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Completed

NCT Number: NCT04362228

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

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.

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Key information

Conditions

Old Age; Dementia Alzheimer Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Cough Deglutition Disorders Dementia Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Mental Disorders Motor Activity Movement Disorders Nervous System Diseases Neuro-Degenerative Disease Neurocognitive Disorders Neurodegenerative Diseases Otorhinolaryngologic Diseases Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Swallowing Disorder Synucleinopathies Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole-body exercise

Behavioral

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in aerobic fitness from baseline to end of intervention

    Time frame: baseline, week 4, week 14 and week 16

    Measure via physical capacity using the 6-minute walk test

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Joseph Brant Hospital

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 24, 2020
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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