Prehabilitation Interventions for Surgery Patients

Overseen By Carly Riedmann, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Children, MoCA score <23, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to help individuals prepare for surgery, aiming to improve recovery and reduce complications such as heart problems and memory issues afterward. Participants will engage in a combination of activities, including cognitive training (also known as computerized cognitive training or brain training), daily exercise, meditation, and social support, alongside standard surgical care. It targets individuals aged 65 and older who are at higher risk for complications after major heart or vascular surgeries and are scheduled for such procedures. Eligible participants should have experienced a stroke or transient ischemic attack (mini-stroke) that is fully resolved and have significant narrowing of the carotid artery. The trial aims to demonstrate that these pre-surgery activities can lead to better outcomes than usual care alone. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical recovery for many.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the treatments considered for this trial are generally safe and well-tolerated based on current data.

Cognitive training can enhance brain function and lower the risk of cognitive decline after surgery. Studies confirm its effectiveness and safety for surgical patients.

Meditation is low-risk. Although few studies focus on its safety, it is linked to reduced stress and better focus.

Daily exercise programs to prepare for surgery (prehabilitation) lead to positive outcomes, such as fewer complications. Research has found no negative effects, making it a safe choice.

Enhanced social support and personalized prehabilitation involve customized care before surgery to aid recovery. Recent studies show these methods are safe and help reduce surgery-related problems.

All these interventions are part of a prehabilitation approach, which aims to optimize patients' condition before surgery. Overall, they have been shown to be safe and effective in improving recovery and reducing risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a comprehensive approach to preparing patients for surgery, known as prehabilitation. Unlike standard pre-operative care, which typically focuses on medical assessments and risk reduction, this trial includes personalized interventions like cognitive training, meditation, daily exercise, and enhanced social support. These treatments aim to boost both mental and physical resilience before surgery, potentially leading to better recovery outcomes. Additionally, the trial investigates the benefits of optimizing intraoperative conditions, such as maintaining normal blood pressure and minimizing the use of deep anesthesia, which could reduce surgical risks. This holistic strategy is promising because it addresses multiple aspects of patient well-being, potentially setting a new standard for surgical preparation.

What evidence suggests that this trial's treatments could be effective for improving perioperative health?

Research has shown that preparing the mind and body before surgery can be beneficial. In this trial, participants in the intervention groups will engage in brain exercises, meditation, daily exercise, and enhanced social support. Brain exercises can reduce the risk of confusion or memory problems post-surgery. Meditation can lower stress and keep the mind sharp around the time of surgery. Exercise can improve fitness, making surgery safer and aiding faster recovery. Strong support from family and friends is linked to better health and quicker recovery after surgery. Combining these activities into a personalized plan, known as prehabilitation, has reduced complications and improved overall surgical outcomes. ^{2 6 7 8 9}

Who Is on the Research Team?

Senthilkumar Sadhasivam, MD, MPH, MBA

Principal Investigator

University of Pittsburgh

Amy Monroe, MPH, MBA

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 or older who are at higher risk of complications after major surgeries like heart bypass or vascular repairs. They must have a certain level of cognitive impairment and depression, expect to stay in the hospital for more than three days, and be able to give informed consent. All races, ethnicities, and educational backgrounds are welcome.

Inclusion Criteria

I am scheduled for a major heart or blood vessel surgery.

RAI score ≥ 30

PHQ-9 score ≥ 5

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Prehabilitation

Participants receive personalized prehabilitation with cognitive and behavioral interventions including physical exercise, cognitive training, meditation, and enhanced social support

4-6 weeks

Multiple visits (in-person and virtual)

Surgery and Intraoperative Monitoring

Participants undergo surgery with routine intraoperative SSEP and EEG monitoring, and proactive bundled interventions for eligible participants

1 day

1 visit (in-person)

Follow-up

Participants are monitored for cognitive outcomes, MACCE, and mortality at discharge, 1-, 3-, 6-, and 12-months post-surgery

12 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Cognitive Training
• Daily Exercise
• Enhanced Social Support
• Intra-operative Standard of Care
• Meditation
• Personalized CPC Prehabilitation
• Pre-operative Standard of Care

Trial Overview The study tests if pre-surgery preparation including meditation, personalized care plans (CPC), cognitive training, daily exercise, and enhanced social support can reduce death rates and improve recovery compared to standard care. It also aims to refine an algorithm predicting surgery risks related to Alzheimer's Disease.

How Is the Trial Designed?

Group I: Group B/D (SOC + proactive bundle interventions) Experimental Treatment 3 Interventions

Participants randomized to the control group in study Part I will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC. If eligible to continue to Study Part 2, participants who received standard of care pre-operatively, will receive Proactive Bundle Interventions during surgery that includes: Participants randomized to the proactive bundled intervention group (Group D) will receive a routine intraoperative SSEP and EEG monitoring as well as optimization of intraoperative physiology by maintaining normal blood pressure, oxygen levels, opioid sparing analgesia, avoiding deep anesthesia and benzodiazepines.

Group II: Group A/D (intervention + SOC) Experimental Treatment 8 Interventions

Participants randomized to this intervention group will receive the following interventions for study Part I: * Personalized CPC Prehabilitation * Cognitive Training * Meditation * Daily Exercise * Enhanced Social Support If eligible to continue to Study Part 2, participants who received the Part I intervention will receive standard of care monitoring that includes: Routine intraoperative SSEP and EEG monitoring.

Group III: Group A/C (intervention) Experimental Treatment 7 Interventions

Participants randomized to this intervention group will receive the following interventions: * Personalized CPC Prehabilitation * Cognitive Training * Meditation * Daily Exercise * Enhanced Social Support Additionally, they will undergo standard of care routine intraoperative SSEP and EEG monitoring during the scheduled surgery.

Group IV: Group B/C (SOC control) Active Control 2 Interventions

Participants randomized to the control group will receive standard of care pre-operative treatment, which may or may not include a visit to the CPC. Participants will receive standard of care routine intraoperative SSEP and EEG monitoring during the scheduled surgery.

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 144 middle-level managers, an 8-week mindfulness-based stress reduction (MBSR) program significantly reduced perceived work-related stress, negative affect, and sickness absence compared to a control group.

MBSR also improved self-esteem and positive affect among participants, indicating its effectiveness in enhancing psychological resilience in stressful work environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for managers: a randomized controlled study. Żołnierczyk-Zreda, D., Sanderson, M., Bedyńska, S.[2020]

Trainee clinical psychologists who participated in a modified Mindfulness-Based Cognitive Therapy (MBCT) program showed significant improvements, including decreased rumination and increased self-compassion and mindfulness, based on pre- and post-questionnaires from 20 participants.

The study found that more frequent home practice of mindfulness techniques led to greater reductions in stress and anxiety, and 85% of participants reported that the MBCT experience positively impacted their clinical work, enhancing their understanding of clients and themselves.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists. Rimes, KA., Wingrove, J.[2019]

Preoperative multimodal prehabilitation programs can enhance surgical outcomes by improving patients' nutritional, functional, and psychological states before surgery, which is especially important for the elderly and those with multiple health issues.

Evidence supports various preoperative interventions, such as exercise training and psychosocial support, but further research is needed to determine the most effective components and their ideal timing for optimal patient recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preparing the patient for surgery to improve outcomes. Levett, DZ., Edwards, M., Grocott, M., et al.[2022]

An abbreviated Mindfulness-Based Stress Reduction (MBSR) program consisting of 6 weekly 75-minute sessions can effectively be implemented during staff lunch breaks, making it a practical training option for healthcare providers and clinic staff.

This adapted MBSR program is not only feasible but also well-accepted, suggesting it could enhance the well-being of healthcare workers in a workplace setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction for Health Care Staff: Expanding Holistic Nursing Paradigms to the Whole System. Hazlett-Stevens, H.[2021]

Prehabilitation programs, which focus on improving physical condition, nutrition, and cognitive health, aim to reduce postoperative complications by optimizing patients from diagnosis to surgery.

These programs have synergistic effects, where small individual improvements combine to significantly enhance postoperative recovery, highlighting the need for their integration into routine clinical practice despite the need for more research on their impact across various patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Narrative Review About Prehabilitation in Surgery: Current Situation and Future Perspectives. López Rodríguez-Arias, F., Sánchez-Guillén, L., Armañanzas Ruiz, LI., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11486734/

Cognitive Prehabilitation for Older Adults Undergoing Surgery This review aimed to evaluate the effectiveness and safety of cognitive prehabilitation on cognitive functional capacity and postoperative cognitive outcomes

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S240545692300247X

Cognitive Prehabilitation: Counter Neurocognitive Frailty A recent meta-analysis of nine trials concluded that cognitive prehabilitation is potentially more effective in reducing POCD than POD [9]. However, trials that ...

3. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2772853

Effect of Cognitive Prehabilitation on the Incidence ... This randomized clinical trial examines whether cognitive prehabilitation reduces the incidence of postoperative delirium among older ...

4. jwatch.org jwatch.org/na58377/2025/02/11/does-prehabilitation-improve-surgical-outcomes

Does “Prehabilitation” Improve Surgical Outcomes? A meta-analysis suggests that it does, although evidence to support specific presurgical interventions is weak.

5. iars.org iars.org/2025-the-daily-dose/prepping-for-success/

Prepping for Success: Exercise, Nutrition, Cognitive Training ... cognitive prehabilitation, which involves brain training to enhance cognitive resilience before surgery. The latter is predicated on ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39430974/

Cognitive prehabilitation for older adults undergoing ... This review aimed to evaluate the effectiveness and safety of cognitive prehabilitation on cognitive functional capacity and postoperative cognitive outcomes

7. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2024.1474504/full

Cognitive prehabilitation for older adults undergoing ... This review aimed to evaluate the effectiveness and safety of cognitive prehabilitation on cognitive functional capacity and postoperative cognitive outcomes

8. journals.lww.com journals.lww.com/md-journal/fulltext/2024/11010/effects_of_cognitive_training_on_cognitive.26.aspx

Effects of cognitive training on cognitive function in patients ... The present study, based on a low to moderate quality of evidence, suggests that cognitive training improves cognitive functioning.

9. link.springer.com link.springer.com/article/10.1007/s44254-023-00014-6

Cognitive training in surgical patients: a systematic review ... Cognitive training (CT) has been shown to reduce the risk of postoperative cognitive dysfunction (POCD) in surgical patients undergoing general anesthesia.