SwallowFIT for Parkinson's Disease

GC
Overseen ByGiselle Carnaby, PhD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special swallow exercise can improve swallowing ability in people with Parkinson's disease. It compares participants performing the exercise, called SwallowFit, to those receiving usual care. The SwallowFit group will train twice a week for six weeks to enhance their swallowing fitness. Suitable candidates have Parkinson's with some swallowing concerns but can still eat by mouth and walk unaided. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance the quality of life for those with Parkinson's.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you must not have changed your medication for at least 4 weeks before joining the study.

What prior data suggests that this swallow exercise is safe for patients with Parkinson's disease?

Research shows that SwallowFit, a program of swallowing exercises, is under study to determine its safety and effectiveness in helping people with Parkinson's disease improve their swallowing. Although detailed safety information specifically for SwallowFit is limited, these types of exercises are generally considered safe.

Swallowing exercises are non-invasive, meaning they don't involve surgery or medication, and they focus on strengthening the muscles used for swallowing. This typically results in fewer risks compared to treatments involving drugs or surgery. Studies on similar exercises suggest they are safe, with no major negative effects reported.

While the trial's phase is unspecified, testing on people indicates that earlier research deemed it safe enough to proceed. Additionally, because the trial does not involve drugs, the risk of serious side effects is lower. Participants in the SwallowFit group will receive training and feedback to help improve their swallowing, a common component of physical rehabilitation.12345

Why are researchers excited about this trial?

Researchers are excited about SwallowFit for Parkinson's disease because it introduces a unique approach to improving swallowing function, which is often impacted in this condition. Unlike traditional methods where treatment is only provided if a clear problem is identified, SwallowFit proactively trains patients using a six-week program that includes specific swallowing exercises. Using surface electromyographic (sEMG) biofeedback, it helps guide and improve swallowing movements, effort, and performance. This innovative technique is designed to stimulate and enhance the strength and coordination of swallowing through progressive resistance exercises, offering a potentially more effective and engaging way to address swallowing difficulties in Parkinson's patients.

What evidence suggests that the SwallowFIT exercise is effective for improving swallowing fitness in Parkinson's disease?

Research shows that swallowing exercises can help people with Parkinson's disease improve their ability to swallow. In this trial, participants may be randomized to receive the SwallowFIT intervention, a program with special exercises to strengthen the muscles used for swallowing. These exercises use biofeedback, providing real-time information on muscle activity to guide better swallowing movements. Previous studies have found that similar exercises can improve swallowing. While detailed data on SwallowFIT is still being gathered, the method appears promising because it directly addresses swallowing problems common in Parkinson's.12345

Who Is on the Research Team?

GC

Giselle Carnaby, PhD, MP

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease who are interested in improving their swallowing ability. Participants will engage in a proactive swallow exercise program over 6 weeks, with sessions twice a week.

Inclusion Criteria

I have been diagnosed with Parkinson's Disease, mainly showing tremors or stiffness.
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)
See 4 more

Exclusion Criteria

History of other neurological disease potentially causing dysphagia
Dementia (MMSE<20; Montreal cognitive assessment (MoCA) ≤ 20)
I am experiencing severe depression.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 weeks of twice-weekly SwallowFIT training, each session lasting one hour

6 weeks
12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

  • SwallowFit

Trial Overview

The SwallowFIT study tests if special swallow exercises can improve swallowing fitness in Parkinson’s patients compared to those receiving standard treatment. The effectiveness of the exercises will be measured from start to end of the study.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: SwallowFit InterventionExperimental Treatment1 Intervention
Group II: Clinical Monitoring Only (CMO)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

United States Department of Defense

Collaborator

Trials
940
Recruited
339,000+

Citations

SwallowFIT for Parkinson's Disease · Info for Participants

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New $1.9M DoD-Funded Trial Aims to Improve Swallowing ...

New $1.9M DoD-Funded Trial Aims to Improve Swallowing in Early Parkinson's Patients. Swallowing problems, or dysphagia, affect up to 80% of ...