Clinical trial NCT03423095: Motor Imagery Exercise and Tongue Strength
Official title: The Effects of a Motor Imagery Exercise Program on Tongue Strength
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: James Madison University
name: Texas Christian University
name: Loma Linda University
First posted: 2018-02-06
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Although motor imagery (MI) has not yet been researched in the field of swallowing rehabilitation, the potential benefit is far reaching. Difficulty swallowing, or dysphagia, can occur in people who have a history of stroke, head injury, neurological disease (such as Parkinson's disease, ALS, etc.), and head/neck cancer. A person with dysphagia may have difficulty eating everyday foods and may require an altered diet, such as tube feedings or pureed foods. Because of this, having dysphagia is often associated with increased feelings of isolation and depression. Speech-language pathologists work with people with dysphagia to rehabilitate their swallow, with the goal of reducing their risk of choking and improving their ability to eat normal foods. The use of MI as a way to augment dysphagia rehabilitation has implications for patients who aren't safe to have any food by mouth as well as those who fatigue easily.

This research study is a six-week treatment pilot study to determine the effect of motor imagery for tongue strengthening exercises 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 groups: 1) placebo (active jaw open against resistance/close against resistance/lateralize/protrusion exercises with relaxation exercises), 2) active tongue exercises against resistance only, 3) active tongue exercises against resistance + motor imagery of tongue exercises against resistance, and 4) motor imagery of tongue exercises against resistance only. In some participants 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.

The research questions are as follows:

1. Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise improve tongue strength in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises?
2. Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise improve swallowing pressures in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises?
3. Does a 6 week treatment of motor imagery tongue exercises with or without active tongue exercise alter cortical hemodynamic response patterns in healthy older adults compared to a 6 week treatment of placebo exercises and 6 week treatment of active tongue strengthening exercises? (JMU participants only).

The investigators hypothesize, based on previous research, that the group receiving both active and MI treatment will make the most gains in all three measures, followed by the active only group, then the MI only group, then the placebo group (control).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Tongue strength change
timeFrame: Change from baseline tongue strength at 6 weeks
Secondary outcomes:
measure: Swallowing pressure change
timeFrame: Change from baseline swallowing pressure strength at 6 weeks
Other outcomes:
measure: Cortical activation pattern change
timeFrame: Change from baseline tongue relative percent change in oxygenation at 6 weeks
Locations:
city: Sarasota
country: United States
facility: Sarah Hegyi Szynkiewicz, PhD, CCC-SLP
state: Florida
Study officials:
affiliation: USF Sarasota-Manatee
name: Sarah Hegyi Szynkiewicz, PhD
role: PRINCIPAL_INVESTIGATOR
References: