"SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 80
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Study investigators (PI, Co-I's, and Biostatistician), study coordinator and the Independent Evaluator, will be blind to the treatment allocation of the subjects. The PI will evaluate de-identified videoed assessments, and swallowing videofluoroscopic data.
Eligibility Criteria
- Ages
- 35 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult S-VWP between \>35-90 years of age
- •Diagnosis of Idiopathic Parkinson's Disease \[IDP\] (either or suspected, tremor-predominant or rigid predominant)
- •Disability level of Hoehn \& Yahr stages II-III as indicated in their most recent neurological evaluation
- •Swallowing concern, confirmed by Modified Unified Parkinson Disease Rating Scale \[MDS-UPDRS\]-
- •ADL swallowing item \>0, or Mann Assessment of Swallowing scale \[MASA\] score ≤
- •Able to consume oral nutrition \[Functional Oral Intake Score ≤ 6\]
- •No change of medication for at least 4 weeks before study inclusion
Exclusion Criteria
- •Classified as Hoehn and Yahr stages IV
- •Unable to follow 2 step commands
- •History of other neurological disease potentially causing dysphagia
- •Dementia (MMSE\<20; Montreal cognitive assessment (MoCA) ≤ 20)
- •Severe depression (BDI\>19)
- •Severe dyskinesia of head and neck (resulting in problems with MBSS recording)
- •Severe documented Gastrointestinal disease
- •History of Gastro-esophageal surgery
- •History of Head or neck cancer with swallowing impairment or surgical intervention
- •History of breathing disorders or diseases (e.g., Asthma, chronic obstructive pulmonary disease (COPD) requiring assistive breathing support.
Investigators
Giselle Carnaby
Professor
The University of Texas Health Science Center at San Antonio