"SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.
The University of Texas Health Science Center at San Antonio
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.
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 movem…
Eligibility
- Age range
- 35–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult S-VWP between \>35-90 years of age 2. Diagnosis of Idiopathic Parkinson's Disease \[IDP\] (either or suspected, tremor-predominant or rigid predominant) 3. Disability level of Hoehn \& Yahr stages II-III as indicated in their most recent neurological evaluation 4. Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \[MDS-UPDRS\]- 5. ADL swallowing item \>0, or Mann Assessment of Swallowing scale \[MASA\] score ≤185. 6. Able to consume oral nutrition \[Functional Oral Intake Score ≤ 6\] 7. Ambulatory 8. No change of medication for at le…
Interventions
- BehavioralSwallowFit
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.
Location
- Brooke Army Medical Center (BAMC)San Antonio, Texas