SwallowFIT Study in Parkinson's Disease

Official title

"SwallowFit," an Exercise Program and Randomized Clinical Trial Designed for US Service Members, Veterans, and Families Affected by Parkinson's Disease.

Overview

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.

Interventions

• Behavioral SwallowFit
  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.

Primary outcome measures

• Mann Assessment of Swallowing Ability (MASA) [Time frame: Baseline to 6 months]
• Modified Unified Parkinson Disease Rating Scale (MDS-UPDRS) [Time frame: Baseline to 6 months]
• Modified Hoehn and Yahr (HY) Scale [Time frame: Baseline to 6 months]
• Montreal Cognitive Assessment (MoCA) [Time frame: Baseline to 6 months]
• PD Quality of Life Scale (PDQ-39) [Time frame: Baseline to 6 months]

Secondary outcome measures (10)

• Modified Barium Swallowing Impairment Profile, overall impression score (MBSImp OI score) [Time frame: Baseline to 6 months]
• Spontaneous Swallowing Frequency (SSF) [Time frame: Baseline to 6 months]
• Penetration Aspiration Scale (PAS) [Time frame: Baseline to 6 months]
• Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT) [Time frame: Baseline to 6 months]
• Functional Oral Intake Scale (FOIS) [Time frame: Baseline to 6 months]
• Lingual Pressure/movement [Time frame: Baseline to 6 months]
• Sydney Swallowing Questionnaire (SSQ) [Time frame: Baseline to 6 months]
• Protocol Adherence Measure [Time frame: Baseline to 6 months]
• Patient Perception of Swallowing (VAS) [Time frame: Baseline to 6 months]
• Patient/Caregiver Acceptability/Satisfaction Scale (PA/SS) [Time frame: Baseline to 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Brooke Army Medical Center (BAMC) — San Antonio

Identifiers

NCT: NCT07356414 · STUDY00001444 · FY24 HT942524PRPIIRA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗