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A feasibility study for a multifactorial Intervention in outpatients with frailty (pilot study)

Development of a multifactorial program for frail older adults: a feasibility study - Development of a multifactorial program for frail older adults: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000047109
Enrollment
30
Registered
2022-03-08
Start date
2022-03-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Frailty

Interventions

Multifactorial intervention composed of exercise, nutrition, oral health, and social interaction programs Exercise program Multifactorial exercise program (once a week, 60 min/session) + exercise

Sponsors

Tokyo Metropolitan Institute of Gerontology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Men and women aged 65 and older 2) Outpatients with frailty 3) Those who fall under the pre-frailty (4 - 7 points) or frailty (8 points or more) categories on the basic checklist 4) Smartphone users

Exclusion criteria

Exclusion criteria: Persons: 1) who have been diagnosed with dementia or prescribed anti-dementia medications 2) who have a disability affecting basic activities of daily living 3) who are prohibited from exercising (except for light exercise) by their family physician 4) who are on restricted protein diets for disease management and those with eGFR below 30 5) who have had angina, severe heart failure, terminal illness, myocardial infarction or cardiac surgery, or have been in palliative care within the past three months 6) who need to change their medications at the time of enrollment 7) who are participating in a specific rehabilitation program 8) who cannot walk more than 10 meters without assistance 9) who suffered a femoral neck fracture in the past 10) participating in other clinical research, and those participating-or who plan to participate-in a clinical trial 11) who have difficulty communicating in Japanese 12) who are deemed ineligible to be research participants at the discretion of the principal investigator and physician (co-investigator) 13) whose informed consent cannot be obtained

Design outcomes

Primary

MeasureTime frame
Rate of participation in the program

Secondary

MeasureTime frame
Frailty phenotype Revised J-CHS Motor function Short Physical Performance Battery Cognitive function 1) MMSE-J 2) Word fluency 3) Logical Memory 1, 2 4) Digit Symbol Substitution Test 5) Trail Making Test Part A, B 6) Digit Span Test 7) Composite score calculated from MMSE, DSST, TMT, logical memory, number counting, and word recall tests 8) DASC-21 Nutrition and oral function 1) Dietary variety score 2) Council on Nutrition Appetite Questionnaire-J 3) Oral function Body composition Percent fat mass and fat-free mass measured by InBody770 Blood test WBC, RBC, PLT, Hb, Ht, MCV, MCH, MCHC, differential count of leukocytes, TP, ALB, A/G, CRP, T-Bil, AST, ALT, LDH, gamma-GTP, CK, BUN, CRE, eGFR-CRE, UA, NA, K, Cl, TG, T-Chol, LDL-Chol, HDL-Chol, BG, Ft, Zn, HbA1c, GA, cystatin c, F-T3, F-T4, TSH Urine analysis Qualitative urine analysis, urinary sediment analysis, urinary microalbumin, U-CRE, U-Na, U-Cl, U-K Mental Health 1) S-WHO-5-J 2) Japanese version of the UCLA Loneliness Scale 3) Subjective well-being Social function and functional capacity 1) TMIG-IC 2) JST-IC 3) Japanese version of the Lubben Social Network Scale (LSNS-6) 4) Frequency of social interaction 5) Frequency of going out 6) Frequency of social participation 7) Smartphone use 8) Use of social networking services (SNS) 9) Willingness to continue using SNS 10) SNS use during the course Impression of the programs/satisfaction level Safety Incidences of diseases or disorders developed during the intervention period will be checked. Adherence Withdrawal/dropout rates Reasons for dropout The reasons for dropouts, such as relocation, hospitalization, poor health, or busy schedule, will be clarified.

Countries

Japan

Contacts

Public ContactKeiko Motokawa

Tokyo Metropolitan Institute of Gerontology Research Team for Promoting Independence and Mental Health

kmoto@tmig.or.jp03-3964-1141

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026