A multicomponent frailty intervention in community-dwelling elderly persons

Not Applicable

Suspended

• Conditions: Frailty; Musculoskeletal Diseases

• Registration Number: ISRCTN17143761
• Lead Sponsor: AP-OSIs Gipuzkoa

Brief Summary

2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32086358/ (added 06/09/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-02
• Study Completion: 2021-12-31
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Subjects aged over 70 years, presenting frailty (SPPB <10), who are autonomous (Barthel > 90 points), resident in the autonomous community in question and agree to participate.

Exclusion Criteria

1. Subjects who are terminally ill (as defined in the guidelines published by the Spanish Society of Palliative Care)
2. Subjects who do not habitually reside in the study area (i.e. those who reside for more than six months per year elsewhere)
3. Those who have difficulty in communication in Spanish or Basque (the latter language, for subjects resident in Gipuzkoa)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At baseline and twelve months’ follow-up:<br>1. Functional capacity measured by the stand up and walk test. A cut-off point of 12 seconds will be applied to identify subjects with low functional capacity.<br>2. The incidence of adverse events, a score less than or equal to 90 points in the Barthel test will be considered to represent dependency. Other adverse events assessed during the follow-up year will be institutionalisation and hospitalisations (by number, hospital service required, type – programmed or urgent – and duration).