Cognitive Task Performance During Fatigue

Overseen By Hugo Pereira

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Metal implants, joint replacement, neuromuscular disease

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how performing a mental task affects physical exhaustion. Researchers aim to understand how intense mental effort during tiring physical activities alters performance. The study includes four groups: young men, young women, older men, and older women. Healthy individuals aged 18-35 or 65-90, without metal implants or neuromuscular diseases, are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to groundbreaking research on mental and physical performance.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cognitive task is safe?

Research has shown that cognitive tasks are safe and easy to manage. Studies have found that brain exercises can enhance mental function without causing harm. For instance, one study noted that these exercises improved mood and cognition without any negative effects. Another study found that these tasks enhanced thinking skills in older adults with no reported side effects.

No specific side effects have been linked to cognitive tasks. These tasks typically involve activities that challenge the brain, such as puzzles or memory games. Since this trial does not involve a new drug or surgery, safety concerns remain minimal. Participants can rely on existing research to confirm the safety of cognitive tasks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how cognitive task performance is affected by fatigue across different age and gender groups. Unlike traditional studies that may focus on pharmacological interventions, this trial emphasizes understanding the natural cognitive responses to fatigue through familiarization and test sessions. This approach could lead to new insights into how fatigue impacts cognitive function differently in men and women, both young and old, potentially informing more personalized strategies for managing cognitive performance in everyday situations.

What evidence suggests that cognitive tasks are effective during fatiguing contractions?

Research has shown that mental exercises can improve thinking skills, even when fatigue sets in. In this trial, participants will engage in cognitive tasks to assess their impact on cognitive performance during fatigue. Cognitive Stimulation Therapy (CST) has improved overall thinking, language, and memory. Specifically, a 14-week CST program enhanced mental health in individuals with mild dementia. Additionally, cognitive training helped older adults manage daily activities better after the program. These findings suggest that mental exercises might effectively boost thinking skills and mental health, even during fatigue. ^{6 7 8 9 10}

Who Is on the Research Team?

Hugo Pereira, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for healthy individuals in two age groups: young adults aged 18-35 and older adults aged 65-90. It's not suitable for those with neuromuscular diseases or anyone who has metal implants or joint replacements.

Inclusion Criteria

I am healthy and aged 18-35 or 65-90.

Exclusion Criteria

I have a history of muscle or nerve diseases.

History of metal implants or joint replacement

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Familiarization

Participants undergo a familiarization session to get accustomed to the experimental procedures

1 session

1 visit (in-person)

Experimental Sessions

Participants engage in 3 randomized experimental sessions to assess force, anxiety levels, arterial pressure, and fatigue

3 sessions

3 visits (in-person)

Follow-up

Participants are monitored for any delayed effects or additional data collection after the experimental sessions

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Task

Trial Overview

The study is examining how performing a cognitive task can affect fatigue during muscle contractions, which might help understand the impact of aging on mental and physical performance.

How Is the Trial Designed?

Group I: young women Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group II: young men Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group III: older women Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Group IV: older men Experimental Treatment 1 Intervention

Individuals will participate in 1 familiarization and 3 test sessions

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

Published Research Related to This Trial

Cognitive rehabilitation (CR) has been identified as a potentially effective method for treating cognitive impairments, particularly memory and attention issues, in patients with epilepsy, based on a review of 18 studies.

A holistic approach to CR was found to be more beneficial than selective interventions, highlighting the importance of treatment modalities and outcome measures in clinical practice and research for epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation in epilepsy: An evidence-based review. Farina, E., Raglio, A., Giovagnoli, AR.[2022]

In a study of 103 brain-injured patients, over half (50.5%) were cleared to drive upon discharge, with better cognitive retraining performance linked to this driving clearance.

Factors such as effective cognitive retraining in areas like information processing and attention, along with strong working alliance scores with staff, were associated with improved chances of being cleared to drive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of cognitive retraining to neurological patients' driving status: the role of process variables and compensation training. Klonoff, PS., Olson, KC., Talley, MC., et al.[2019]

The RehaCom computerized cognitive training program significantly improved attention and memory functions in 50 brain injury patients after 60 training sessions, with all patients showing enhanced performance in the targeted areas.

The program was well-tolerated, with no reported negative effects such as mental fatigue, headache, or eye irritation, indicating its safety for use in rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. Fernández, E., Bringas, ML., Salazar, S., et al.[2022]

In a study involving 15 severely head-injured patients, computer-assisted training for attention and memory showed significant improvements in both computerized tasks and everyday behavior ratings after up to 20 hours of tailored exercises.

The training utilized the THINKable program, which effectively addressed individual needs, leading to measurable enhancements in attention and memory as assessed by psychometric measures and observer ratings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy study of THINKable in the attention and memory retraining of traumatically head-injured patients. Ruff, R., Mahaffey, R., Engel, J., 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]

Cognitive rehabilitation is a structured intervention that helps individuals recover cognitive skills after a brain injury, using tailored treatment plans based on thorough neuropsychological assessments.

It has been shown to be effective for a range of cognitive impairments, from mild to severe injuries, and can lead to significant improvements in cognitive abilities and overall psychosocial functioning at any time after the injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive rehabilitation following traumatic brain injury: assessment to treatment. Tsaousides, T., Gordon, WA.[2009]

Computerized cognitive training (CCT) shows strong evidence for improving processing speed in individuals with multiple sclerosis and moderate evidence for enhancing memory in both multiple sclerosis and brain tumor patients, based on a systematic review of 96 studies.

Despite the large number of studies on CCT, only 14 provided high-quality evidence (Level 1), and most outcomes focused on mental functions rather than activities or participation, suggesting a need for more comprehensive measures to assess the full impact of CCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computerised cognitive training in acquired brain injury: A systematic review of outcomes using the International Classification of Functioning (ICF). Sigmundsdottir, L., Longley, WA., Tate, RL.[2018]

In a study involving 62 patients with multiple sclerosis, a computer-assisted neuropsychological training program significantly improved cognitive functions such as verbal memory, working memory, and phonetic fluency over 3 months compared to a control group.

The training also led to a notable reduction in anxiety symptoms and an improvement in quality of life for the patients, highlighting its potential benefits beyond cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a short cognitive training program in patients with multiple sclerosis. Pérez-Martín, MY., González-Platas, M., Eguía-Del Río, P., et al.[2020]

In a study of 101 individuals with first-time traumatic brain injury (TBI), mental fatigue was found to significantly mediate the relationship between cognitive functions, specifically recognition memory and information processing speed, and the ability to return to productive activity.

Mental fatigue accounted for a notable portion of the impact of cognitive deficits on returning to work or daily activities, suggesting that addressing mental fatigue could be an important strategy in rehabilitation for TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mental fatigue mediates the relationship between cognitive functions and return to productive activity following traumatic brain injury: a mediation analysis. Chen, PY., Hsieh, SH., Lin, CK., et al.[2022]

Intellectual Function Training (IFT) is an occupational therapy method designed for cognitive retraining in patients with brain damage, focusing on enhancing various intellectual abilities such as visual perception, memory, and logical reasoning.

The IFT program involves systematic, individualized daily treatment over 2-4 months, utilizing comprehensive training materials based on neuropsychological and pedagogical principles to effectively remediate cognitive dysfunction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intellectual Function Training in adults with acquired brain damage. An occupational therapy method. Söderback, I., Normell, LA.[2006]

A follow-up study over 5.5 years showed that methylphenidate significantly improved mental fatigue, depression, anxiety, and processing speed in patients with mild traumatic brain injury (TBI), compared to those who did not receive the treatment.

Discontinuing methylphenidate led to a significant worsening of symptoms, indicating that ongoing treatment may be necessary for sustained improvement in cognitive function after TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Follow-up after 5.5 years of treatment with methylphenidate for mental fatigue and cognitive function after a mild traumatic brain injury. Johansson, B., Andréll, P., Rönnbäck, L., et al.[2021]

Transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex (DLPFC) significantly improved cognitive performance in multiple sclerosis (MS) patients by increasing P300 amplitude and reducing reaction times during cognitive tasks.

The study provides evidence that tDCS can effectively counteract cognitive fatigue in MS patients, suggesting it may be a promising therapeutic option for managing fatigue-related cognitive declines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrophysiological and behavioral effects of frontal transcranial direct current stimulation on cognitive fatigue in multiple sclerosis. Fiene, M., Rufener, KS., Kuehne, M., et al.[2018]

Cognitive remediation (CR) has been shown to effectively improve cognitive deficits in individuals with psychiatric disorders, which can enhance daily functioning and potentially influence the course of their illness.

To optimize CR interventions, it is recommended that they be engaging and motivating, utilize positive emotional stimuli, and connect training tasks to real-life situations, while also considering the potential positive effects on overall symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Remediation in Psychiatric Disorders: State of the Evidence, Future Perspectives, and Some Bold Ideas. Trapp, W., Heid, A., Röder, S., et al.[2022]

Cognitive training using the game 'Decoder' significantly improved sustained visual attention in 75 healthy young adults compared to control groups, as measured by the Cambridge Neuropsychological Test Automated Battery.

Participants who played Decoder reported higher enjoyment, motivation, and alertness, suggesting that this non-pharmacological approach could be beneficial for enhancing attention, potentially extending its use to individuals with attention-related disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in Attention Following Cognitive Training With the Novel "Decoder" Game on an iPad. Savulich, G., Thorp, E., Piercy, T., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3979126/

Cognitive training and cognitive rehabilitation for persons with ...

The single RCT of cognitive rehabilitation found promising results in relation to some patient and caregiver outcomes and was generally of high quality. The ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S1568163724001302

Effectiveness of Cognitive Stimulation Therapy (CST) for ...

The pooled results indicated that CST had a significant beneficial impact on global cognition, language, working memory, depression, neuropsychiatric symptoms, ...

3.

tandfonline.com

tandfonline.com/doi/full/10.1080/13607863.2024.2410256

Effectiveness of a 14-week protocol for cognitive ...

This pragmatic study shows that an adapted 14-week face-to-face CST protocol is effective in improving mental health in people with mild dementia.

4.

systematicreviewsjournal.biomedcentral.com

systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-022-02032-0

Efficacy of cognitive remediation on activities of daily living in ...

Cognitive remediation is effective in improving instrumental activities of daily living performance immediately post-intervention in older adults with mild ...

5.

cochranelibrary.com

cochranelibrary.com/cdsr/doi/10.1002/14651858.CD005562.pub3/abstract

Cognitive stimulation to improve cognitive functioning in ...

We found moderate‐quality evidence that overall CS made little or no difference to caregivers' mood or anxiety. We found a high level of ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12321626/

A systematic review and network meta-analysis - PMC

First network meta-analysis identifies reminiscence therapy (RT) as most effective cognitive training for global cognition across subjective ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165178117304511

Cognitive remediation training improves performance in ...

Formal cognitive exercise training led to improved self-reported and objectively-measured neurocognitive symptoms.

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8837877/

The Effects of Cognitive-Based Interventions in Older Adults

Meta-analysis showed that cognitive-based interventions were effective in improving the cognitive function (SMD=0.39, 95% CI=0.32–0.44) of older adults.

9.

research.aota.org

research.aota.org/ajot/article/73/Supplement_2/7312410010p1/6616/Cognition-Cognitive-Rehabilitation-and

Cognition, Cognitive Rehabilitation, and Occupational ...

This statement defines the role of occupational therapy in evaluating and addressing cognitive functioning to help clients maintain and improve occupational ...

10.

mdpi.com

mdpi.com/2076-3425/15/8/807

tDCS and Cognitive Training for Fatigued and ...

Conclusions: This study provides preliminary evidence for the potential benefits of integrating neuromodulation and cognitive rehabilitation as a personalized ...