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

Trial Summary

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 data supports the effectiveness of the treatment Simultaneous Cycle/Cognitive Training, Simultaneous Recumbent Cycling and Cognitive Training, SRCCT?

Research suggests that aerobic exercise and cognitive training, when used separately, can improve cognitive function in cancer patients. Combining these approaches may offer a promising way to help manage cognitive changes related to cancer treatment. ^{1 2 3 4 5}

Is Simultaneous Cycle/Cognitive Training safe for humans?

The research articles provided do not contain specific safety data for Simultaneous Cycle/Cognitive Training or its variations. Therefore, no relevant safety information is available from these sources. ^{1 2 6 7 8}

How is the Simultaneous Cycle/Cognitive Training treatment different from other treatments for delirium?

Simultaneous Cycle/Cognitive Training is unique because it combines physical exercise (cycling) with cognitive training, which may enhance cognitive function more effectively than either approach alone. This dual approach is not commonly used in standard delirium treatments, which often focus on medication or single-modality therapies. ^{1 2 9 10 11}

What is the purpose of this trial?

Intensive care units (ICU) provide life-saving care for nearly five million people annually. Up to 80% of patients receiving care in an ICU experience at least one episode of delirium. Delirium, an acute episodic display of confused thinking and unawareness, predicts impaired cognition and accelerated cognitive decline which negatively impacts quality of life (QOL) long after hospital discharge. The average age of ICU patients is 52 years. These middle-age (MA) ICU survivors need cognitive interventions that are well planned, accessible, and effective to improve cognition and prevent accelerated decline so they can resume their previous QOL and enter older age with optimized cognitive function. Physical exercise and cognitive training independently improve cognition and emerging evidence indicates that combining these two approaches produces even greater effects on cognition. Community-based rehabilitation centers are accessible for MAICU survivors to engage in physical activity; cognitive training could easily be added. Approaches in which a patient engages in physical exercise and cognitive training concurrently is an understudied intervention for all ICU survivors, especially those who are middle-aged. Study aims are to investigate the feasibility and acceptability of a simultaneous recumbent cycling and cognitive training intervention (SRCCT) for MAICU survivors who experienced at least one delirium episode during their ICU stay. Feasibility will be determined by systematically evaluating research team training, participant recruitment, randomization, implementation, and intervention fidelity. Acceptability will be evaluated via a satisfaction, preferences, burden, and participant-suggested improvements survey. The SRCCT effect sizes will be calculated comparing multiple data point cognition scores between an SRCCT group and a usual care control group. Upon completion, investigators expect to understand the feasibility and acceptability of the SRCCT delivered in community-based rehabilitation centers, and the combined effect of SRCCT on cognition and QOL for middle-aged ICU survivors who experienced an episode of ICU delirium. The hypothesis is that study participants who engage in physical exercise and cognitive training concurrently will have a greater improvement in cognition and QOL than physical exercise training alone.

Research Team

Rita S Lasiter, PhD

Principal Investigator

University of Missouri, Kansas City

Matthew S Chrisman, PhD

Principal Investigator

University of Missouri, Kansas City

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Feasibility of a combined aerobic and cognitive training intervention on cognitive function in cancer survivors: a pilot investigation. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Cancer-Related Cognitive Impairment: Retrospective Analyses of a Multidimensional, Psychoeducation-Based Cognitive Rehabilitation Intervention. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Effect of cognitive training on patients with breast cancer reporting cognitive changes: a systematic review and meta-analysis. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Cancer-related cognitive impairment in non-CNS cancer patients: Targeted review and future action plans in Europe. [2022]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

International Cognition and Cancer Task Force recommendations to harmonise studies of cognitive function in patients with cancer. [2022]

8. Switzerland 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Feasibility and efficacy of intensive cognitive training in early-stage Alzheimer's disease. [2015]

10. United States pubmed.ncbi.nlm.nih.gov

Should one use medications in combination with cognitive training? If so, which ones? [2019]

11. Switzerland 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. [2023]