Cycle + Cognitive Training for Delirium

Recruiting at 1 trial location

Overseen By Matthew S Chrisman, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri, Kansas City

Must not be taking: Chemotherapy

Disqualifiers: Cancer, Neurodegenerative diseases, Alcohol, others

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

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of cycling and brain exercises, known as Simultaneous Cycle/Cognitive Training, can improve thinking skills and quality of life for individuals who experienced delirium (a state of confusion) after an ICU stay. Participants will either engage in this combined activity or continue with their usual care. The trial targets middle-aged individuals who have experienced at least one delirium episode during their ICU stay and have been discharged home. Researchers will assess the practicality and enjoyment of this combined approach for participants. This could lead to better methods for helping ICU survivors recover mentally and physically. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery strategies for ICU survivors.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this simultaneous recumbent cycling and cognitive training is safe for middle-aged ICU survivors?

Research has shown that combining physical exercise with brain training can improve thinking skills. However, limited information exists on the safety of simultaneously performing cycling and brain exercises for individuals who have been in the ICU.

In similar studies, participants engaged in aerobic exercises while completing brain tasks without major safety issues. These activities were generally well-tolerated, with only minor problems reported, such as muscle soreness or tiredness, which are common with any exercise.

This suggests that the treatment could be safe for ICU survivors, but individual health considerations are important. Participants should consult their doctors before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the simultaneous cycle/cognitive training for delirium because it combines physical and mental exercises in a novel way. Unlike standard treatments that primarily focus on medication and supportive care, this approach involves patients participating in recumbent cycling while engaging in cognitive tasks on a tablet. This dual-action method may enhance cognitive recovery by stimulating both the body and mind, potentially offering a more holistic and effective way to manage delirium symptoms after hospital discharge.

What evidence suggests that Simultaneous Cycle/Cognitive Training is effective for improving cognition and quality of life in ICU survivors?

Research shows that combining physical exercise with mental activities can improve brain function. Studies have found that doing both simultaneously, such as cycling while solving puzzles, boosts brain power more than doing each separately. One study discovered that people experienced better thinking skills after just one session of this dual-task exercise. In this trial, participants in the Simultaneous Cycle/Cognitive Training arm will engage in recumbent cycling with simultaneous cognitive training on a tablet after discharge from the hospital. This combined approach may help clear the minds of ICU survivors, who often experience confused thinking, and prevent further decline. Cycling gets the body moving, while mental tasks keep the brain active, which together can improve overall brain health. ^{1 2 4 6 7}

Who Is on the Research Team?

Rita S Lasiter, PhD

Principal Investigator

University of Missouri, Kansas City

Matthew S Chrisman, PhD

Principal Investigator

University of Missouri, Kansas City

Are You a Good Fit for This Trial?

This trial is for middle-aged (45-64 years) ICU survivors who had at least one delirium episode during their stay. Participants must have been in the ICU for over 24 hours, speak English, be discharged home, able to consent, and have telephone access.

Inclusion Criteria

I have been in the ICU for more than a day.

Access to a telephone

English-speaking

Exclusion Criteria

I am experiencing memory or thinking problems after chemotherapy.

Examiner rated low hearing or communicative ability that would interfere with intervention and assessments

Documented alcohol consumption ≥5 drinks/day (withdrawal delirium tremens)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants engage in 12 weeks of simultaneous recumbent cycling and cognitive training

12 weeks

Regular sessions at rehabilitation centers

Maintenance

No intervention delivered; participants maintain activities independently

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Assessments at 12, 24, and 36 weeks post-baseline

What Are the Treatments Tested in This Trial?

Interventions

• Simultaneous Cycle/Cognitive Training

Trial Overview The study tests a new therapy combining recumbent cycling with cognitive exercises for improving cognition and quality of life in middle-aged patients post-ICU delirium. It measures how feasible and acceptable this simultaneous exercise-cognitive training is when done in rehabilitation centers.

How Is the Trial Designed?

Group I: Simultaneous Cycle/Cognitive Training Experimental Treatment 1 Intervention

After discharge from the hospital the group will engage in recumbent cycling with simultaneous cognitive training on a tablet.

Group II: Usual Care Active Control 1 Intervention

After discharge from the hospital the group will complete baseline activies.

Who Is Running the Clinical Trial?

University of Missouri, Kansas City

Lead Sponsor

Trials

73

Recruited

34,600+

American Association of Critical Care Nurses

Collaborator

Trials

4

Recruited

180+

Truman Medical Center

Collaborator

Trials

10

Recruited

301,000+

St. Luke's Hospital, Kansas City, Missouri

Collaborator

Trials

9

Recruited

12,500+

American Association of Critical-Care Nurses

Collaborator

Trials

3

Recruited

180+

Published Research Related to This Trial

A study involving 21 adults with very mild or mild Alzheimer's disease showed that intensive cognitive training (4 to 5 hours daily for 10 days) led to significant improvements in tasks related to working memory and attention.

Participants maintained their cognitive gains, as measured by the Mini-Mental State Examination and other tests, even 2 to 4 months after the training, suggesting that intensive cognitive training can be beneficial for early-stage Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of intensive cognitive training in early-stage Alzheimer's disease. Kanaan, SF., McDowd, JM., Colgrove, Y., et al.[2015]

Aerobic training significantly improved cognitive function in cancer patients, with notable increases in logical memory, delayed recall, block design, and letter-number sequencing scores after a 12-week intervention involving 36 sessions.

Combined aerobic and cognitive training did not yield improvements in cognitive scores, suggesting that while aerobic exercise is beneficial, the combination may be too challenging for patients undergoing cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a combined aerobic and cognitive training intervention on cognitive function in cancer survivors: a pilot investigation. Peterson, BM., Johnson, C., Case, KR., et al.[2022]

Cytotoxic drugs used for treating non-CNS tumors may lead to cognitive side effects, highlighting the need for more research to understand these impacts better.

The International Cognition and Cancer Task Force has established recommendations for standardized neuropsychological tests and criteria to assess cognitive impairment, which will enhance the quality and comparability of future studies on chemotherapy-related cognitive issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. Wefel, JS., Vardy, J., Ahles, T., et al.[2022]

Memory and attention adaptation training (MAAT) is a cognitive-behavioral therapy that has been shown to improve symptoms of cancer-related cognitive impairment (CRCI) and enhance the quality of life for cancer survivors.

The article proposes a single-case experimental design (SCED) approach to evaluate the effectiveness of MAAT in clinical settings, which can help in continuously assessing and improving treatments for CRCI as the number of cancer survivors increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Single-Case Experimental Design and Patient-Reported Outcome Measures to Evaluate the Treatment of Cancer-Related Cognitive Impairment in Clinical Practice. Ferguson, RJ., Terhorst, L., Gibbons, B., et al.[2023]

Cancer-related cognitive impairment (CRCI) is increasingly recognized in cancer patients outside the central nervous system, highlighting the need for targeted interventions to improve cognitive function and quality of life.

The paper emphasizes the importance of multidisciplinary research efforts in Europe to address challenges such as data sharing, standardization of assessments, and the exploration of biomarkers and neuroimaging to develop effective cognitive intervention programs for CRCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-related cognitive impairment in non-CNS cancer patients: Targeted review and future action plans in Europe. Sleurs, C., Amidi, A., Wu, LM., et al.[2022]

Combining medications with cognitive training may provide greater benefits for nondemented adults with cognitive impairment than using either approach alone, addressing a significant gap in treatment options for this population.

Current cognitive training techniques are often ineffective for many older adults with cognitive issues, highlighting the need for further research into effective medications and their administration alongside cognitive interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Should one use medications in combination with cognitive training? If so, which ones? Yesavage, J., Hoblyn, J., Friedman, L., et al.[2019]

The ACTIVATE trial is investigating the effects of supervised aerobic exercise on cognitive changes related to chemotherapy in women with breast cancer, aiming to determine if exercise can prevent or manage these cognitive issues during treatment.

This randomized controlled trial will assess cognitive functioning and quality of life at multiple points during and after chemotherapy, potentially supporting aerobic exercise as a beneficial intervention for women experiencing chemotherapy-related cognitive changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol of the Aerobic exercise and CogniTIVe functioning in women with breAsT cancEr (ACTIVATE) trial: a two-arm, two-centre randomized controlled trial. Brunet, J., Barrett-Bernstein, M., Zadravec, K., et al.[2021]

A six-week psychoeducation-based group cognitive rehabilitation intervention for cancer-related cognitive impairment (CRCI) showed significant improvements in self-reported cognitive function and health-related quality of life (HRQOL) among participants.

Out of 110 participants, 85 completed the assessments, and the positive effects on cognitive function and HRQOL were sustained over time, indicating the intervention's effectiveness and high participant satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cancer-Related Cognitive Impairment: Retrospective Analyses of a Multidimensional, Psychoeducation-Based Cognitive Rehabilitation Intervention. Asher, A., Van Dyk, K., Jo, MY., et al.[2023]

A 9-week study involving 84 older adults with Subjective Cognitive Decline (SCD) and Mild Cognitive Impairment (MCI) found that Computerized Cognitive Training (CCT) significantly improved cognitive functions, particularly in areas like verbal fluency and memory.

Combining CCT with Whole Body Stimulation (WBC) not only enhanced cognitive performance but also significantly reduced depressive symptoms, suggesting this combined approach could be a beneficial non-pharmacological intervention for older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Computerized Cognitive Training Combined With Whole Body Cryotherapy in Improving Cognitive Functions in Older Adults. A Case Control Study. Senczyszyn, A., Wallner, R., Szczesniak, DM., et al.[2023]

Chemotherapy-related neurocognitive impairment (CRCI) is a significant issue for breast cancer survivors, affecting about 22% of the 11 million cancer survivors in the USA, and currently, there are no established treatments for it.

Multimodal interventions that combine nutrient-derived bioactive compounds with antioxidant and anti-inflammatory properties, along with cognitive training and exercise, may help reduce inflammation and oxidative stress, leading to improved cognitive function and quality of life for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Promise of Nutrient-Derived Bioactive Compounds and Dietary Components to Ameliorate Symptoms of Chemotherapy-Related Cognitive Impairment in Breast Cancer Survivors. Kumar, NB.[2022]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04556227

Simultaneous Recumbent Cycling and Cognitive Training Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts ...

2. withpower.com withpower.com/trial/phase-delirium-2021-fb846

Cycle + Cognitive Training for Delirium Simultaneous Cycle/Cognitive Training is unique because it combines physical exercise (cycling) with cognitive training, which may enhance cognitive function ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8983262/

Simultaneous Dual-Task Interventions That Improve Cognition ... The effectiveness timeframe varied significantly between studies; for example, cognitive improvements were observed after one session of ...

4. newswise.com newswise.com/articles/aacn-funded-research-influences-nursing-practice

AACN-funded Research Influences Nursing Practice Simultaneous Recumbent Cycling and Cognitive Training on Cognition in ICU Survivors: A Randomized Control Trial (Impact Research Grant): Many ICU survivors ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02963415

Concurrent Aerobic Exercise and Virtual Reality Cognitive ... The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7052975/

Effects of simultaneous cognitive and aerobic exercise ... Here, we present results of a pilot randomized controlled trial (RCT) to evaluate the effects of a simultaneous aerobic exercise and cognitive ...

7. withpower.com withpower.com/clinical-trials/for-dementia?new=true&page=1

Top Dementia Clinical Trials | Power Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU ...