.
PMID: 26256100BACKGROUNDKletzien H, Russell JA, Leverson GE, Connor NP. Differential effects of targeted tongue exercise and treadmill running on aging tongue muscle structure and contractile properties. J Appl Physiol (1985). 2013 Feb 15;114(4):472-81. doi: 10.1152/japplphysiol.01370.2012. Epub 2012 Dec 20.
PMID: 23264540BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2020
First Posted
April 24, 2020
Study Start
May 1, 2021
Primary Completion
September 30, 2022
Study Completion
September 30, 2022
Last Updated
February 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share