The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia

Parkinson Disease Clinical Trial

Official title:

The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04362228
• Other study ID #: REB project #10638
• Status: Completed
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: September 30, 2022

Study information

• Verified date: February 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cough
• Deglutition Disorders
• Dementia
• Neuro-Degenerative Disease
• Neurodegenerative Diseases
• Old Age; Dementia
• Parkinson Disease
• Swallowing Disorder

Intervention

Behavioral:
• Whole-body exercise
10-week one-on-one, virtual, whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Joseph Brant Hospital

Country where clinical trial is conducted

Canada, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in aerobic fitness from baseline to end of intervention	Measure via physical capacity using the 6-minute walk test	baseline, week 4, week 14 and week 16