The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
Primary Purpose
Old Age; Dementia, Swallowing Disorder, Cough
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Whole-body exercise
Sponsored by
About this trial
This is an interventional treatment trial for Old Age; Dementia focused on measuring dementia, swallowing, physical exercise, parkinson disease
Eligibility Criteria
Inclusion Criteria:
- > 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
Exclusion Criteria:
- 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
Sites / Locations
- McMaster University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Whole-body exercise
Arm Description
Outcomes
Primary Outcome Measures
Change in respiratory function from baseline to end of intervention
Measure via peak cough flow using a peak flow meter
Change in swallowing function from baseline to end of intervention
Measure via isometric tongue strength using an Iowa Oral Performance Instrument
Secondary Outcome Measures
Change in aerobic fitness from baseline to end of intervention
Measure via physical capacity using the 6-minute walk test
Full Information
NCT ID
NCT04362228
First Posted
April 21, 2020
Last Updated
February 3, 2023
Sponsor
McMaster University
Collaborators
Joseph Brant Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04362228
Brief Title
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
Official Title
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Joseph Brant Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Old Age; Dementia, Swallowing Disorder, Cough, Parkinson Disease, Neuro-Degenerative Disease
Keywords
dementia, swallowing, physical exercise, parkinson disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Whole-body exercise
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Whole-body exercise
Intervention Description
10-week one-on-one, virtual, whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises.
Primary Outcome Measure Information:
Title
Change in respiratory function from baseline to end of intervention
Description
Measure via peak cough flow using a peak flow meter
Time Frame
baseline, week 4, week 14 and week 16
Title
Change in swallowing function from baseline to end of intervention
Description
Measure via isometric tongue strength using an Iowa Oral Performance Instrument
Time Frame
baseline, week 4, week 14 and week 16
Secondary Outcome Measure Information:
Title
Change in aerobic fitness from baseline to end of intervention
Description
Measure via physical capacity using the 6-minute walk test
Time Frame
baseline, week 4, week 14 and week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
> 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
Exclusion Criteria:
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
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26256100
Citation
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.
Results Reference
background
PubMed Identifier
23264540
Citation
Kletzien 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.
Results Reference
background
Learn more about this trial
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
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