A Multi-domain Lifestyle Intervention Among Aged Community-residents in Zhejiang, China

Обзор

A study conducted in Finland discovered that a multidomain intervention, consisting of physical activity, nutritional guidance, cognitive training, social activities, and management of vascular risk factors, effectively decelerated cognitive decline in healthy older adults who were at an increased risk of cognitive decline. The HERITAGE study is a 2-year clustered randomized controlled trial (clustered-RCT) that explores the efficacy of a multidomain intervention among 1200 elderly residents with a higher risk of cognitive decline and dementia in Zhejiang Province, China

Подробное описание

The effectiveness of a multidomain lifestyle intervention on the prevention of cognitive decline and dementia have not been studied in Asian elderly at high risk of dementia conversion. Dementia is caused by both nonmodifiable genetic variables, and modifiable lifestyle risk factors. While neuroimaging biomarkers have been well documented in the neurophysiology of ageing and age-associated cognitive decline, their role as surrogate endpoints and intermediate variables between multi-domain lifestyle intervention and cognitive benefits has not been studied. The current study aims to understand brain functional and structural changes that may result from a multi-domain lifestyle intervention and whether the changes correlate with improvement in cognitive function. At risk elderly aged 60-80 years will be randomly allocated to either the control arm (self-guided management) or the intervention (multi-domain lifestyle) arm, which consists of nutritional guidance, physical exercise, cognitive training and the monitoring and management of vascular and metabolic risk factors. We hypothesize that the multi-domain lifestyle intervention will promote favorable changes in cognitive function. Moreover, such intervention will slow down the progression of cerebrovascular disease and neurodegeneration in participants in the intervention arm. Findings from the present study will shed light on the biological mechanisms of age-related cognitive decline and neurodegenerative disease. Insight obtained from the study could be translated into new targets of nonpharmacological interventions which aim at the potential causal molecular pathways implicated in ageing and age-related cognitive decline. Adaption and implementation of our findings into clinical and public health practice will further promote healthy and confident ageing among Chinese elderly, to eventually expand their health span.

Вмешательства

• Поведенческое Structured Multi-domain Intervention
  Structured Multi-domain Intervention (SMI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
• Поведенческое Self-Guided Intervention
  In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.

Первичные конечные точки

• Global Cognition [Срок оценки: Up to 2 years]
• Domain-specific Cognition [Срок оценки: Up to 2 years]

Вторичные конечные точки (12)

• Neuroimaging: MRA [Срок оценки: Up to 2 years]
• Neuroimaging: MRI [Срок оценки: Up to 2 years]
• Neuroimaging: fMRI [Срок оценки: Up to 2 years]
• Number of participants with Laboratory Values /Blood markers [Срок оценки: Up to 2 years]
• Incident dementia [Срок оценки: Up to 2 years]
• Clinical Dementia Rating-Sum of Boxes (CDR-SB) [Срок оценки: Up to 2 years]
• Alzheimer's Disease Cooperative Study Activities of Daily Living Mild Cognitive Impairment-Activities of Daily Living Inventory (ADCS MCI-ADL) [Срок оценки: Up to 2 years]
• Cardiovascular morbidity [Срок оценки: Up to 2 years]
• Physical Performance: Grip strength [Срок оценки: Up to 2 years]
• Physical Performance: Gaid speed [Срок оценки: Up to 2 years]
• Physical Performance: Balance [Срок оценки: Up to 2 years]
• Physical Performance: Endurance [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

• At risk of cognitive decline: cognitive performance at the mean level or slightly lower than expected for age with no dementia (AD8>=3 and/or 5-min MoCA >, < 11)
• Free of physical disabilities that preclude participation in the study
• Willing to complete all study-related activities for 24 months
• Willing to be randomized to either lifestyle intervention group

Критерии исключения

• Diagnosed dementia patients
• Diagnosed major depression or other neuropsychological diseases
• Malignant diseases
• Symptomatic cardiovascular disease
• Revascularization within one year
• Severe loss of vision, hearing or communicative ability

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• School of Public Health and The Second Affiliated Hospital of School of Medicine, Zhejiang — Ханчжоу

Публикации

• Xu X, Chew KA, Wong ZX, Phua AKS, Chong EJY, Teo CKL, Sathe N, Chooi YC, Chia WPF, Henry CJ, Chew E, Wang M, Maier AB, Kandiah N, Chen CL. The SINgapore GERiatric Intervention Study to Reduce Cognitive Decline and Physical Frailty (SINGER): Study Design and Protocol. J Prev Alzheimers Dis. 2022;9(1):40-48. doi: 10.14283/jpad.2022.5. PMID 35098972
• Zhao X, Hu R, Wen H, Xu G, Pang T, He X, Zhang Y, Zhang J, Chen C, Wu X, Xu X. A voice recognition-based digital cognitive screener for dementia detection in the community: Development and validation study. Front Psychiatry. 2022 Jul 22;13:899729. doi: 10.3389/fpsyt.2022.899729. eCollection 2022. PMID 35935417

Идентификаторы

NCT: NCT05886114 · 31005808A111272274170

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗