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

Trial Summary

What is the purpose of this trial?

The COgnitive and Physical Exercise to improve Outcomes after Surgery (COPE-iOS) study is testing the hypothesis that a pragmatic program combining computerized cognitive training and physical training throughout the perioperative period will improve long-term cognitive and disability outcomes in older surgical patients at high risk for decline. To accomplish these goals, the Investigators are randomizing 250 patients ≥60 years old undergoing elective major non-cardiac surgery with expected hospitalization ≥3 days to a pragmatic comprehensive training program (computerized cognitive training and supervised progressive physical exercise) or to active control (control computer game, stretching exercises) for 2-4 weeks prior to surgery and for 3 months after discharge. At baseline and after discharge, the Investigators will assess global cognition, activities of daily living, depression, endothelial and blood brain barrier function (blood biomarkers), and neuroimaging (anatomical and functional MRI). In this early stage trial, the Investigators will determine if certain subgroups benefit most, program aspects with greatest effect on outcomes, mechanistic associations with outcomes, and additional exploratory analyses.

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 this treatment for surgery recovery?

Research shows that psychoeducational care, which is part of the treatment, helps reduce recovery time, pain, and psychological distress after surgery. Additionally, visual and auditory interventions can improve gastrointestinal function and reduce complications, suggesting that similar components in the program may aid recovery. ^{1 2 3 4 5}

Is the Comprehensive Training Program for Surgery Recovery safe for humans?

Research shows that psychoeducational care, which is part of the Comprehensive Training Program, is generally safe and can help reduce pain and anxiety after surgery. It has been used successfully in various surgical settings, including spinal and thoracic surgeries, without reported safety concerns. ^{1 2 6 7 8}

How is the Comprehensive Training Program for Surgery Recovery different from other treatments?

The Comprehensive Training Program for Surgery Recovery is unique because it combines education about pain, cognitive training, and physical exercise to help patients recover after surgery. This approach not only addresses physical recovery but also focuses on improving cognitive function and emotional coping, which can lead to better overall recovery outcomes compared to traditional methods that may not include these elements. ^{1 8 9 10 11}

Research Team

Christopher G Hughes, MD

Principal Investigator

Vanderbilt University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

1. Hungary pubmed.ncbi.nlm.nih.gov

[The effect of surgical psychoeducation on the outcome of spinal surgery]. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

Auditory and Visual Stimulation for Abdominal Postoperative Patients Experiencing Enhanced Recovery After Surgery (ERAS). [2022]

5. Italy 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]. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Client-nurse interaction: testing for its impact in preoperative instruction. [2019]

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

Combination Treatment of Perioperative Rehabilitation and Psychoeducation Undergoing Thoracic Surgery. [2020]

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

Prevention of Early Postoperative Decline: A Randomized, Controlled Feasibility Trial of Perioperative Cognitive Training. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

[Psychological prophylaxis training for coping with postoperative pain. Long-term effects]. [2021]

10. Croatia pubmed.ncbi.nlm.nih.gov

[Preoperative preparation and the quality of postoperative recovery in surgery patients: an experimental study]. [2009]

11. England pubmed.ncbi.nlm.nih.gov

Decreasing postoperative cognitive deficits after heart surgery: protocol for a randomized controlled trial on cognitive training. [2020]