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

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 trial coordinators.

What data supports the effectiveness of the treatment Swallowing Exercises + Protein for Older Adults?

Research shows that swallowing exercises, like the Shaker exercise and resistance training, can improve swallowing function and reduce aspiration (inhaling food or liquid into the airway) in older adults with dysphagia (difficulty swallowing). These exercises help strengthen the muscles involved in swallowing, leading to better oral intake and swallowing physiology. ^{1 2 3 4 5}

Is it safe for older adults to do swallowing exercises?

Swallowing exercises, like those for strengthening muscles, are generally considered safe for older adults and can help maintain swallowing function as they age. ^{4 6 7 8 9}

How is the treatment of swallowing exercises and protein for older adults different from other treatments for swallowing difficulties?

This treatment is unique because it combines swallowing exercises, which strengthen the muscles involved in swallowing, with protein intake to potentially enhance muscle recovery and growth. Unlike other treatments that may focus solely on exercises or dietary changes, this approach targets both muscle strengthening and nutrition to improve swallowing function in older adults. ^{5 6 7 9 10}

What is the purpose of this trial?

The swallowing muscles are prone to decreased strength and function as part of the natural aging process which can lead to difficulty swallowing, malnutrition, and frailty. Exercise and nutrition are powerful stimulators of muscular change. The proposed research will investigate the effectiveness of a 12-week proactive regimen of swallowing exercises (with or without daily protein supplement drinks) to improve the composition, force, and physiology of the swallowing muscles and explore the relationship to overall health and physical function in 80 community-dwelling older adults. Each participant will serve as their own control for 12 weeks before being randomized to complete swallowing exercises alone or swallowing exercises with protein drinks.

Research Team

Sonja Molfenter

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

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

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

A randomized study comparing the Shaker exercise with traditional therapy: a preliminary study. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

Effect of dysphagia rehabilitation on oral intake in elderly patients with aspiration pneumonia. [2015]

4. Sweden 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. [2020]

5. 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]

6. England pubmed.ncbi.nlm.nih.gov

Swallow strength training exercise for elderly: A health maintenance need. [2019]

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

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

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

Effects of sensorimotor exercise on swallowing outcomes relative to age and age-related disease. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Effects of oropharyngeal exercises on the swallowing mechanism of older adults: A systematic review. [2023]

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

A Systematic Review of Isometric Lingual Strength-Training Programs in Adults With and Without Dysphagia. [2022]