Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults

一项随机对照试验的研究方案,旨在检验一项复杂干预措施对衰弱前期老年人的影响

阅读:1

Abstract

BACKGROUND: Frailty is a multidimensional geriatric syndrome associated with functional loss. The Senior Chef (SC, nutrition) and SAYGO (strength and balance exercise) programmes are well accepted among older adults but the impact of each, or a combination of both, on the frailty syndrome in pre-frail older adults is unknown. AIMS: To determine the effectiveness and cost-effectiveness of a complex intervention consisting of the SC and/or SAYGO programmes to prevent progression of frailty in pre-frail older adults. METHODS: A multi-centre randomised controlled assessor-blinded study. The four intervention groups are SC, an 8-week nutrition education and cooking class; SAYGO, a 10-week strength and balance exercise class; SC plus SAYGO, and a social group (Control). Community-dwelling adults aged 75+ (60 + Māori and Pasifika) in New Zealand are recruited through health providers. Participants are not terminally ill or with advanced dementia, and have a score of 1 or 2 on the FRAIL questionnaire. Baseline assessments are completed using standardised questionnaires prior to randomisation. Four follow-up assessments are completed: immediately after intervention, 6, 12 and 24 months post-intervention. The primary outcome is frailty score, secondary outcomes are falls, physical function, quality of life, food intake, physical activity, and sustainability of the strategy. Study outcomes will be analysed using intention-to-treat approach. Cost analyses will be completed to determine if interventions are cost effective relative to the control group. DISCUSSION: This trial is designed to be a real world rigorous assessment of whether the two intervention strategies can prevent progression of frailty in older people. If successful, this will generate valuable information about effectiveness of this nutrition and exercise strategy, and provide insights for their implementation. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry number-ACTRN12614000827639.

特别声明

1、本页面内容包含部分的内容是基于公开信息的合理引用;引用内容仅为补充信息,不代表本站立场。

2、若认为本页面引用内容涉及侵权,请及时与本站联系,我们将第一时间处理。

3、其他媒体/个人如需使用本页面原创内容,需注明“来源:[生知库]”并获得授权;使用引用内容的,需自行联系原作者获得许可。

4、投稿及合作请联系:info@biocloudy.com。