Pharyngeal Exercise (Plus Protein)

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Single-center Randomized Clinical Trial to Test the Efficacy of Pharyngeal Swallowing Exercises (With or Without Protein Supplementation) to Build Pharyngeal Muscular Reserve in Pre-frail Older Adults

Conditions
-----------------
Pre-Frail Older Adults

Intervention / Treatment
-----------------
* Behavioral: Pharyngeal Swallowing Exercises
* Dietary Supplement: Protein Supplementation
* Device: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be 65 years of age or older. Participants must score a 1 or 2 on the FRAIL scale OR a 4 or greater on the Strength, Assistance in Walking, Rise from a Chair, Climb Stairs and Falls (SARC-F) Questionnaire. Participants must score 26 or greater on the Montreal Cognitive Assessment (MoCA). Willingness to participate in the study procedures. Exclusion Criteria: Known structural or neurological causes of dysphagia. Cannot consume high levels of protein (Chronic Kidney Disease Stage 3 or higher). 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).

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control, then Swallowing Exercises + Protein<br>Participants randomized to 12 weeks of swallowing exercises with protein supplementation, after completing an initial 12-week period of usual activity. | Behavioral: Pharyngeal Swallowing Exercises<br>* 12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds.<br>Dietary Supplement: Protein Supplementation<br>* 12-week supply of the commercially-available Premier Protein Clear ® High Protein (20 grams of protein and 90 calories per 16.9 oz. drink). Participants will be asked to consume one drink per day for the 12-week intervention period.<br>Device: MRI<br>* Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.<br>|
| Active Comparator: Control, then Swallowing Exercises<br>Participants randomized to 12 weeks of swallowing exercises without protein supplementation, after completing an initial 12-week period of usual activity. | Behavioral: Pharyngeal Swallowing Exercises<br>* 12-weeks of proactive pharyngeal swallowing exercises conducted 5 times per week. The exercise program will include the following four exercises: effortful saliva swallows, tongue-hold swallows, effortful pitch glides and posterior lingual resistance. Each exercise set will include 10 repetitions of each exercise (40 reps per set). The number of sets will be gradually increased as tolerance builds.<br>Device: MRI<br>* Participants will be scanned using a 3T MRI scanner and a 16-channel phased array neck coil.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Thickness of the Superior Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle. | Baseline, Week 13 | 
| Change in Thickness of the Superior Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the superior pharyngeal constrictor muscle. | Baseline, Week 28 | 
| Change in Thickness of the Middle Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle. | Baseline, Week 13 | 
| Change in Thickness of the Middle Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the middle pharyngeal constrictor muscle. | Baseline, Week 28 | 
| Change in Thickness of the Inferior Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle. | Baseline, Week 13 | 
| Change in Thickness of the Inferior Pharyngeal Constrictor Muscle | Axial T2-weighted images through the C1 level, hyoid bone and arytenoid cartilages will be used to measure the thickness of the inferior pharyngeal constrictor muscle. | Baseline, Week 28 | 
| Change in Maximum Pharyngeal Constriction During Swallowing | Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy. | Baseline, Week 13 | 
| Change in Maximum Pharyngeal Constriction During Swallowing | Maximum pharyngeal constriction area (normalized to spine length) will be captured at the height of the swallow on videofluoroscopy. | Baseline, Week 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Short Physical Performance Battery (SPPB) Scores | The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome). The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability. | Baseline, Week 13 | 
| Change in Short Physical Performance Battery (SPPB) Scores | The SPPB comprises a gait speed test, a chair stand test, and three balance tests. The gait speed test score ranges from 0 (worst outcome) to 4 (best outcome); the chair stand test score ranges from 0 (worst outcome) to 4 (best outcome); the side-by-side stand test score ranges from 1 (best outcome) to 0 (worst outcome); the semi-tandem stand test score ranges from 1 (best outcome) to 0 (worst outcome); and the tandem stand test scores range from 2 (best outcome) to 0 (worst outcome). The total SPPB score is the sum of the test scores and ranges from 0-12, with lower scores indicating greater disability. | Baseline, Week 28 | 
| Change in Fat-Free Muscle Index | Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer. | Baseline, Week 13 | 
| Change in Fat-Free Muscle Index | Fat-free muscle index measured via bioelectrical impedance analysis using the InBody 570 multi-frequency analyzer. | Baseline, Week 28 | 
| Change in Pre-Albumin Levels | Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples. | Baseline, Week 13 | 
| Change in Pre-Albumin Levels | Levels of pre-albumin, a marked of undernutrition, will be measured using patient blood samples. | Baseline, Week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proactive exercise, protein, nutrition