NCT07356414

SwallowFIT Study in Parkinson's Disease

"SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 35 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if a proactive swallow exercise will help to improve swallow fitness in patients with Parkinson's disease. The aim of the study is to assess how effective this exercise is and to measure the change in swallowing fitness from the beginning to the end of the study. Patients who are given the exercise training will be compared to participants who are treated using the usual standard treatment. Patients will have 6 weeks of twice-weekly SwallowFIT training. Each session will be an hour long.

Detailed description

SwallowFIT: Subjects will receive 6-weeks of twice weekly SwallowFIT intervention per protocol (1-hour session each visit) from the BAMC speech language Pathologist (study SLP) at BAMC. Completion of the program will include 12 visits. The program is designed from a previous successful pilot trial. It begins with provision of general education on swallowing and swallowing change from the Parkinson's Foundation and Michael J Fox association websites. Following this the program trains a modified effortful swallow technique at its onset using sEMG to guide the development of better swallow movement form, effort and performance. Once swallowing form is established, the program uses a hierarchy of swallowing tasks involving swallowing food/fluid materials at different complexity levels (swallow specificity) to stimulate and train progressive resistance and leverage variability of coordinated speeded actions. Clinical Monitoring Only (CMO): This intervention mirrors the experimental intervention in all aspects, but the treatment type applied. CMO intervention reflects current swallow management practice for PD, where physicians monitor clinical function in swallowing and other related symptomology, referring for swallowing treatment only once an obvious issue has been identified.

Conditions

• PARKINSON DISEASE (Disorder)

Interventions

Type	Name	Description
BEHAVIORAL	SwallowFit	The SwallowFIT protocol follows an increasing task difficulty (levels on the hierarchy) and motor learning strategy. Progression on the hierarchy is guided and monitored by the occurrence of inefficiency markers in swallow wing (e.g. excessive lingual pumping, swallow hesitation, throat clearing etc.) confirmed from the baseline clinical and video fluoroscopic evaluations.

Timeline

• Start date: 2026-04-30
• Primary completion: 2028-03-30
• Completion: 2028-06-29
• First posted: 2026-01-21
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States