NCT06328257

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

3 months

First QC Date

March 10, 2024

Last Update Submit

March 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Time consumed in eating

    day 1 and day 21

  • Functional Oral Intake Scale

    day 1 and day 21

Study Arms (1)

Myofascial Release Training

EXPERIMENTAL

The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Myofascial Release Training, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-30 minutes. Each training session will be conducted approximately one hour prior to meals. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors

Behavioral: Myofascial Release Training

Interventions

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. Myofascial release therapy is commonly used to treat muscle spasms, chronic pain, skeletal and joint issues, among others.

Myofascial Release Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Dysphagia

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Nieto Luis

    Site Coordinator of United Medical Group

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
The Research Director

Study Record Dates

First Submitted

March 10, 2024

First Posted

March 25, 2024

Study Start

May 1, 2024

Primary Completion

August 1, 2024

Study Completion

August 1, 2024

Last Updated

March 25, 2024

Record last verified: 2024-03