Old Age; DementiaNCT04362228
The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
A study testing Whole-body exercise in people with Old Age; Dementia and Swallowing Disorder, run by McMaster University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Old Age; Dementia, Swallowing Disorder, Cough
- What is being tested?
- Whole-body exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 30 Sep 2022
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Old Age; Dementia, Swallowing Disorder, Cough, Parkinson Disease, Neuro-Degenerative Disease
- Being tested
- Whole-body exercise
- Keywords
- dementia, swallowing, physical exercise, parkinson disease
- Medical subject headings
- Alzheimer Disease, Deglutition Disorders, Cough, Parkinson Disease, Dementia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-body exerciseBehavioural
10-week one-on-one, virtual, whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises.
| Study group | Role | What they receive |
|---|---|---|
| Whole-body exercise | Experimental | Not described Receives: Behavioral: Whole-body exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in respiratory function from baseline to end of intervention
Measure via peak cough flow using a peak flow meter
Measured: 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
Measured: baseline, week 4, week 14 and week 16
Secondary outcomes (1)
Change in aerobic fitness from baseline to end of intervention
Measure via physical capacity using the 6-minute walk test
Measured: baseline, week 4, week 14 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start1 May 2021
- Primary completion30 Sep 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Old Age; DementiaStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Joseph Brant Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04362228
- Sponsor's protocol ID
- REB project #10638
- Status last verified
- Feb 2023
- First submitted
- 21 Apr 2020
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26256100Kletzien 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.
PubMed 23264540
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT04362228
- Acronym / sponsor ID
- REB project #10638
- Conditions
- Old Age; Dementia, Swallowing Disorder, Cough, Parkinson Disease, Neuro-Degenerative Disease
- Keywords
- dementia, swallowing, physical exercise, parkinson disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Joseph Brant Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole-body exercise | Experimental | Behavioral: Whole-body exercise |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- > 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-body exercise10-week one-on-one, virtual, whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises. | Behavioural | Whole-body exercise |
Primary outcome
Change in respiratory function from baseline to end of intervention
Time frame: baseline, week 4, week 14 and week 16
Measure via peak cough flow using a peak flow meter
Change in swallowing function from baseline to end of intervention
Time frame: baseline, week 4, week 14 and week 16
Measure via isometric tongue strength using an Iowa Oral Performance Instrument
1 secondary outcome
Change in aerobic fitness from baseline to end of intervention
Time frame: baseline, week 4, week 14 and week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Background: PubMed 26256100Kletzien 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.
- Background: PubMed 23264540Kletzien 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-body exercise in people with Old Age; Dementia and Swallowing Disorder, run by McMaster University at 1 site 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 7 inclusion and 7 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 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in respiratory function from baseline to end of intervention (time frame: baseline, week 4, week 14 and week 16). The study lists 2 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 NCT04362228, which also lists 2 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 2023.