An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2 diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled trial

An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2 diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled trial - An evaluation of the effectiveness of a multi-disciplinary intervention in older type 2 diabetes patients with pre-frailty or frailty : study protocol for a randomized controlled trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000022968

Enrollment

180

Registered

2016-07-04

Start date

2016-04-01

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

Type 2 diabetes mellitus

Interventions

Participants receive the monthly core curriculum for 3 months. The core curriculum consists of 3 components: lecture on self-management, individual nutrition counseling and exercise training.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The subject fulfils the OSHPE's criteria for frailty or pre-frailty.

Exclusion criteria

Exclusion criteria: Mini Mental State Examination (MMSE) score less than 18 points Cancer bearing Terminal illness (life expectancy <12 months) Severe diabetes microvascular complications (skin ulcer, active fundal hemorrhage or end-stage renal disease)

Design outcomes

Primary

Measure	Time frame
The primary outcomes measured are pre-frailty or frailty at 3 and 12 months. They are assessed using the OSHPE (Obu Study Health Promotion for the Elderly)'s criteria.	—

Countries

Japan

Contacts

Public ContactTakahisa Tanikawa

National Center for Geriatrics and Gerontology Endocrinology, Diabetes and Metabolism

hoisan@ncgg.go.jp0562-46-2311

Outcome results

None listed

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