Study Protocol to Investigate the Effect of a Novel Aerobic Exercise Intervention With Integrated Cognitive Training, Active4Brain, on Cognition, Neurophysiology, and Neuroprotective Markers in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change from Baseline in Executive Function - Multitasking test from the CANTAB Research Connect
研究概览
简要总结
This study aims to examine the cognitive, neuronal, and physical effects of the Activ4Brain program in older men and women between 55 and 75 years of age. The program Activ4Brain consists of 24 sessions of aerobic exercise classes (twice a week over 3 months) that include computerized games designed to train cognition. Participants are tested before and after the 3-months intervention. Researchers will study changes in cognitive function, brain and body physiological activity, and inflammation and neuroprotective markers in 3 groups of participants: the Activ4Brain group that engages in the Activ4Brain program, an active control group that engages in aerobic exercise classes and a passive control group that does not engage in any intervention.
This study aims to answer the following questions.
- Does the program Activ4Brain improve cognition in cognitively healthy older adults?
- Does the program Activ4Brain change brain function and body physiology in cognitively healthy older adults?
详细描述
Cognitive training and physical exercise hold the potential to be successful non-pharmacological treatments for age-related cognitive decline and dementia. However, existing interventions show little to no benefit for preventing or delaying cognitive decline, highlighting the need to develop alternative tools. With this in mind, the Activ4Brain program was designed as a non-pharmacological strategy to reduce the impact of age-related cognitive decline. The Activ4Brain program consists of group aerobic exercise classes where computerized games targeting different cognitive domains are applied during the session to potentiate the effect of physical exercise on cognition. This study investigates the impact of this novel program on cognitive and brain function.
The primary objective of this study is:
• Evaluation of the efficacy of the Activ4Brain program in improving cognition in older people
Secondary objectives are:
- Evaluation of the impact of the Activ4Brain program on brain and autonomic function and physical health markers
- Evaluation of participants' adherence and retention through attendance rates across all intervention sessions and participation trends over time
- Evaluation of the feasibility of the Activ4Brain program including its acceptability, accessibility, and usability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 55 and 75 years of age
排除标准
- •Presence of contraindications for physical exercise screened with the Physical Activity Readiness Questionnaire (PAR-Q)
- •Presence of objective cognitive impairment screened with the Addenbroke's Cognitive Examination - Revised, which also incorporates the Mini Mental State Examination, providing a double score
- •Presence of high fall risk screened with the Timed Up and Go test (TUG)
- •Presence of severe neurological or psychiatric conditions
研究组 & 干预措施
Activ4Brain Group
Participants in this group perform the Activ4Brain program during 3 months
干预措施: Activ4Brain Program (Behavioral)
Aerobic exercise group
Participants in this group perform an Aerobic Exercise program during 3 months
干预措施: Aerobic Exercise Program (Behavioral)
Control group
Participants in this group receive no intervention during the study and are instructed to carry on their daily routines.
结局指标
主要结局
Change from Baseline in Executive Function - Multitasking test from the CANTAB Research Connect
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Executive function will be assessed with the Multitasking test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in MTT Multitasking cost (median). The score is calculated by subtracting the median latency of response during single task block(s) from the median latency of response during multitasking block(s). A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information. Lower values are associated with better executive function.
Change from Baseline in Working Memory - Spatial Working Memory (SWM) test from the CANTAB Research Connect
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Working memory will be assessed with the Spatial Working Memory (SWM) test from the CANTAB Research Connect (Cambridge Cognition Ltd)- 3-months score change in SWM Between Errors: the number of times the subject incorrectly revisits a box in which a token has previously been found. Lower values are associated with better working memory abilities.
Change from Baseline in Episodic Memory - Auditory Verbal Learning Test
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Auditory Verbal Learning Test (AVLT) - 3-months score change in Total Learning: the sum of words remembered across Trial 1 through Trial 5. Higher values represent better memory abilities.
Change from Baseline in Sustained Attention - Rapid Visual Information Processing test from the CANTAB Research Connect
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Sustained attention will be assessed with the Rapid Visual Information Processing test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score changes in RVPA (subject's sensitivity to the target sequence). Higher values represent better sustained attention scores.
Change from Baseline in Processing Speed - Rapid Visual Information Processing test from the CANTAB Research Connect
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Processing speed will be assessed with the Rapid Visual Information Processing test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in RVP Median Response Latency (median response latency on correct trials). Lower values represent faster processing speed.
Change from Baseline in Processing Speed - Multitasking test from the CANTAB Research Connect
时间窗: From one month before the 3-months intervention up to one month after the end of the intervention.
Processing speed will be assessed with the Multitasking test from the CANTAB Research Connect (Cambridge Cognition Ltd) - 3-months score change in MTT Incongruency cost (difference between the median response latency on the congruent versus incongruent trials). A lower incongruency cost indicates that the subject processes conflicting information faster.
次要结局
- 1. Change from Baseline in the Amplitude of Event-Related Potentials Evoked during a Reinforcement Learning Task(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in Amplitude of Pupil Responses during a Reinforcement Learning Task.(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Amplitude of Task-Related Heart Rate Responses Evoked during a Reinforcement Learning Task.(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in Heart Rate Variability during Rest - time domain measures(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in Heart Rate Variability during Rest - frequency domain measures(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Blood Plasma Levels of Inflammatory Biomarkers(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Blood Plasma Levels of Anti-Inflammatory Biomarkers(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Vascular Endothelial Growth Factor-D (VEGF-D) Blood Serum Levels(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Insulin-Like Growth Factor 1 (IGF-1) Blood Serum Levels(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Neurotrophic Factors Blood Serum Levels(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Change from Baseline in the Concentration of Irisin Blood Serum Levels(From one month before the 3-months intervention up to one month after the end of the intervention.)
- Feasibility Outcomes: Adherence to the Intervention Protocols(One month after the intervention)
- Feasibility Outcomes: Retention(One month after the intervention)
- Feasibility Outcomes: Average Group Scores in Acceptability Scale(From the end of the intervention up to one month after the intervention.)
- Feasibility Outcomes: Average Group Scores in the System Usability Scale (SUS)(From the end of the intervention up to one month after the intervention.)
研究者
Maria Ribeiro
Principal Investigator
University of Coimbra