NCT04362228

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.4 years

First QC Date

April 21, 2020

Last Update Submit

February 3, 2023

Conditions

Keywords

dementiaswallowingphysical exerciseparkinson disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change in aerobic fitness from baseline to end of intervention

    baseline, week 4, week 14 and week 16

Study Arms (1)

Whole-body exercise

EXPERIMENTAL
Behavioral: Whole-body exercise

Interventions

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

Whole-body exercise

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McMaster University

Hamilton, Ontario, Canada

Location

Related 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.

    PMID: 26256100BACKGROUND
  • 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.

    PMID: 23264540BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDeglutition DisordersCoughParkinson DiseaseDementiaMotor Activity

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2020

First Posted

April 24, 2020

Study Start

May 1, 2021

Primary Completion

September 30, 2022

Study Completion

September 30, 2022

Last Updated

February 6, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations