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Not yet recruitingNCT06328192Updated Mar 25, 2024

The Impact of Practicing Active Breathing Exercises on Elderly Individuals Living in the Community

An interventional study of Active Breathing Exercises in Dysphagia, sponsored by Copka Sonpashan. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-25.

Sponsored by Copka Sonpashan · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study summary

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

Read the detailed description

The investigators have designed a simple and user-friendly training method called "Active Breathing Exercises" based on commonly used swallowing training techniques in the department of rehabilitation medicine and the prevalent pathological causes of swallowing disorders in the elderly. The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 minutes each.

02

Conditions studied

  • Dysphagia

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03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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.

Exclusion criteria

Exclusion Criteria:

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Physical disability.
  • Difficulty in mobility.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Active Breathing Exercises

    The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Active Breathing Exercises, with weekends off and training conducted only on weekdays. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors.

    Behavioral: Active Breathing Exercises

Interventions

  • BehavioralActive Breathing Exercises

    Active breathing exercises aim to enhance the strength and flexibility of respiratory muscles through a series of exercises, improving breathing patterns and increasing respiratory efficiency. The following are common components of active breathing exercises: 1) Deep Breathing. 2) Chest Expansion. 3) Diaphragmatic Breathing. 4) Coughing Techniques. 5) Expiratory Resistance Training. 6) Gradual Increase in Activity.

05

What researchers measure

Primary outcomes

  1. Standardized Swallowing Assessment Scale

    The Standardized Swallowing Assessment Scale is a commonly used tool for evaluating swallowing function. It is widely applied in medical and rehabilitation fields to assess an individual's swallowing ability and the smooth passage of food/liquid through the esophagus. The scale ranges from 18 to 46, with lower scores indicating better swallowing function.

    Time frame: day 1 and day 21

Secondary outcomes

  1. Time consumed in eating

    The investigators require participants to eat a lunch according to their daily intake and habits, and count the time consumed

    Time frame: day 1 and day 21

  2. 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

    Time frame: day 1 and day 21

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06328192
Lead sponsor
Copka Sonpashan
Responsible party
Copka Sonpashan (The Research Director, Chao Phya Abhaibhubejhr Hospital) — Sponsor-investigator
First posted
Mar 25, 2024
Start date
Apr 2024 (estimated)
Primary completion
May 2024 (estimated)
Completion
May 2024 (estimated)
Last update
Mar 25, 2024

Study contacts

Lavie Ce
Contact
linchuangzhuce@163.com
15333828388
Nieto Luis
study director · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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