UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051628 |
|---|---|
| Receipt number | R000058910 |
| Scientific Title | Investigation of the relationship between physical function and physical activity and feeding and swallowing function |
| Date of disclosure of the study information | 2023/07/18 |
| Last modified on | 2023/07/18 07:03:01 |
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Basic information
Public title
Investigation of the relationship between physical function and physical activity and feeding and swallowing function
Acronym
Investigation of the relationship between physical function and physical activity and feeding and swallowing function
Scientific Title
Investigation of the relationship between physical function and physical activity and feeding and swallowing function
Scientific Title:Acronym
Investigation of the relationship between physical function and physical activity and feeding and swallowing function
Region
| Japan |
Condition
Condition
Frail elderly subjects
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between physical function and physical activity and feeding and swallowing function in order to prevent aspiration pneumonia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Eating and swallowing function is estimated with the Repeated Saliva Swallowing Test (RSST), the Revised Water Swallowing Test (MWST), and tongue pressure muscle strength.Body measurements and body composition will be estimated by body weight, body mass index (BMI), body fat percentage, body fat mass, skeletal muscle mass, upper arm circumference (AC), triceps subcutaneous fat thickness (TSF), upper arm muscle circumference (AMC), upper arm muscle area (AMA), and lower leg circumference (CC). Physical performance is estimated by grip strength, maximum walking speed, number of repetitive openings and closings of the lower extremities, quadriceps endurance, lower extremity muscle strength, respiratory muscle function (peak flow meter), and functional independence measures (FIM).
Key secondary outcomes
Cognitive function is estimated with the Mini-Mental State Examination (MMSE) and NM scale.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Participants whose consent was obtained that did not meet the exclusion criteria
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The residents are 65 years of age or older (Category 1 insured persons) and meet the admission criteria of the long-term care insurance system, requiring 1 to 5 levels of nursing care, and live under medical supervision by a physician, receiving not only nursing and nursing care but also rehabilitation by occupational therapists and physical therapists, as well as nutritional management and meals by a dietitian. The residents of a geriatric health care facility who are living in a geriatric health care facility under the care of a doctor, occupational therapists, physiotherapists, etc.
Key exclusion criteria
Those in need of enteral or intravenous nutritional therapy. Patients with severe dysphagia who are unable to take food orally. Those with a level of consciousness rating (JCS: Japan coma scale) of 2-2 or higher. Patients who frequently fall ill. Persons who are incapable of understanding the research explanation (However, if the consent of a substitute is obtained, the participant will be included in the study, but if signs or actions of refusal are observed from the participant himself/herself, participation in the study will be terminated immediately.). Persons who are determined not to be included as participants by the judgment of the facility director, who is the facility physician.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Department of Food and Nutrition, Faculty of Contemporary Human Life Science
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
TEL
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Abe |
Organization
Tezukayama University
Division name
Department of Food and Nutrition, Faculty of Contemporary Human Life Science
Zip code
631-8585
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
TEL
0742-41-4742
Homepage URL
sa-abe@tezukayama-u.ac.jp
Sponsor or person
Institute
Tezukayama University
Institute
Department
Personal name
Funding Source
Organization
Tezukayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tezukayama University
Address
3-1-3 Gakuenminami, nara-shi, nara-ken, Japan
Tel
0742-41-4742
sa-abe@tezukayama-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
05-14
Org. issuing International ID_1
Tezukayama University Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 18 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058910
