Cognitive Training for Sedentary Lifestyle

(BOOST Trial)

Recruiting at 1 trial location

Overseen By Charles Hillman, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Cardiovascular disease, Neurological conditions, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

264 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if cognitive training (also known as cognitive therapy or neurocognitive training) can help people maintain a regular exercise routine. Participants will use various game-like programs at home to enhance their mental control, potentially making it easier to stay active. The trial also investigates why this approach may be more effective for some individuals than others. It suits full-time workers aged 40 to 65 who engage in minimal physical activity and can safely participate in an exercise program. As an unphased trial, this study provides participants with an opportunity to contribute to innovative research that could improve exercise adherence for many.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you have a condition that requires medication and is listed in the exclusion criteria, you may not be eligible to participate.

What prior data suggests that these cognitive training strategies are safe for improving physical activity adherence?

Research has shown that cognitive training is generally safe. It has been used with many people, including older adults and cancer patients, without major side effects. This method doesn't involve drugs, which often means fewer risks. Some studies have found that combining cognitive training with exercise can benefit people who don't get much physical activity. These studies also report no serious safety issues.

In this trial, participants will use game-like programs at home for cognitive training. These programs are designed to be fun and easy to adjust, making them comfortable to use. Similar situations have reported no negative effects from this type of training.

Overall, cognitive training is considered a safe option, especially compared to treatments involving medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cognitive training programs for sedentary lifestyles because they offer a fresh approach to boosting physical activity through mental engagement. Unlike traditional exercise programs that focus solely on physical routines, these experimental treatments incorporate game-like cognitive tasks that participants can do at home, aiming to make the process more engaging and rewarding. The "Emotionally Valenced" version uses emotional stimuli to potentially enhance motivation and cognitive engagement, while the "Neutral" version adjusts difficulty levels based on performance to keep participants challenged. This innovative method might encourage more consistent participation and improve overall lifestyle habits by making mental and physical health activities more interconnected and enjoyable.

What evidence suggests that this trial's treatments could be effective for improving physical activity adherence?

Research has shown that brain exercises, such as those tested in this trial, can help individuals maintain their physical activity routines by enhancing self-control. Participants may engage in various cognitive training programs, including Cognitive Control: Emotionally Valenced (CC-E) or Cognitive Control: Neutral (CC-N). Studies have found that combining brain exercises with physical exercise enhances brain health by increasing a protein called BDNF, crucial for brain function. These activities can improve memory and decision-making, which are essential for sustaining an exercise routine. For older adults who are not very active, these programs can enhance thinking skills, such as remembering and planning, making it easier to remain active. Overall, evidence suggests that these brain exercises effectively support a more active lifestyle. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for middle-aged adults who live a sedentary lifestyle and are looking to become more physically active. Participants should be willing to undergo cognitive training, exercise programs, and lab assessments. Specific eligibility criteria have not been provided.

Inclusion Criteria

I work full-time, at least 35 hours a week.

My doctor has approved my participation in the training program.

Eligible to participate in an aerobic exercise intervention based on the Physical Activity Readiness Questionnaire

Exclusion Criteria

I have been diagnosed with Alzheimer's or a similar memory disorder.

Pregnant or trying to get pregnant

Impairments in hearing inhibiting the ability to discuss study instructions or directions

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cognitive Training

Participants complete a 6-week home-based, computerized cognitive training program with 15 hours of progressive adaptive training.

6 weeks

2 visits (in-person) for pre- and post-cognitive training assessments

Exercise Training

Participants complete a 12-week exercise program, starting with a 6-week supervised training followed by a 6-week home-based maintenance program.

12 weeks

2 visits (in-person) for pre- and post-exercise training assessments

Follow-up

Participants are monitored for safety and effectiveness after the exercise training program.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive training
• Exercise

Trial Overview The study is testing if cognitive training can help people stick to an exercise routine better. It includes a 6-week computerized program at home aimed at improving self-control, followed by another 6 weeks of supervised aerobic exercises.

How Is the Trial Designed?

Group I: Cognitive Control: Neutral (CC-N) Experimental Treatment 2 Interventions

Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented are neutral (not emotionally valenced). After each session, the difficulty of the next session is updated.

Group II: Cognitive Control: Emotionally Valenced (CC-E) Experimental Treatment 2 Interventions

Game-like cognitive training program that they will run themselves at home up to 5 times per week. A game-like experience begins, where the participant is encouraged to earn points and in-game rewards to advance. In this condition, all the stimuli presented within the tasks are emotionally valenced.

Group III: Casual Games Active Control 2 Interventions

Composed of 6 commercially available computer games. It matches the experimental treatment program in overall program use intensity, time-spent attending, delivered rewards, and overall engagement.

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials

486

Recruited

934,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A study involving 25 participants aged 65-85 showed that 12 sessions of virtual reality cognitive exercises led to significant improvements in visual memory, attention, and cognitive flexibility.

Participants with lower baseline cognitive performance benefited the most from the training, suggesting that ICT-based exercises can be particularly effective for those experiencing greater cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Stimulation of Elderly Individuals with Instrumental Virtual Reality-Based Activities of Daily Life: Pre-Post Treatment Study. Gamito, P., Oliveira, J., Morais, D., et al.[2019]

The SmartTapestry device, tested on 53 participants (29 healthy and 24 with mild cognitive impairment), effectively combines physical activity with cognitive training, showing a strong correlation with traditional cognitive tasks.

This innovative approach suggests that cognitive-physical training tools can enhance cognitive function while being used at home, potentially improving treatment efficacy for cognitive impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can physical and cognitive training based on episodic memory be combined in a new protocol for daily training? Maselli, M., Fiorini, L., Cecchi, F., et al.[2020]

A study involving 151 healthy elderly individuals (70 years and older) found that a 12-week cognitive training program did not lead to significant long-term improvements in cognitive functioning five years later, as assessed by various neuropsychological tests.

While some measures showed better performance in the intervention group compared to the control group, none of these differences were statistically significant, suggesting that brief cognitive training may not be effective in preventing cognitive decline in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Five-year follow-up study of multi-domain cognitive training for healthy elderly community members. Feng, W., Li, C., Chen, Y., et al.[2021]

A study involving 45 patients with neurological and psychiatric conditions showed that using a web-based cognitive training system, 'COGWEB', resulted in high adherence rates, with 82.8% of participants complying with their treatment plan over 18 months.

Patients with dementia engaged in more intensive training (averaging 444.6 minutes/week), and those who attended face-to-face sessions performed even better, highlighting that combining traditional methods with technology can enhance cognitive training effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based cognitive training: patient adherence and intensity of treatment in an outpatient memory clinic. Tedim Cruz, V., Pais, J., Alves, I., et al.[2021]

Cognitive stimulation and training may help preserve cognitive function in older adults, but more research is needed to fully understand their effects and mechanisms.

The review highlights the need for more randomized controlled trials with long-term follow-up to better assess the impact of cognitive interventions on aging and the risk of Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Healthy brain aging: role of cognitive reserve, cognitive stimulation, and cognitive exercises. La Rue, A.[2022]

Cognitive training, particularly through cognitive exercises, shows moderate to large beneficial effects on memory outcomes in individuals with mild cognitive impairment (MCI), based on a systematic review of 10 studies involving 305 subjects.

The review highlights that previous studies may have underestimated the efficacy of cognitive training due to unclear definitions of interventions, emphasizing the need for more high-quality randomized controlled trials to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and memory training in adults at risk of dementia: a systematic review. Gates, NJ., Sachdev, PS., Fiatarone Singh, MA., et al.[2023]

Cognitive training (CT) over 16 weeks did not significantly improve cognitive outcomes or wellbeing in 135 white-collar employees, suggesting limited efficacy for this intervention in the workplace.

In contrast, an active control group that engaged in watching documentaries showed significant improvements in Quality of Life, reduced stress levels, and enhanced Psychological Wellbeing, highlighting the potential benefits of simple respite activities for employee mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Putting brain training to the test in the workplace: a randomized, blinded, multisite, active-controlled trial. Borness, C., Proudfoot, J., Crawford, J., et al.[2021]

Cognitive training and physical exercise can enhance cognitive performance and physical functioning in older adults, with exercise showing significant improvements in physical capacity and some cognitive domains, regardless of frailty status.

While cognitive training may have limited transfer effects to untrained tasks, computerized dual-task training has been effective in improving balance and postural control, indicating that certain training methods can lead to broader benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive plasticity in older adults: effects of cognitive training and physical exercise. Bherer, L.[2022]

A 10-week community-based computerized cognitive training (CCT) program for 94 healthy older adults showed improvements in attention and executive function, indicating its potential effectiveness for cognitive enhancement in this population.

While the program had high participation rates, it struggled to engage more sedentary older adults, highlighting a barrier to broader implementation in community settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the Implementation and Effectiveness of Community-Based Brain-Computer Interface Cognitive Group Training in Healthy Community-Dwelling Older Adults: Randomized Controlled Implementation Trial. Yeo, PS., Nguyen, TN., Ng, MPE., et al.[2021]

Cognitive training combined with physical activity (CPT) showed stronger long-term effects on attention in older adults compared to cognitive training alone (CT), particularly noticeable at a 1-year follow-up after 6.5 weeks of training.

Both CPT and CT improved cognitive functions such as cognitive state, verbal fluency, and memory, but the specific benefits of CPT may be influenced by ongoing physical activity after the training sessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cognitive training with additional physical activity compared to pure cognitive training in healthy older adults. Rahe, J., Petrelli, A., Kaesberg, S., et al.[2019]

Cognitive training has been shown to significantly improve subjective cognitive function and certain objective cognitive skills, such as working memory and episodic memory, in breast cancer patients experiencing cognitive changes, based on a systematic review of 9 randomized controlled trials involving 666 patients.

Despite these improvements, cognitive training did not lead to significant changes in attention, short-term memory, executive function, or psychological outcomes like anxiety and depression, indicating that while cognitive training can be beneficial, it may not address all cognitive and emotional challenges faced by these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. Yan, X., Wei, S., Liu, Q.[2023]

The SMART trial will investigate the effects of cognitive training (CT) and progressive resistance training (PRT) on cognitive function and independence in 132 older adults at risk for cognitive decline, using a double-blind, randomized design over 6 months.

This study aims to identify not only the cognitive benefits of these interventions but also their impact on brain health, physical fitness, and overall well-being, potentially revealing mechanisms that contribute to slowing cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Mental Activity and Regular Training (SMART) in at risk individuals: a randomised double blind, sham controlled, longitudinal trial. Gates, NJ., Valenzuela, M., Sachdev, PS., et al.[2022]

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Effectiveness of Combined Cognitive Stimulation and ... Physically active lifestyles significantly improve cognitive functions (p < 0.01), notably memory and executive abilities, by promoting neurogenesis, increasing ...

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Cognitive Training for Sedentary Lifestyle (BOOST Trial) Cognitive training is considered a safe, non-drug approach that has been used in various groups, including older adults and cancer patients, without significant ...