Exercise and Cognitive Training for Mild Cognitive Impairment
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Disqualifiers: Heart disease, Hypertension, Diabetes, Substance use, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The prevalence of dementia will double in the next three decades in the U.S.; effective treatment or prevention for dementia is urgently needed. The current exploratory project aims to evaluate and understand how the brain and cognition may improve after a 12-week intervention that combines brain training and aerobic exercise training to improve brain function, both in those with mild cognitive impairment (some with possible prodromal Alzheimer's disease) and with healthy aging. Findings from this pilot project will guide and refine the development of a future larger clinical trial that aligns with the goals of the National Alzheimer's Plan of Action (NAPA), especially regarding "Prevent and Effectively Treat Alzheimer's Disease (AD) by 2025.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Adaptive cognitive training, Brain Training, Cognitive Training, Neurocognitive Training, Combined, Combined Brain Training and Aerobic Exercise Training, Progressive aerobic exercise, Aerobic exercise, Physical activity, Cardiovascular exercise for Mild Cognitive Impairment?
Research suggests that cognitive training can improve thinking skills and delay cognitive decline in older adults with mild cognitive impairment. Additionally, aerobic exercise has been shown to enhance cognitive function in older adults, particularly when combined with cognitive training, as seen in studies involving individuals with cognitive impairments.
12345Is exercise and cognitive training safe for humans?
Research on exercise and cognitive training, including aerobic exercise and mental training, generally suggests these activities are safe for humans. Studies involving healthy elderly subjects and individuals with mild cognitive impairment or stroke have not reported significant safety concerns.
16789How is the treatment of exercise and cognitive training for mild cognitive impairment different from other treatments?
This treatment is unique because it combines physical exercise with cognitive training, potentially enhancing brain health more effectively than either approach alone. The combination aims to improve cognitive function by engaging both the body and mind, which may offer synergistic benefits not seen with standard treatments.
1231011Eligibility Criteria
This trial is for adults aged 50-80 with mild cognitive impairment (MCI), who are sedentary, fluent in English, and can use an iPad or computer. They must be able to live independently despite cognitive deficits. Those with a BMI over 40, severe medical conditions, or inability to undergo MRI due to metal implants or claustrophobia cannot participate.Inclusion Criteria
I have been diagnosed with mild cognitive impairment but can still take care of myself.
I am between 50 and 80 years old.
Ability to use and accessibility to an iPad or computer
+3 more
Exclusion Criteria
Estimated verbal IQ below 70, self-reported moderate to severe substance use disorder(s), severe chronic or acute medical or neuropsychiatric conditions that might confound measures, body mass index >40 kg/m2
I cannot access a computer or internet for training and won't go to the lab.
Unable to undergo MRI investigation due to claustrophobia or metal foreign bodies
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 12-week intervention combining brain training and aerobic exercise
12 weeks
3 visits per week for aerobic exercise, 5 visits per week for cognitive training
Follow-up
Participants are monitored for changes in brain structure, function, and cognitive performance
4 weeks
1 visit (in-person) for assessments
Participant Groups
The study tests if brain function improves after a combined 12-week program of brain training and aerobic exercise in people with MCI. It explores potential treatments for dementia by assessing changes in the brain and cognition through this dual intervention approach.
3Treatment groups
Experimental Treatment
Group I: Combined Cognitive and Aerobic ExerciseExperimental Treatment1 Intervention
Combined progressive aerobic exercise 3x/week for 12 weeks and adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks simultaneously.
Group II: Cognitive TrainingExperimental Treatment1 Intervention
Adaptive cognitive training on Cogmed 5x/week for a total of 25 sessions in 5-8 weeks.
Group III: Aerobic ExerciseExperimental Treatment1 Intervention
Progressive aerobic exercise 3x/week for 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of Maryland BaltimoreBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
Measuring the impact of cognitive and psychosocial interventions in persons with mild cognitive impairment with a randomized single-blind controlled trial: rationale and design of the MEMO+ study. [2022]Several studies have suggested that cognitive training is a potentially effective way to improve cognition and postpone cognitive decline in older adults with mild cognitive impairment (MCI). The MEMO+ study is a randomized, controlled, single-blind trial designed to test the efficacy, specificity, and long-term effect of a cognitive training intervention and a psychosocial intervention in persons with MCI.
Cardiovascular risk moderates the effect of aerobic exercise on executive functions in older adults with subcortical ischemic vascular cognitive impairment. [2022]Aerobic training (AT) can promote cognitive function in adults with Subcortical Ischemic Vascular Cognitive Impairment (SIVCI) by modifying cardiovascular risk factors. However, pre-existing cardiovascular health may attenuate the benefits of AT on cognitive outcomes in SIVCI. We examined whether baseline cardiovascular risk moderates the effect of a 6-month progressive AT program on executive functions with a secondary analysis of a randomized controlled trial in 71 adults, who were randomized to either: (1) 3×/week progressive AT; or (2) education program (CON). Three executive processes were measured: (1) response inhibition by Stroop Test; (2) working memory by digits backward test; and (3) set shifting by the Trail Making Test. Baseline cardiovascular risk was calculated using the Framingham cardiovascular disease (CVD) Risk Score (FCRS), and participants were classified as either low risk (
Reshaping the path of mild cognitive impairment by refining exercise prescription: a study protocol of a randomized controlled trial to understand the "what," "for whom," and "how" of exercise to promote cognitive function. [2022]Targeted exercise training is a promising strategy for promoting cognitive function and preventing dementia in older age. Despite the utility of exercise as an intervention, variation still exists in exercise-induced cognitive gains and questions remain regarding the type of training (i.e., what), as well as moderators (i.e., for whom) and mechanisms (i.e., how) of benefit. Both aerobic training (AT) and resistance training (RT) enhance cognitive function in older adults without cognitive impairment; however, the vast majority of trials have focused exclusively on AT. Thus, more research is needed on RT, as well as on the combination of AT and RT, in older adults with mild cognitive impairment (MCI), a prodromal stage of dementia. Therefore, we aim to conduct a 6-month, 2 × 2 factorial randomized controlled trial in older adults with MCI to assess the individual effects of AT and RT, and the combined effect of AT and RT on cognitive function and to determine the possible underlying biological mechanisms.
Cardiorespiratory fitness and cognitive functioning following short-term interventions in chronic stroke survivors with cognitive impairment: a pilot study. [2018]This study, a quasi-experimental, one-group pretest-post-test design, evaluated the effects on cognitive functioning and cardiorespiratory fitness of 8-week interventions (aerobic exercise alone and aerobic exercise and cognitive training combined) in patients with chronic stroke and cognitive impairment living in the community (participants: n=14, 61.93±9.90 years old, 51.50±38.22 months after stroke, n=7 per intervention group). Cognitive functions and cardiorespiratory fitness were evaluated before and after intervention, and at a 3-month follow-up visit (episodic memory: revised-Hopkins Verbal Learning Test; working memory: Brown-Peterson paradigm; attention omission and commission errors: Continuous Performance Test; cardiorespiratory fitness: peak oxygen uptake during a symptom-limited, graded exercise test performed on a semirecumbent ergometer). Friedman's two-way analysis of variance by ranks evaluated differences in score distributions related to time (for the two groups combined). Post-hoc testing was adjusted for multiple comparisons. Compared with before the intervention, there was a significant reduction in attention errors immediately following the intervention (omission errors: 14.6±21.5 vs. 8±13.9, P=0.01; commission errors: 16.4±6.3 vs. 10.9±7.2, P=0.04), and in part at follow-up (omission errors on follow-up: 3.4±4.3, P=0.03; commission errors on follow-up: 13.2±7.6, P=0.42). These results suggest that attention may improve in chronic stroke survivors with cognitive impairment following short-term training that includes an aerobic component, without a change in cardiorespiratory fitness. Randomized-controlled studies are required to confirm these findings.
Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. [2022]The extent to which mental and physical exercise may slow cognitive decline in adults with early signs of cognitive impairment is unknown. This article provides the rationale and methodology of the first trial to investigate the isolated and combined effects of cognitive training (CT) and progressive resistance training (PRT) on general cognitive function and functional independence in older adults with early cognitive impairment: Study of Mental and Regular Training (SMART). Our secondary aim is to quantify the differential adaptations to these interventions in terms of brain morphology and function, cardiovascular and metabolic function, exercise capacity, psychological state and body composition, to identify the potential mechanisms of benefit and broader health status effects.
Improvement of cognitive function by mental and/or individualized aerobic training in healthy elderly subjects. [2022]The aim of this study was to compare the effects of aerobic and mental training on cognitive function and to determine if the association of the two techniques shows better results. Thirty-two healthy elderly subjects (60 - 76 years) were assigned to one of four groups: aerobic training, mental training, combined aerobic and mental training and a control group. All subjects took two cognitive tests and an incremental exercise test before and after the training period. The intensity of exercise was individualized at the heart rate corresponding to the ventilatory threshold of each subject. After two months, the control group showed no alteration in physiological and cognitive variables. After the training period, the results showed a significant improvement in VO(2)max (F = 4.45, DF = 1, p
Relation of Aerobic Activity to Cognition and Well-being in Chronic Mild Traumatic Brain Injury: A LIMBIC-CENC Study. [2023]Because chronic difficulties with cognition and well-being are common after mild traumatic brain injury (mTBI) and aerobic physical activity and exercise (PAE) is a potential treatment and mitigation strategy, we sought to determine their relationship in a large sample with remote mTBI.
Exercise Training in Amnestic Mild Cognitive Impairment: A One-Year Randomized Controlled Trial. [2020]The current evidence is inconclusive to support the benefits of aerobic exercise training (AET) for preventing neurocognitive decline in patients with amnestic mild cognitive impairment (aMCI).
Effects of Combined Interventions with Aerobic Physical Exercise and Cognitive Training on Cognitive Function in Stroke Patients: A Systematic Review. [2021](1) Background: Stroke is a major cause of permanent disability in multiple functions, including the cognitive domain. Since both cognitive training and aerobic physical exercise may exert positive effects on cognition after stroke, one may expect synergistic benefits when combining both interventions. (2) Methods: We carried out a systematic search of studies testing, in adult stroke patients, whether structured aerobic exercise combined with cognitive training led to higher cognitive benefits than either of these interventions when applied singly, or than interventions not including aerobic exercise or cognitive training. (3) Results: Five fair-quality randomized controlled trials fulfilled the search criteria. Exercise intensity was moderate-vigorous and cognitive training was mainly computer-based. The studies were heterogeneous regarding the cognitive tests used, and for this reason, a meta-analysis was not performed. Only three studies included follow-up assessment. The combined intervention was associated with pre-post improvement in at least one cognitive test in all the studies, and with higher positive effects compared to other conditions (although statistical significance was not always reached) in four studies. (4) Conclusions: Further trials including a long-term follow-up and comprehensive neuropsychological testing should be undertaken to determine whether combined aerobic exercise and cognitive training leads to additive cognitive benefits after stroke.
The Aerobic and Cognitive Exercise Study (ACES) for Community-Dwelling Older Adults With or At-Risk for Mild Cognitive Impairment (MCI): Neuropsychological, Neurobiological and Neuroimaging Outcomes of a Randomized Clinical Trial. [2022]Prior research has found that cognitive benefits of physical exercise and brain health in older adults may be enhanced when mental exercise is interactive simultaneously, as in exergaming. It is unclear whether the cognitive benefit can be maximized by increasing the degree of mental challenge during exercise. This randomized clinical trial (RCT), the Aerobic and Cognitive Exercise Study (ACES) sought to replicate and extend prior findings of added cognitive benefit from exergaming to those with or at risk for mild cognitive impairment (MCI). ACES compares the effects of 6 months of an exer-tour (virtual reality bike rides) with the effects of a more effortful exer-score (pedaling through a videogame to score points). Fourteen community-dwelling older adults meeting screening criteria for MCI (sMCI) were adherent to their assigned exercise for 6 months. The primary outcome was executive function, while secondary outcomes included memory and everyday cognitive function. Exer-tour and exer-score yielded significant moderate effects on executive function (Stroop A/C; d's = 0.51 and 0.47); there was no significant interaction effect. However, after 3 months the exer-tour revealed a significant and moderate effect, while exer-score showed little impact, as did a game-only condition. Both exer-tour and exer-score conditions also resulted in significant improvements in verbal memory. Effects appear to generalize to self-reported everyday cognitive function. Pilot data, including salivary biomarkers and structural MRI, were gathered at baseline and 6 months; exercise dose was associated with increased BDNF as well as increased gray matter volume in the PFC and ACC. Improvement in memory was associated with an increase in the DLPFC. Improved executive function was associated with increased expression of exosomal miRNA-9. Interactive physical and cognitive exercise (both high and low mental challenge) yielded similarly significant cognitive benefit for adherent sMCI exercisers over 6 months. A larger RCT is needed to confirm these findings. Further innovation and clinical trial data are needed to develop accessible, yet engaging and effective interventions to combat cognitive decline for the growing MCI population. ClinicalTrials.gov ID: NCT02237560.
SYNERGIC TRIAL (SYNchronizing Exercises, Remedies in Gait and Cognition) a multi-Centre randomized controlled double blind trial to improve gait and cognition in mild cognitive impairment. [2019]Physical exercise, cognitive training, and vitamin D are low cost interventions that have the potential to enhance cognitive function and mobility in older adults, especially in pre-dementia states such as Mild Cognitive Impairment (MCI). Aerobic and progressive resistance exercises have benefits to cognitive performance, though evidence is somewhat inconsistent. We postulate that combined aerobic exercise (AE) and progressive resistance training (RT) (combined exercise) will have a better effect on cognition than a balance and toning control (BAT) intervention in older adults with MCI. We also expect that adding cognitive training and vitamin D supplementation to the combined exercise, as a multimodal intervention, will have synergistic efficacy.