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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
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Old Age; Dementia focused on measuring dementia, swallowing, physical exercise, parkinson disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
April 21, 2020
Last Updated
February 3, 2023
Sponsor
McMaster University
Collaborators
Joseph Brant Hospital
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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
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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
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The Effects of Whole-body Exercise to Improve Swallowing Function in Older Adults With Dementia

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