Swallowing Exercises + Protein for Older Adults

(PE(PP) Trial)

Recruiting at 1 trial location

Overseen By Maria Travino Sampler

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Dysphagia, Chronic kidney disease, MRI contraindications

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether swallowing exercises, with or without protein drinks, can strengthen swallowing muscles in older adults. Weak swallowing muscles can cause problems like difficulty eating, malnutrition, and frailty. Participants will first undergo a 12-week period of normal activity, then perform swallowing exercises (also known as pharyngeal exercises) with or without protein supplements for another 12 weeks. Those aged 65 or older who find walking or climbing stairs challenging might be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to understanding how lifestyle changes can improve health in older adults.

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 trial coordinators.

What prior data suggests that these swallowing exercises and protein supplementation are safe for older adults?

Research has shown that swallowing exercises are generally safe and helpful for older adults. One study found that these exercises improved swallowing, which is crucial for those experiencing difficulty. Another study found that these exercises reduced issues like coughing and choking, common in older adults with swallowing problems. This suggests that the exercises are well-tolerated.

When combined with protein supplements, these exercises remain safe for older adults. Protein can help strengthen muscles, potentially increasing the benefits of the exercises. Research indicates that this combination effectively reduces the severity of swallowing problems in older adults with dysphagia (difficulty swallowing).

Overall, both the exercises and their combination with protein are considered safe and beneficial for improving swallowing function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the combination of swallowing exercises and protein supplementation for older adults because it targets the root of swallowing difficulties in a novel way. Unlike typical treatments that might focus solely on exercises or dietary changes, this approach combines targeted pharyngeal exercises with protein supplementation, potentially enhancing muscle strength and function in the throat more effectively. This dual approach could lead to improved outcomes by not only maintaining but also potentially improving swallowing ability, which is crucial for overall health and quality of life in older adults.

What evidence suggests that this trial's treatments could be effective for improving swallowing in older adults?

Research has shown that swallowing exercises can help older adults improve their swallowing ability. Studies have found that these exercises can reduce swallowing difficulties and enhance overall skills. In this trial, participants will be randomized to receive either swallowing exercises alone or combined with protein supplements. Combining these exercises with protein supplements may further strengthen the muscles used for swallowing. This combined approach has shown promise in healthy older adults, possibly leading to better swallowing and improved health. Evidence suggests that both swallowing exercises alone and with protein supplements can benefit older adults with swallowing difficulties. ^{1 2 4 6 7}

Who Is on the Research Team?

Sonja Molfenter

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for older adults who have some level of frailty or difficulty with physical activities like walking, standing up from a chair, climbing stairs, or are at risk of falls. They must be 65 years or older and mentally sharp enough to follow the study's procedures (scored by MoCA). People with swallowing issues due to structural/neurological reasons, severe kidney disease, or those unable to undergo MRI scans cannot participate.

Inclusion Criteria

Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA)

I am 65 years old or older.

I am either somewhat frail or need help with physical activities.

Exclusion Criteria

Contraindications to 3T whole body MRI scanners (e.g., pacemaker, cerebral aneurysm clip, cochlear implant, presence of shrapnel in strategic locations, metal in the eye, claustrophobia, or other problems)

I cannot eat a lot of protein due to advanced kidney disease.

I have a physical or nerve problem causing difficulty swallowing.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Participants engage in 'usual activity' for 12 weeks to serve as their own control

12 weeks

Treatment

Participants are randomized to 12 weeks of swallowing exercises with or without protein supplementation

12 weeks

Follow-up

Participants are monitored for changes in muscle thickness and physical performance

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pharyngeal Exercise
• Protein

Trial Overview The study tests if doing swallowing exercises for 12 weeks can strengthen the muscles involved in swallowing among seniors. It also looks at whether adding daily protein drinks enhances these benefits. Participants will first observe their normal routine without interventions and then be randomly assigned to either just do exercises or do them along with taking protein supplements.

How Is the Trial Designed?

Group I: Control, then Swallowing Exercises + Protein Experimental Treatment 3 Interventions

Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of "usual activity."

Group II: Control, then Swallowing Exercises Active Control 2 Interventions

Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of "usual activity."

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

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]

In a clinical trial with 19 patients suffering from oropharyngeal dysphagia, the Shaker exercise led to significantly less aspiration compared to traditional swallowing therapy after 6 weeks of treatment.

Both the Shaker exercise and traditional therapy improved swallowing physiology, as indicated by increased hyoid and laryngeal movements, and both therapies enhanced upper esophageal sphincter (UES) opening width during swallowing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. Logemann, JA., Rademaker, A., Pauloski, BR., et al.[2022]

Dysphagia rehabilitation significantly improves the likelihood of achieving total oral intake at discharge for older adults with aspiration pneumonia, with an odds ratio of 1.32, based on a study of 98,374 patients.

The benefits of dysphagia rehabilitation are more pronounced in patients with mild pneumonia compared to those with moderate or severe pneumonia, and early rehabilitation is associated with better outcomes than late rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dysphagia rehabilitation on oral intake in elderly patients with aspiration pneumonia. Momosaki, R., Yasunaga, H., Matsui, H., et al.[2015]

Isometric lingual strength training has shown positive effects on increasing maximum peak lingual pressures in both healthy adults and some individuals with dysphagia, suggesting it may help improve swallowing function.

However, the variability in study designs makes it difficult to determine if these strength gains translate into actual improvements in swallowing function, indicating a need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. McKenna, VS., Zhang, B., Haines, MB., et al.[2022]

A novel resistance exercise program called Swallowing Against Laryngeal Restriction (SALR) significantly improved key swallowing mechanics in healthy elderly participants, including increased upper esophageal sphincter opening and laryngeal movement after 6 weeks of training.

In contrast, a sham exercise did not produce any significant changes, highlighting the efficacy of the SALR program in enhancing the pharyngeal phase of swallowing, which could lead to better swallow health maintenance in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. Agrawal, D., Kern, M., Edeani, F., et al.[2019]

Oropharyngeal exercises can significantly improve swallowing functions in healthy older adults, enhancing muscle strength and endurance related to swallowing, as shown in 22 out of 23 reviewed studies.

Despite the positive effects on swallowing mechanics, the overall impact on swallowing efficiency and safety is still uncertain, highlighting the need for further research to explore long-term benefits and prevent dysphagia in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of oropharyngeal exercises on the swallowing mechanism of older adults: A systematic review. Chua, DMN., Choi, YY., Chan, KM.[2023]

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]

Exercise is increasingly recognized as a beneficial intervention in geriatric medicine, particularly for improving swallowing function and reducing fall risk in older adults with dysphagia.

Current research emphasizes the need for evidence-based studies to explore how exercise can promote neural plasticity, potentially leading to lasting improvements in swallowing abilities among the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of sensorimotor exercise on swallowing outcomes relative to age and age-related disease. Kays, S., Robbins, J.[2022]

Game-based chin-tuck against resistance exercise is as effective as traditional head-lift exercise in improving swallowing function for stroke patients with dysphagia, based on evaluations using the videofluoroscopic dysphagia scale and penetration-aspiration scale.

Patients found the game-based exercise more enjoyable and less physically demanding, leading to higher motivation and lower muscle fatigue compared to the traditional exercise, suggesting it may enhance compliance in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of game-based chin tuck against resistance exercise vs head-lift exercise in patients with dysphagia after stroke: An assessor-blind, randomized controlled trial. Park, JS., Lee, G., Jung, YJ.[2020]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979051/

Efficacy of swallowing rehabilitative therapies for adults with ... The current NMA findings demonstrate the superior efficacy of combining CTAR and Shaker exercises with traditional dysphagia therapy (TDT), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07049471

The Effect of Swallowing Exercise and Maneuver Program ... This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and ...

3. brieflands.com brieflands.com/articles/mejrh-130196

Effects of Rehabilitative Exercises on Swallowing Function ... Conclusions: Our research has indicated that swallowing rehabilitative exercises are more effective in improving clinical swallowing function in elderly persons ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40579919/

Effectiveness of swallowing rehabilitation exercises in ... Swallowing rehabilitation exercises play a crucial role in improving swallowing function in older adults with dysphagia by reducing dysphagia severity.

5. jnursrcp.com jnursrcp.com/article_197142.html

Effects of various oral exercises on swallowing function in ... A study in South Korea by Oh, (2021) measured the effect of effortful swallowing exercise on swallowing function in older adults.

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. asha.org asha.org/practice-portal/clinical-topics/adult-dysphagia/?srsltid=AfmBOooflm3tJTI4ko1eCjRQ6KVuPofMyqJS9FOyqQV8o7QaTqblIjOs

Adult Dysphagia Dysphagia intervention may concentrate on swallowing exercises, compensatory swallowing strategies (including posture considerations), bolus consistency ...