SwallowFIT Study in Parkinson's Disease

NCT07356414 | Not Yet Recruiting DMC

• 2 other identifiers: STUDY00001444FY24 HT942524PRPIIRA
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

PARKINSON DISEASE (Disorder)

Keywords

Swallowing; US Service members; Veterans; SwallowFIT

Outcome Measures

Primary Outcomes (5)

• Mann Assessment of Swallowing Ability (MASA)

  The MASA score is measured using a 5-point to 10-point rating scale. The total possible score of the MASA is 200 points, and the cutoff value is 177 points. The results of the MASA are interpreted as no abnormality (≥178), mild dysphagia (168-177), moderate dysphagia (139-167), and severe dysphagia (≤138).

  Baseline to 6 months

• Modified Unified Parkinson Disease Rating Scale (MDS-UPDRS)

  The MDS-UPDRS uses a 0-4 scoring system, with higher scores indicating more severe symptoms. Parts I-III are scored on a 0-4 scale, while Part IV uses "yes" and "no" ratings. The total score range is 0-260, with 0 representing no disability and 260 representing total disability.

  Baseline to 6 months

• Modified Hoehn and Yahr (HY) Scale

  The Hoehn and Yahr (H\&Y) scale is a grading system used to assess the progression and severity of motor symptoms in Parkinson's disease (PD). It ranges from Stage 0 (no signs of disease) to Stage 5 (severe disability, wheelchair or bed bound). Stages 1, 1.5, 2, and 2.5 are considered early stages, while stages 3, 4, and 5 represent later, more advanced stages.

  Baseline to 6 months

• Montreal Cognitive Assessment (MoCA)

  The Montreal Cognitive Assessment (MoCA) is a cognitive screening tool with a maximum score of 30 points, with a score of 26 or higher generally indicating normal cognitive function. Scores between 18 and 25 may suggest mild cognitive impairment (MCI), while scores below 18 may indicate moderate to severe impairment.

  Baseline to 6 months

• PD Quality of Life Scale (PDQ-39)

  The PDQ-39 is a questionnaire used to assess the impact of Parkinson's disease on quality of life. It consists of 39 questions, each rated on a 5-point scale from 0 (never) to 4 (always). Scores for the 39 questions are added to obtain a total score. The scores for the 8 subscales (mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and physical discomfort) are obtained by summing the scores for the relevant questions within each subscale. The total score and subscale scores range from 0 to 100, with higher scores indicating a greater impact of Parkinson's disease on quality of life.

  Baseline to 6 months

Secondary Outcomes (10)

• Modified Barium Swallowing Impairment Profile, overall impression score (MBSImp OI score)

  Baseline to 6 months

• Spontaneous Swallowing Frequency (SSF)

  Baseline to 6 months

• Penetration Aspiration Scale (PAS)

  Baseline to 6 months

• Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT)

  Baseline to 6 months

• Functional Oral Intake Scale (FOIS)

  Baseline to 6 months

Study Arms (2)

SwallowFit Intervention

EXPERIMENTAL

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.

Behavioral: SwallowFit

Clinical Monitoring Only (CMO)

NO INTERVENTION

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.

Interventions

SwallowFit BEHAVIORAL

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.

Also known as: Swallowing exercises

SwallowFit Intervention

Eligibility Criteria

• Age: 35 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤185.
• Able to consume oral nutrition \[Functional Oral Intake Score ≤ 6\]
• Ambulatory

You may not qualify if:

• 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.
• Untreated hypertension
• Heart disease requiring restricted activity and medical intervention
• Speech therapy intervention for swallowing within the past three months
• Women who are pregnant, nursing, or who plan to become pregnant during the study

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• United States Department of Defense: collaborator

Study Sites (1)

Brooke Army Medical Center (BAMC)

San Antonio, Texas, 78234-6200, United States

Location

Related Links

• Lab website for Principle Investigator regarding the study.

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Giselle Carnaby, PhD, MP

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giselle Carnaby, PhD, MPH

CONTACT

210-450-7130; carnaby@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single site, double blind randomized controlled trial comparing a proactive swallow exercise intervention to a control group receiving clinical monitoring only (or CMO).

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): June 29, 2028
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the study is complete and unblinded, the study team will submit all remaining scientific data to the data repository, and we will update the study status to "completed" in clinical trials.gov. According to the study timeline, all generated scientific data will approximately coincide with the submission of the results to clinicaltrials.gov and will occur no later than by the end of award. Scientific data included in published manuscripts will be available at the time of publication. According to the proposed project timeline, all generated scientific data will approximately coincide with the submission of the results to clinicaltrials.gov at the end of the award, and full data sharing (via repository) will occur no later than six months after completion of the study or acceptance for publication of the main findings from the final dataset.

Locations

US (1)