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. 2019 Oct;31(10):1407-1417.
doi: 10.1007/s40520-018-1106-7. Epub 2019 Jan 2.

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

Ruth Teh  1 , Ngaire Kerse  2 , Debra L Waters  3 , Leigh Hale  4 , Avinesh Pillai  5 , Evelingi Leilua  6 , Esther Tay  6 , Anna Rolleston  7 , Richard Edlin  8 , Eruera Maxted  9 , Claire Heppenstall  10 , Martin J Connolly  11   12
Affiliations

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

Ruth Teh et al. Aging Clin Exp Res. 2019 Oct.

Erratum in

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.

Keywords: Cost effectiveness; Frailty; Nutrition; Older adults; Physical activity.

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Conflict of interest statement

The authors declare that they have no competing interests.

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Study flowchart
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