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SwallowFIT Study in Parkinson's Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
35 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 12 visits

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Completion of the program will include 12 visits."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether SwallowFIT exercises help people with Parkinson’s disease swallow better than usual care. The exercise group will have one-hour training sessions twice a week for 6 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 35 and up to 90 years old.
  • Have or may have idiopathic Parkinson’s disease, which means its cause is unknown.
  • Have Parkinson’s disease at stage II or III on the Hoehn and Yahr scale, based on the latest nerve and brain exam.
  • Have a swallowing concern shown by a swallowing score above 0 on the MDS-UPDRS or a MASA score of 185 or lower.
  • Can eat or drink by mouth, with a Functional Oral Intake Score of 6 or lower.
  • Can walk.
  • Have had no medicine changes for at least 4 weeks before joining.

Who can't join

  • Have stage IV Parkinson’s disease, cannot follow two-step directions, or have another nerve or brain disease that could cause trouble swallowing.
  • Have dementia with an MMSE score below 20 or MoCA score of 20 or lower, or severe depression with a BDI score above 19.
  • Have severe uncontrolled head and neck movements that interfere with recording the swallowing X-ray test.
  • Have a severe, documented digestive disease, or have had surgery on the stomach or the tube that carries food to it.
  • Have had head or neck cancer that affected swallowing or required surgery.
  • Have a history of breathing disease needing breathing support, untreated high blood pressure, or heart disease needing activity limits and medical care.
  • Have received speech therapy for swallowing in the past 3 months.
  • Are pregnant, breastfeeding, or planning to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

TX