SwallowFIT Study in Parkinson's Disease

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: PARKINSON DISEASE (Disorder)

Treatments: Behavioral: SwallowFit

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07356414

STUDY00001444

FY24 HT942524PRPIIRA (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 35 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

SwallowFit Intervention

Experimental group

Description:

Subjects randomized to intervention will receive 6-weeks of twice weekly SwallowFIT per protocol (1-hour session each day). The program 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 surface electromyographic (sEMG) biofeedback to guide the development of better swallow movement form, effort and performance. From there it applies a hierarchy of swallowing exercises/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.

Treatment:

Behavioral: SwallowFit

Clinical Monitoring Only (CMO)

No Intervention group

Description:

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 if an obvious issue has been identified. Subjects randomized to CMO will also receive general education on swallowing and swallow changes from the Parkinson's Foundation and Michael J Fox association websites.