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

Autor: Teh R; Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand. r.teh@auckland.ac.nz., Kerse N; School of Population Health, University of Auckland, Auckland, New Zealand., Waters DL; Department of Medicine, School of Physiotherapy, University of Otago, Dunedin, New Zealand., Hale L; Centre for Health, Activity and Rehabilitation Research, School of Physiotherapy, University of Otago, Dunedin, New Zealand., Pillai A; Department of Statistics, Faculty of Science, University of Auckland, Auckland, New Zealand., Leilua E; Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand., Tay E; Department of General Practice and Primary Health Care, School of Population Health, University of Auckland, Auckland, New Zealand., Rolleston A; The Centre of Health, Tauranga, New Zealand., Edlin R; Health Systems Group, School of Population Health, University of Auckland, Auckland, New Zealand., Maxted E; Lakes District Health Board, Rotorua, New Zealand., Heppenstall C; Department of Medicine, University of Otago, Christchurch, New Zealand., Connolly MJ; Department of Geriatric Medicine, University of Auckland, Auckland, New Zealand.; Waitemata District Health Board, Auckland, New Zealand.
Jazyk: angličtina
Zdroj: Aging clinical and experimental research [Aging Clin Exp Res] 2019 Oct; Vol. 31 (10), pp. 1407-1417. Date of Electronic Publication: 2019 Jan 02.
DOI: 10.1007/s40520-018-1106-7
Abstrakt: 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.
Databáze: MEDLINE
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