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SwallowFIT Study in Parkinson's Disease

Not Yet RecruitingNA

Sponsor: The University of Texas Health Science Center at San Antonio

Conditions: PARKINSON DISEASE (Disorder)

Interventions: SwallowFit

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 35 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 least 4 weeks before study inclusion

Exclusion Criteria:

1. Classified as Hoehn and Yahr stages IV
2. Unable to follow 2 step commands
3. History of other neurological disease potentially causing dysphagia
4. Dementia (MMSE\<20; Montreal cognitive assessment (MoCA) ≤ 20)
5. Severe depression (BDI\>19)
6. Severe dyskinesia of head and neck (resulting in problems with MBSS recording)
7. Severe documented Gastrointestinal disease
8. History of Gastro-esophageal surgery
9. History of Head or neck cancer with swallowing impairment or surgical intervention
10. History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.
11. Untreated hypertension
12. Heart disease requiring restricted activity and medical intervention
13. Speech therapy intervention for swallowing within the past three months
14. Women who are pregnant, nursing, or who plan to become pregnant during the study

Locations (1)

San Antonio, Texas, United States