Examination of the effect of improving oral function on physical and mental frailty

JRCT ID: jRCT1062210063

Registered date:17/12/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: frailty
• Date of first enrollment: 17/12/2021
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Perform oral exercises in the specified manner and at the specified frequency for 3 months.

Outcome(s)

• Primary Outcome: frailty (Japanese version of Cardiovascular Health Study index)

Secondary Outcome

Sarcopenia (musculoskeletal muscle mass)
Nutritional status (mini nutritional status assessment)
Oral function (number of bacteria on tongue, oral wetness, bite strength, tongue pressure, masticatory function, tongue/lip movement function, swallowing function)
Number of teeth: number of teeth present, number of functional teeth
Periodontal status: periodontal pocket depth, bleeding during probing
Mental/psychological status (Geriatric Depression Rating Scale)
Social frailty index (Makizako's index)

Key inclusion & exclusion criteria

• Age minimum: >= 60age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Patients who meet all of the following criteria are eligible
1) Age of 60 years or older at the time of obtaining consent
2) Patients who have no experience in performing oral exercises.
3) Outpatients of the Department of Dentistry and Preventive Dentistry, Okayama University Hospital.
4) Patients who have received sufficient explanations about participation in this study and have given written consent of their own free will with full understanding.

Exclude criteria

Patients who violate any of the following will not be included in this study
1) Patients who are unable to walk independently
2) Patients who are unable to respond to the questionnaire survey.
3) Other patients who are judged inappropriate as research subjects by the principal investigators and sub-investigators.

Related Information

• Primary Sponsor: Manabu Morita
• Source(s) of Monetary Support: Japan Society for the Promotion of Science