Motor Imagery Exercise and Tongue Strength
The Effects of a Motor Imagery Exercise Program on Tongue Strength
1 other identifier
interventional
40
1 country
1
Brief Summary
This research study is a six-week treatment pilot study to compare the effects of different exercise types on measures of tongue strength and swallowing pressure in typically aging older adults. Typically-aging older adults represent a group "at risk" for dysphagia secondary to sarcopenia of striated musculature important to swallowing. Participants at all study sites will be randomly selected into one of four study exercise groups. At some study sites, the investigators will also determine cortical activation patterns differences during motor execution and motor imagery of tongue exercises between the groups using near-infrared spectroscopy. The results of this study will inform refinement/further development of the mental practice protocol to use with patients with dysphagia in future studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 19, 2017
CompletedFirst Submitted
Initial submission to the registry
January 15, 2018
CompletedFirst Posted
Study publicly available on registry
February 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedApril 17, 2019
October 1, 2018
2 years
January 15, 2018
April 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Tongue strength change
Maximum tongue strength as measured using the Iowa Oral Performance Instrument.
Change from baseline tongue strength at 6 weeks
Secondary Outcomes (1)
Swallowing pressure change
Change from baseline swallowing pressure strength at 6 weeks
Other Outcomes (1)
Cortical activation pattern change
Change from baseline tongue relative percent change in oxygenation at 6 weeks
Study Arms (4)
Active Jaw Exercise with Relaxation
PLACEBO COMPARATORParticipants randomized to this arm will complete active jaw exercises and visualization relaxation exercise (control group).
Active Tongue Exercise
ACTIVE COMPARATORParticipants randomized to this arm will complete active tongue exercises only.
Active Tongue Exercise + Mental Practice
EXPERIMENTALParticipants randomized to this arm will complete active tongue exercises and mental practice of tongue exercise via motor imagery.
Mental Practice Tongue Exercise
EXPERIMENTALParticipants randomized to this arm will complete mental practice of tongue exercise via motor imagery only.
Interventions
This is the control group that will complete exercises unrelated to the primary outcome measures.
This is the active comparator group that will complete exercises already shown to increase tongue strength measures.
This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.
This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.
Eligibility Criteria
You may qualify if:
- Adults aged 60-89
- \< 3 on EAT-10 (Eating Assessment Tool-10) (part of health questionnaire)
- Mean of ≥2.5 on the KVIQ-10 questions (Kinesthetic and Visual Imagery Questionnaire, short version), a screening questionnaire that assesses a person's motor imagery abilities
- \> 24 on MMSE (Mini Mental State Examination), a screening questionnaire that assesses cognitive abilities
- Availability to complete a consecutive 6-week exercise regimen
- Access to reliable transportation to and from study site for in-person experimental sessions
- There are certain conditions that are common to the aging study population we are recruiting which will be acceptable: controlled hypertension and controlled diabetes mellitus
You may not qualify if:
- History of diagnosed dysphagia (swallowing disorder)
- History of a seizure(s)
- Current or past problem with pain disorders involving the jaw muscles or joint of the mandible (e.g., TMJ (temporomandibular) disorder or myofacial pain disorder) - these are contraindicated for tongue strengthening exercises
- Presence of oral piercings/oral apparatus that may interfere with tongue exercises
- Medical conditions that would affect oral motor performance (e.g., history of acute or degenerative neurological condition, head/neck cancer), as determined by investigator
- History of a diagnosed dementia or other cognitive impairment
- Uncontrolled high blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of South Floridalead
- James Madison Universitycollaborator
- Texas Christian Universitycollaborator
- Loma Linda Universitycollaborator
Study Sites (1)
Sarah Hegyi Szynkiewicz, PhD, CCC-SLP
Sarasota, Florida, 34243, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah Hegyi Szynkiewicz, PhD
USF Sarasota-Manatee
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2018
First Posted
February 6, 2018
Study Start
December 19, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
April 17, 2019
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- De-identified data will be shared from the beginning of enrollment between universities using a password secure Box account and only de-identified data will be kept after the project ends.
- Access Criteria
- De-identified data will be shared from the beginning of enrollment between universities using a password secure Box account to which all investigators have access.
The privacy and confidentiality of the participants will be maintained. Each participant's identity will be disassociated from the participant's personal data - a subject number will be assigned to each participant upon signing of the informed consent. De-identified data will be shared between universities using a secure and password protected account.