Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults.
Accidental Falls
/ prevention & control
Aged
Aged, 80 and over
Australia
Cost-Benefit Analysis
Exercise
Exercise Therapy
/ methods
Female
Frail Elderly
Frailty
/ economics
Humans
Independent Living
Male
Multicenter Studies as Topic
Outcome Assessment, Health Care
Quality of Life
Randomized Controlled Trials as Topic
Surveys and Questionnaires
Cost effectiveness
Frailty
Nutrition
Older adults
Physical activity
Journal
Aging clinical and experimental research
ISSN: 1720-8319
Titre abrégé: Aging Clin Exp Res
Pays: Germany
ID NLM: 101132995
Informations de publication
Date de publication:
Oct 2019
Oct 2019
Historique:
received:
07
08
2018
accepted:
14
12
2018
pubmed:
4
1
2019
medline:
19
11
2019
entrez:
4
1
2019
Statut:
ppublish
Résumé
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. 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. 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. 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. Australian and New Zealand Clinical Trials Registry number-ACTRN12614000827639.
Sections du résumé
BACKGROUND
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
OBJECTIVE
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
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
CONCLUSIONS
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
BACKGROUND
Australian and New Zealand Clinical Trials Registry number-ACTRN12614000827639.
Identifiants
pubmed: 30604208
doi: 10.1007/s40520-018-1106-7
pii: 10.1007/s40520-018-1106-7
pmc: PMC9203378
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1407-1417Subventions
Organisme : Ministry of Business, Innovation and Employment
ID : 12815/1, SUB1341
Organisme : Health Research Council of New Zealand
ID : 14/604
Commentaires et corrections
Type : ErratumIn
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