Study protocol for 'the effects of multimodal training of cognitive and/or physical functions on cognition and physical fitness of older adults: a cluster randomized controlled trial'.

Background: The elderly population worldwide is increasing exponentially which will be associated with more people suffering from cognition and fitness declines. The well-established benefits of exercise training for the elderly's cognitive and physical functioning have been observed. However, the amalgamated effect of combining cognitive and physical exercises on the older adults' cognitive functions, physical fitness, or psycho-related health remains unclear. Thus, this study protocol was planned to conduct different combinations of cognitive and/or physical training interventions to community-dwelling older adults and expected to see the multifaceted effects of the varied combination of training on their health.

Methods: This study is a cluster randomized controlled trial (CRCT). A total of 285 older adults (age ≥ 60) from twenty elderly centres as clusters will be randomly selected and assigned to intervention groups (IGs, n = 16) or control groups (CGs, n = 4). Each IG will be randomly assigned to one of the four combinations of three training modes that include cognitive (A), physical (B), and combined cognitive and physical training (CCPT, i.e. C), namely Mixed ABC, A + B, C + A, B + C. The intervention will last for 4 months in which the training is conducted for 16 sessions, 2 sessions per week, and 60 min per session. Four repeated assessments (pre-test, two post-training tests after 2 months and 4 months, and a follow-up test) will be conducted. The CG will only receive the four repeated assessments but no intervention. The outcome measures include cognitive tests (tests of execution, memory, and psych-social status), physical fitness, and dynamic balance tests.

Discussion: This study will provide substantial evidence that the integrated format of cognitive and physical exercises training will have higher cognition and fitness impact than the single training modes, and all these mixed modalities will have greater positive outcomes than the control condition. If the effectiveness is proven, the intervention can be further explored and extended to the nation so that many more elderly would be benefited.

Trial Registration: The trial has been registered in the ClinicalTrials.gov in U.S. NIH (ID: NCT04727450 , date: January 27, 2021).