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

February 3, 2023 updated by: McMaster University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • McMaster University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, week 4, week 14 and week 16
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
baseline, week 4, week 14 and week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, week 4, week 14 and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McMaster University

Collaborators

Joseph Brant Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2021

Primary Completion (ACTUAL)

September 30, 2022

Study Completion (ACTUAL)

September 30, 2022

Study Registration Dates

First Submitted

April 21, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (ACTUAL)

April 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 6, 2023

Last Update Submitted That Met QC Criteria

February 3, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB project #10638

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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