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

Sponsor

McMaster University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04362228

Collaborator

Joseph Brant Hospital (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Old Age; Dementia Swallowing Disorder Cough Parkinson Disease Neuro-Degenerative Disease	Behavioral: Whole-body exercise	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Sep 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Whole-body exercise	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.

Arm

Intervention/Treatment

Experimental: Whole-body exercise

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.

Outcome Measures

Primary Outcome Measures

Change in respiratory function from baseline to end of intervention [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 [baseline, week 4, week 14 and week 16]
Measure via isometric tongue strength using an Iowa Oral Performance Instrument

Secondary Outcome Measures

Change in aerobic fitness from baseline to end of intervention [baseline, week 4, week 14 and week 16]
Measure via physical capacity using the 6-minute walk test

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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