The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents

The Impact of Diaphragm Training on Dysphagia in Elderly Nursing Home Residents: A Preliminary Study

The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysphagia
• Intervention / Treatment: Behavioral: Diaphragm Training

Detailed Description

Diaphragm training for dysphagia in elderly nursing home residents involves exercises and techniques aimed at strengthening the diaphragm muscle to improve swallowing function. Dysphagia, or difficulty swallowing, is common among older adults and can lead to complications such as malnutrition, dehydration, and aspiration pneumonia. Diaphragm training may include breathing exercises, postural adjustments, and swallowing maneuvers designed to enhance coordination and strength in the muscles involved in the swallowing process. By targeting the diaphragm, which plays a crucial role in breathing and swallowing coordination, this training approach aims to alleviate dysphagia symptoms and improve overall swallowing function in elderly nursing home residents, thus enhancing their quality of life and reducing the risk of associated health complications.

The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laviena Ce; Phone Number: 15422548954; Email: byyx0517@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age over 60 years old.
• No hospitalization within the past six months.
• With clear consciousness and able to cooperate with questionnaires and training.
• The elderly people who voluntarily participate and agree to adhere until the end of the study.
• early dysphagia caused by sarcopenia.

Exclusion Criteria:

• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Physical disability.
• Difficulty in mobility.
• Simultaneously receiving other therapies that might influence this study.
• Individuals with a gastrostomy.
• Abnormalities of the oral, pharyngeal, or esophageal structures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: the intervention group; Diaphragm Training will be given twice a day and 30min per time.	Behavioral: Diaphragm Training; Diaphragm training includes both active and passive methods. Passive training involves placing weights on the participant's abdomen to provide resistance during breathing. Active training involves instructing participants to practice diaphragmatic breathing techniques.
No Intervention: the blank group; No intervention will be applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gugging Swallowing Screen	The Gugging Swallowing Screen is used to assess dysphagia. The Screen consists of 10 items covering various aspects of swallowing, including oral and pharyngeal muscle function, oral sensation, tongue coordination, and more. The total scores range from 1 to 20, with lower scores indicating more severe dysphagia.	day 1 and day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time consumed in eating	We require participants to eat a lunch according to their daily intake and habits, and count the time consumed	day 1 and day 21
Swallowing-Related Quality of Life Questionnaire	The Swallowing-Related Quality of Life Questionnaire (SWAL-QOL) is a validated tool used to assess the impact of swallowing difficulties on quality of life. It is a 44-item questionnaire designed to measure the physical, emotional, and social domains of swallowing-related quality of life.The higher final scores indicate the better life quality. The total score will be converted into a standard percentage	day 1 and day 21
Eating Assessment Tool-10	Subjective perception of swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10). The EAT-10 comprises 10 questions that assess various aspects of swallowing function. Each question is scored on a scale from 0 to 4, indicating the severity of swallowing difficulty, with 0 for no difficulty and 4 for severe difficulty. Participants could rate it based on the subjective perception. The total score on the EAT-10 ranges from 0 to 40, with higher scores indicating more severe swallowing disorders.	day 1 and day 21
Dysphagia Handicap Index	Dysphagia Handicap Index is a self-reported questionnaire used to assess the impact of dysphagia on an individual's quality of life. It typically consists of multiple questions related to the physical, functional, and emotional aspects of swallowing difficulties. The total score range varies between 0 and 100. A higher score indicates a greater perceived impact of dysphagia on the individual's quality of life.	day 1 and day 21

Collaborators and Investigators

• Sponsor: Copka Sonpashan
• Investigators: Study Chair: Louis Wi, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 27, 2024
• First Submitted That Met QC Criteria: April 27, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 27, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: GejiYanglaoyuan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No