Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Kowloon, Hong Kong, SAR, China.
Department of Physical Therapy, College of Rehabilitation Sciences, University of Santo Tomas, Manila, Philippines.
BMC Geriatr. 2018 Aug 24;18(1):193. doi: 10.1186/s12877-018-0868-2.
BACKGROUND: The presence of mild cognitive impairment (MCI) in older adults increases their fall risk. While physical exercise is effective in reducing falls rate and risk of falls, and cognitive training in improving cognitive functioning in healthy older adults, their effectiveness in preventing falls and reducing risks of falls in MCI when administered simultaneously is not yet established. Therefore, this study aims to determine the effectiveness of combined physical and cognitive training in preventing falls and decreasing risks of falls among community-dwelling older persons with MCI. METHODS/DESIGN: This is a single-blind, multicentre, randomized controlled trial. At least ninety-three community-dwelling older adults with MCI aged 60 or above will be recruited. They will be randomly allocated into four groups: Physical Training alone (PT), Cognitive Training alone (CT), combined Physical And Cognitive Training (PACT) and Waitlist Group (WG). The PT group will perform exercises (flexibility, endurance, strengthening, and balance training) for 60-90 min three times per week for 12 weeks. The CT group will be involved in a paper-based training focusing on orientation, memory, attention and executive functioning for 60-90 min per session, once a week for 12 weeks. The PACT group will undergo cognitive training incorporated in physical exercise for 60-90 min three times per week for 12 weeks. The WG will receive the intervention, combined physical and cognitive training, at a later date. Assessors blinded to participant allocation will conduct pre-intervention, post-intervention, and 6-month follow-up assessments. The primary outcome measure will be falls rate. The secondary outcome measures will be Physiologic Profile Assessment and Falls Risk for Older Persons in the Community, and assessments that evaluate cognitive, physical and psychological factors related to falls. DISCUSSION: Considering the possible physical, social, financial and psychological consequences of a fall, we hope to provide insights on the effectiveness of combining physical and cognitive training on falls and fall-related factors for older adults with MCI. It is projected that the combined interventions will lead to significantly lower falls rate and reduced risk of falls compared to using single or no intervention. TRIAL REGISTRATION: ClinicalTrials.gov NCT03167840 . Registered on May 30, 2017.
背景：老年人轻度认知障碍（MCI）的存在会增加他们跌倒的风险。虽然体育锻炼可有效降低跌倒率和跌倒风险，认知训练可改善健康老年人的认知功能，但在同时进行时，它们在预防 MCI 患者跌倒和降低跌倒风险方面的效果尚未确定。因此，本研究旨在确定联合身体和认知训练在预防社区居住的 MCI 老年人跌倒和降低跌倒风险方面的有效性。
方法/设计：这是一项单盲、多中心、随机对照试验。将招募至少 93 名年龄在 60 岁或以上、居住在社区的 MCI 老年人。他们将被随机分配到四个组：单独进行体育锻炼（PT）、单独进行认知训练（CT）、联合进行身体和认知训练（PACT）和候补组（WG）。PT 组将每周进行 3 次、每次 60-90 分钟的锻炼（灵活性、耐力、力量和平衡训练），持续 12 周。CT 组将参加每周 1 次、每次 60-90 分钟的基于纸张的训练，重点是定向、记忆、注意力和执行功能，持续 12 周。PACT 组将在 12 周内每周 3 次、每次 60-90 分钟进行认知训练，同时进行身体锻炼。WG 将在稍后的时间接受联合身体和认知训练的干预。对参与者分配不知情的评估人员将在干预前、干预后和 6 个月随访时进行评估。主要结局指标将是跌倒率。次要结局指标将是社区老年人生理概况评估和跌倒风险，以及评估与跌倒相关的认知、身体和心理因素的评估。
讨论：考虑到跌倒可能带来的身体、社会、经济和心理后果，我们希望为 MCI 老年人提供关于联合身体和认知训练对跌倒和与跌倒相关因素的有效性的见解。预计联合干预将导致跌倒率显著降低，跌倒风险降低，与使用单一干预或不干预相比。
试验注册：ClinicalTrials.gov NCT03167840。注册于 2017 年 5 月 30 日。
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