Behavioral Intervention for Swallowing Difficulty

Overseen By Sonja Molfenter, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Non-degenerative spine, Dysphagia, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment Proactive pharyngeal-laryngeal Exercise Program for swallowing difficulty?

Research shows that exercise-based therapies, like the McNeill Dysphagia Therapy Program, can improve swallowing function in people with swallowing difficulties. These programs often involve exercises that strengthen the muscles used in swallowing, which can help improve the ability to swallow safely. ^{1 2 3 4 5}

Is the exercise-based therapy for swallowing difficulty safe for humans?

Research on exercise-based therapies for swallowing difficulties, like the McNeill Dysphagia Therapy Program, has been conducted in adults and older individuals with swallowing issues. These studies focus on improving swallowing function and do not report any significant safety concerns, suggesting that such therapies are generally safe for humans. ^{1 2 4 5 6}

How is the Proactive pharyngeal-laryngeal Exercise Program different from other treatments for swallowing difficulty?

The Proactive pharyngeal-laryngeal Exercise Program is unique because it focuses on specific exercises to improve the function of the muscles involved in swallowing, unlike other treatments that may rely on dietary changes or medical devices. This program is designed to enhance the opening of the upper esophageal sphincter, which is crucial for safe swallowing, through targeted exercises. ^{2 3 6 7 8}

What is the purpose of this trial?

This study will prospectively recruit and enroll patients undergoing primary Anterior Cervical Discectomy and Fusion (ACDF) surgeries at NYU Langone. Participants will undergo pre-operative and six-week post-operative swallowing assessment using videofluoroscopy (VFSS). Acoustic voice samples and Patient Reported Outcome Measures (PROMs) for swallowing and voice will also be collected. Beginning one-week before surgery participants will begin a behavioral health program that will be continued for six-weeks after surgery. The primary goal of this study will be to determine whether a preventative behavioral health program improves instrumental measures of swallowing and voice six-weeks after ACDF surgery. .

Research Team

Sonja Molfenter, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for individuals aged 21-99 who are scheduled for primary Anterior Cervical Discectomy and Fusion (ACDF) surgery at NYU Langone. Participants must be able to consent to the study.

Inclusion Criteria

I am between 21 and 99 years old.

I am willing and able to sign the consent form for this study.

I am scheduled for ACDF surgery at NYU Langone.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Pre-operative Assessment

Participants undergo pre-operative swallowing assessment using videofluoroscopy (VFSS) and acoustic voice samples are collected

1 week

1 visit (in-person)

Behavioral Intervention

Participants begin a behavioral health program including hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise

7 weeks

Weekly virtual check-ins

Post-operative Assessment

Participants undergo six-week post-operative swallowing assessment using videofluoroscopy (VFSS) and acoustic voice samples are collected

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Proactive pharyngeal-laryngeal Exercise Program

Trial Overview The study tests if a behavioral health program, including exercises for throat muscles, hydration advice, and protein supplements, can improve swallowing and voice after ACDF surgery. It involves assessments before and six weeks post-surgery.

Participant Groups

Group I: Proactive Behavioral Intervention coupled with protein supplementation Experimental Treatment 3 Interventions

Patients will receive the behavioral intervention program comprised of hydration counseling, protein supplementation, and daily pharyngeal/laryngeal exercise for a total of 7 weeks.

Group II: Historical Control Group Active Control 1 Intervention

Historical control data from subjects who underwent Anterior Cervical Discectomy and Fusion (ACDF) surgery but did not receive any behavioral intervention.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

An 8-week exercise-based swallowing intervention significantly improved swallowing physiology in nine healthy older adults with dysphagia, as shown by enhanced scores on the Modified Barium Swallowing Impairment Profile (MBSImP).

Key improvements included better initiation of the pharyngeal swallow, laryngeal elevation, and reduced pharyngeal residue, indicating that targeted swallowing exercises can effectively enhance swallowing function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An intensive swallowing exercise protocol for improving swallowing physiology in older adults with radiographically confirmed dysphagia. Balou, M., Herzberg, EG., Kamelhar, D., et al.[2022]

Resistance training of swallowing muscles in older individuals with dysphagia did not lead to significant improvements in swallowing function, as measured by the Eating Assessment Tool (EAT-10) scores, in a study involving 91 participants.

The study found that better nutritional status was independently correlated with improved swallowing function, suggesting that addressing nutrition may be more beneficial than resistance training alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of resistance training of swallowing muscles on dysphagia in older people: A cluster, randomized, controlled trial. Wakabayashi, H., Matsushima, M., Momosaki, R., et al.[2019]

An 8-week progressive lingual resistance exercise program significantly improved swallowing pressures and increased lingual volume by an average of 5.1% in older adults aged 70 to 89, indicating enhanced swallowing function.

The results suggest that this type of exercise could be an effective strategy for preventing and treating dysphagia in older individuals, potentially reducing related health issues like pneumonia and malnutrition while improving overall quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of lingual exercise on swallowing in older adults. Robbins, J., Gangnon, RE., Theis, SM., et al.[2022]

In a study involving 45 head and neck cancer patients, adherence to a preventive swallowing exercise program was high, with a median adherence rate of 78%, although it fell slightly below the 80% threshold considered optimal.

No significant associations were found between adherence to the exercise program and factors such as HPV status, partner status, chemotherapy, or tumor site, suggesting that these factors may not influence patients' commitment to the exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. Hajdú, SF., Christensen, MB., Kristensen, MØ., et al.[2019]

The study emphasizes the need for a collaborative approach between dietitians and speech therapists to improve swallowing training for elderly patients with oropharyngeal dysphagia in long-term care facilities.

By implementing a structured care model that includes specific protocols for swallowing training and dietary adjustments, the study aims to enhance the effectiveness of interventions, ultimately improving the quality of life for patients and meeting the expectations of their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Interprofessional Collaborative Practice in Long-Term Care: Swallow Training]. Liang, FC., Cho, MH.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Functional and physiological outcomes from an exercise-based dysphagia therapy: a pilot investigation of the McNeill Dysphagia Therapy Program. [2015]

2. New Zealand pubmed.ncbi.nlm.nih.gov

An intensive swallowing exercise protocol for improving swallowing physiology in older adults with radiographically confirmed dysphagia. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Behavioral Interventions Targeting Insufficient Upper Esophageal Sphincter Opening During Swallowing: A Scoping Review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effects of resistance training of swallowing muscles on dysphagia in older people: A cluster, randomized, controlled trial. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Normalization of temporal aspects of swallowing physiology after the McNeill dysphagia therapy program. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

The effects of lingual exercise on swallowing in older adults. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adherence to preventive swallowing exercises for head and neck cancer patients undergoing (chemo)radiotherapy treatment. [2019]

8. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

[Interprofessional Collaborative Practice in Long-Term Care: Swallow Training]. [2022]