Comprehensive Training Program for Surgery Recovery

(COPEiOS Trial)

Overseen By Christopher G Hughes, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Vanderbilt University Medical Center

Disqualifiers: Blind, deaf, dementia, others

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

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a combination of brain games and physical exercises can improve thinking skills and daily functioning in older adults undergoing major surgery. Participants will either engage in a comprehensive training program with brain and physical exercises, known as the COPE-iOS Program, or follow a simpler routine with basic computer games and stretches, referred to as the active control. It targets individuals aged 60 and older who are scheduled for significant surgeries and will remain in the hospital for at least three days. As an unphased trial, this study provides participants the opportunity to contribute to innovative research that could enhance recovery and quality of life after surgery.

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 comprehensive training program is safe for older surgical patients?

Research shows that the training program under study is generally easy for people to handle. This program includes both mental exercises and physical activities. Previous studies with similar programs have found that older adults can safely complete them. One study found that a 12-week program improved brain function and efficiency in older adults, indicating that participants managed it well without major problems.

No reports of serious side effects have emerged from the brain games or physical exercises involved. This suggests the program is safe for participants, even those over 60 years old who are having surgery. However, since this is a new study, participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Training Program for Surgery Recovery because it combines computerized brain games with online interactive physical exercises, offering a holistic approach to recovery. Unlike traditional rehabilitation that mainly focuses on physical therapy, this program aims to enhance both cognitive and physical recovery, which could lead to faster and more comprehensive healing. By integrating mental exercises with physical ones, this method may improve overall brain function and physical endurance, potentially resulting in better outcomes for patients recovering from surgery.

What evidence suggests that this comprehensive training program is effective for improving surgery recovery?

Research shows that a training program combining mental and physical exercises may help older surgical patients recover better. In this trial, participants in the intervention arm will receive a comprehensive training program that includes computerized brain game training and online interactive physical exercise training. A review of 191 studies has found that programs like this, which include educational and psychological support, significantly help surgical patients by improving recovery and reducing complications. Mental exercises have effectively enhanced brain function, which is important for patients recovering from surgery. Additionally, physical training before surgery has been linked to better mental outcomes afterward. These findings suggest that combining mental and physical exercises could lead to better recovery and long-term benefits for patients undergoing major surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Christopher G Hughes, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

The COPE-iOS study is for individuals aged 60 or older who are scheduled for elective major non-cardiac surgery with a hospital stay of at least 3 days. Participants must be able to consent, use a tablet or laptop, and understand English. Those with severe frailty, cognitive impairment preventing self-consent, or enrolled in similar trials cannot join.

Inclusion Criteria

I am scheduled for a major surgery that is not heart-related and will be in the hospital for 3 or more days.

I am 60 years old or older.

Exclusion Criteria

Co-enrolled in another interventional trial examining similar outcomes or current enrollment in a study that does not allow co-enrollment

I am too frail or physically impaired to participate in the program.

Prisoners

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-surgery Training

Participants undergo computerized cognitive training and supervised progressive physical exercise or control activities for 2-4 weeks prior to surgery

2-4 weeks

Post-surgery Training

Participants continue with cognitive and physical training or control activities for 3 months after discharge

3 months

Follow-up

Participants are monitored for cognitive and functional outcomes, including global cognition, activities of daily living, and depression

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Active control
• Comprehensive training program

Trial Overview This trial tests if combining computerized brain exercises and physical training before and after surgery can improve long-term mental function and reduce disability in older patients. Half will receive the comprehensive program while the other half gets control activities like simple games and stretching.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Computerized brain game training and online interactive physical exercise training

Group II: Control Active Control 1 Intervention

Control computer games and online interactive stretching exercises.

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

The combination of perioperative rehabilitation and psychoeducation effectively improved adaptive thinking and increased physical activity in two cancer patients undergoing thoracic surgery, leading to favorable recovery outcomes without pulmonary complications.

This case series suggests that addressing negative automatic thoughts through psychoeducation can enhance the rehabilitation process for cancer patients, indicating a potential new approach to improve postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Treatment of Perioperative Rehabilitation and Psychoeducation Undergoing Thoracic Surgery. Hayashi, K., Inoue, T., Nagaya, M., et al.[2020]

A randomized controlled trial involving 45 older adults undergoing cardiac surgery explored the feasibility of a cognitive training (CT) program, showing a 65% enrollment rate but varied adherence levels, with a median adherence of only 39% during the preoperative period.

While the CT program did not significantly reduce the incidence of postoperative delirium or cognitive dysfunction compared to usual care, participants reported improvements in their perceived memory and thinking abilities, suggesting potential benefits that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of Early Postoperative Decline: A Randomized, Controlled Feasibility Trial of Perioperative Cognitive Training. O'Gara, BP., Mueller, A., Gasangwa, DVI., et al.[2023]

In a study of 48 young male patients undergoing surgery for chest malformation, those who received multidimensional psychological prophylaxis training showed significantly better recovery outcomes, including reduced acute pain intensity and pain disability, compared to a control group.

The training, which focused on coping with cognitive-emotional pain, helped lower pain anxiety even 12 months post-surgery, suggesting it serves as a protective factor against long-term pain management issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Psychological prophylaxis training for coping with postoperative pain. Long-term effects]. Scheel, J., Parthum, A., Dimova, V., et al.[2021]

Individualized patient education interventions significantly reduce hospital readmission rates, depression, and anxiety in patients recovering from cardiovascular surgery, based on a systematic review of 17 trials involving 2624 participants.

These interventions also improve the performance of specific health behaviors and cognitive function, indicating a positive impact on overall recovery and quality of life post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of individual patient education in heart surgery patients: A systematic review and meta-analysis. Fredericks, S., Yau, T.[2018]

Psychoeducation before spinal surgery significantly reduces the consumption of postoperative analgesics, indicating that informed patients may experience less pain after surgery.

Involving a psychologist in surgical care not only enhances patients' physical and mental recovery but also lowers rehabilitation costs, highlighting the importance of addressing patients' fears and anxieties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effect of surgical psychoeducation on the outcome of spinal surgery]. Sütő, J., Klekner, Á., Nagy, J., et al.[2023]

A meta-analysis of 191 studies found that psychoeducational care significantly benefits adult surgical patients by improving recovery, reducing postoperative pain, and alleviating psychological distress.

The positive effects of psychoeducational care were confirmed to be reliable and not influenced by publication bias or other methodological issues, indicating its continued relevance in modern clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of psychoeducational care for adult surgical patients: a meta-analysis of 191 studies. Devine, EC.[2019]

The study found that visual and auditory interventions significantly improved gastrointestinal function in patients after abdominal surgery, leading to increased bowel sound frequency and shorter time until the first anal self-exsufflation.

Patients who underwent laparoscopic cholecystectomy and radical gastrectomy benefited from auditory interventions, while those with colon cancer showed improvements with both auditory and visual stimulation, suggesting these interventions can enhance recovery and reduce hospital stays.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory and Visual Stimulation for Abdominal Postoperative Patients Experiencing Enhanced Recovery After Surgery (ERAS). Lu, J., Tao, P., Li, H., et al.[2022]

A training program and pain management protocol significantly reduced pain intensity in surgical ICU patients, with notable decreases in pain scores at 6, 12, and 48 hours post-surgery, indicating improved pain management practices.

Patients who received the intervention required less morphine and propofol, suggesting that the training program not only alleviated pain but also optimized medication use, although further studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The effects of a clinical therapeutic intervention in pain assessment and management in surgical ICU patients: a before-and-after intervention study on pain intensity and use of analgesia]. Damico, V., Murano, L., Manzoni, L., et al.[2021]

In a study of 91 cholecystectomy patients, those who received either the Facilitator or Informational intervention reported significantly less postoperative anxiety compared to those who received routine treatment.

There were no significant differences in pain scores among the three intervention groups, suggesting that while client-nurse interaction can reduce anxiety, it may not directly impact pain levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Client-nurse interaction: testing for its impact in preoperative instruction. Schwartz-Barcott, D., Fortin, JD., Kim, HS.[2019]

An educational program for surgical patients, involving 32 patients undergoing cholecystectomy, significantly improved their psychophysiological condition and reduced anxiety compared to a control group.

Patients who received education about pain control and coping skills experienced a quicker and higher quality recovery in the 5 days following surgery, highlighting the importance of patient education in surgical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Preoperative preparation and the quality of postoperative recovery in surgery patients: an experimental study]. Barath, A., Havelka, M., Gavrilo, P.[2009]

This study will assess the effectiveness of early postoperative cognitive training in reducing cognitive deficits in 144 elderly patients undergoing heart-valve surgery, with training starting about a week after surgery and lasting for 18 days.

The primary goal is to evaluate improvements in objective cognitive functions at discharge from rehabilitation, while secondary outcomes will include long-term effects on cognitive functions, depression, and quality of life, potentially leading to better rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training. Butz, M., El Shazly, J., Sammer, G., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04889417

COgnitive and Physical Exercise to Improve Outcomes ... The COPE-iOS program is a pragmatic comprehensive training program that combines computerized cognitive training and progressive supervised ...

2. withpower.com withpower.com/trial/phase-cognitive-dysfunction-8-2021-63d94?condition=Surgery&overallStatus=Recruiting&hasNoPlacebo=false

Comprehensive Training Program for Surgery Recovery A meta-analysis of 191 studies found that psychoeducational care significantly benefits adult surgical patients by improving recovery, reducing postoperative ...

3. icudelirium.org icudelirium.org/projects/cope-ios

COPE-iOS A study of the effects of brain training and physical exercise on recovery after major surgery.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03094988

COgnitive and Physical Exercise (COPE) Prehabilitation ... Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11614964/

The effect of pre-operative exercise training on post ... Preoperative physical training may improve post-operative cognitive function, although more research with a consistent endpoint is required.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10515553/

Effects of computer-based cognitive training combined with ... A 12-week physical and cognitive exercise program can improve cognitive function and neural efficiency in community-dwelling older adults: a ...