An Evidence-Based Cognitive Stimulation and Physical Activity Intervention to Delay Aging-Related Decline: Protocol for a Randomized Controlled Trial.

backgroundThe aging population presents both opportunities and challenges. Both global and Malaysian statistics have shown that an increase in longevity is also marked by an increase in the time spent in poor health. A key measure of healthy aging is the ability to lead an independent life. This has implications not only for the individual's quality of life but also for society as a whole; loss of independence with age is associated with increased economic burden and reduced workforce productivity. Understanding and subsequently addressing these age-related declines (slowing or reversing them) is critical in improving the health and societal challenges faced by older adults. However, most studies are focused on Western populations. The scarcity of interventions tailored to multiethnic Asian populations is compounded by the fact that existing measurements rely heavily on Western-designed psychometric instruments, which frequently fail in capturing true cognitive health because of large cultural and educational gaps.

objectiveWe aim to examine whether our long-term intervention packages can, over 4 years, significantly slow down the normal rate of aging-related decline in cognitive function and brain structure and function, as well as assess changes in aging-related salivary biomarkers. We will also measure the economic impact of such interventions in a cost-benefit analysis.

methodsWe propose 3 ecologically valid intervention packages (cognitive stimulation, physical activity, or both combined) and aim to assess them against a control group. We will target a sample of 400 participants as representative of the population of community-dwelling aging citizens in Malaysia (aged 60 years and older). The 5 projects of this study examined (1) psychology (social interaction and emotional well-being); (2) neuroscience, looking at neural markers of cognition (magnetic resonance imaging and electroencephalogram); (3) decision-making (risk and challenges in decision making); (4) economics (cost-benefits and effectiveness of the study interventions); and (5) biological markers of aging, using salivary samples. The Sunway University Institutional Review Board has reviewed and approved the study (SUREC2020/039).

resultsBriefly, primary outcomes will include changes in cognitive scores (Montreal Cognitive Assessment), changes in cognitive behavioral measurements, changes in electroencephalogram and structural magnetic resonance imaging, changes in everyday problem-solving and Iowa gambling task scores, changes in salivary biomarkers (lactoferrin, C-reactive protein, and telomere length), and cost-benefit analysis of the intervention. The study grant was awarded in August 2019, with recruitment starting in May 2022 and concluding in July 2023. In 2023, the intervention phase began and is currently ongoing, with the first publications of outcomes expected in 2026.

conclusionsThe effectiveness of these interventions will be examined from the perspective of multiple disciplines, including psychology, neuroscience, biology, and economics. We anticipate that the results of our study will be of interest to both the academic and general community and will hopefully influence policymaking. We hope that this study will provide robust and impactful, evidence-based insights on healthy aging and, thus, contribute to improving the overall quality of life associated with aging.

trial registrationClinicalTrials.gov NCT06376656; https://clinicaltrials.gov/study/NCT06376656. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/88268.