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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a special program can address swallowing and voice issues after Anterior Cervical Discectomy and Fusion (ACDF) surgery. The Proactive Pharyngeal-Laryngeal Exercise Program includes hydration tips, protein shakes, and daily throat and voice exercises. Participants are divided into two groups: one will try this program, while the other will use data from past patients who did not. Suitable candidates are those scheduled for ACDF surgery at NYU Langone, without spine conditions from tumors or injuries, and who have not undergone similar surgeries before. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery for future patients.

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 prior data suggests that this behavioral intervention is safe for patients undergoing ACDF surgery?

Research has shown that special throat exercises are generally safe for most people. These exercises can improve swallowing and voice function. One study found that participants who regularly performed these exercises experienced fewer issues with coughing or choking. Another report indicated that most people can do these exercises without major problems. Overall, these exercises have few side effects, making them a safe option for addressing swallowing and voice issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Proactive pharyngeal-laryngeal Exercise Program because it offers a holistic approach to addressing swallowing difficulties. Unlike traditional treatments that might focus solely on dietary modifications or surgical interventions, this program combines hydration counseling, protein supplementation, and targeted pharyngeal/laryngeal exercises. This comprehensive strategy not only aims to improve swallowing function but also supports overall nutritional health, potentially leading to better outcomes for patients.

What evidence suggests that this behavioral intervention is effective for improving swallowing difficulty after ACDF surgery?

Research shows that specific throat exercises can help people with swallowing difficulties. In this trial, participants in the Proactive Behavioral Intervention arm will receive a program including these exercises, hydration counseling, and protein supplementation to improve swallowing, especially for those with post-treatment issues like surgery. Studies suggest that similar exercises can prevent and treat swallowing problems in older adults, reducing symptoms over time. Additionally, these exercises link to better outcomes for patients undergoing treatments that might affect swallowing. Overall, the exercises have shown promising results in maintaining and improving swallowing and related functions. ^{1 2 3 6 7}

Who Is on the Research Team?

Sonja Molfenter, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10731556/

Quality of life and swallowing outcomes after early ... We hypothesized that early proactive swallowing training with TNMES or EBST alone would yield different outcomes in terms of swallowing function ...

2. pubs.asha.org pubs.asha.org/doi/10.1044/2025_PERSP-25-00093

Therapy Manuals for Clinically Implementing Proactive and ... Rationale: Maximizing pharyngeal activity during RT through exercise and eating may improve outcomes in patients who develop dysphagia symptoms

3. withpower.com withpower.com/trial/phase-dysphagia-8-2024-5afba

Behavioral Intervention for Swallowing Difficulty The results suggest that this type of exercise could be an effective strategy for preventing and treating dysphagia in older individuals, potentially reducing ...

4. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2677778

Proactive Swallowing Rehabilitation and Feeding Tube ... A proactive SLP program was associated with an increase in pretreatment SLP referral, a decrease in feeding tube placement, and improvement in the rate of ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020748920303151

Swallowing exercises for head and neck cancer patients Conclusion. Swallowing exercises demonstrated effectiveness in improving swallowing function and mouth opening in HNC patients undergoing multimodal treatment.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10178008/

Long-Term Effectiveness of Physical Exercise-Based ... Our findings suggested that regular physical exercise-based swallowing intervention effectively alleviated coughing/choking problems of older adults with ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S136883752100676X

Long-term swallowing-related outcomes in oral cancer ... Safe swallowing could be achieved in approximately 90% of the participants after six months with diet modification or compensatory maneuvers. BW at 18 and 24 ...