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

1200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will contribute to creating a prospective and robust automated preoperative risk assessment algorithm for 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE) and perioperative neurocognitive disorders (PND) outcomes following elective general, orthopedic, cardiac, or vascular surgery. It will help to identify correlations between perioperative factors and Alzheimer's Disease (AD) or AD-related dementias (ADRD). Lastly, this study will create effective, validated multi-modal interventions to improve perioperative health. This study will explore two main hypotheses: 1. Preoperative prehabilitation and proactive cognitive/behavioral interventions will effectively improve postoperative cognitive outcomes, morbidities, and mortality, and; 2. The proactive bundled interventions are superior to current standard of care in reducing postoperative cognitive outcomes, MACCE and mortality. Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.

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 prehabilitation, including mindfulness-based stress reduction, safe for humans?

Mindfulness-based stress reduction (MBSR) has been used safely in various settings, including for healthcare staff and managers, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How does prehabilitation differ from other treatments for surgery patients?

Prehabilitation is unique because it focuses on preparing patients for surgery by improving their physical fitness, nutrition, and mental well-being before the procedure, unlike traditional approaches that focus mainly on the surgery itself. This proactive approach aims to reduce postoperative complications and enhance recovery by addressing multiple aspects of a patient's health before surgery. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Prehabilitation Interventions for Surgery Patients?

Research suggests that preoperative mindfulness-based stress reduction (MBSR) can improve outcomes for patients undergoing lumbar spine surgery, and cognitive prehabilitation may help reduce the risk of cognitive decline after surgery in older adults. Additionally, multimodal prehabilitation programs, which include exercise and psychosocial support, have been shown to improve surgical outcomes and facilitate recovery. ^{6 8 11 12 13}

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

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]

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]

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]

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]

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

The Impact of Preoperative Mindfulness-Based Stress Reduction on Postoperative Outcomes in Lumbar Spine Degenerative Disease: 3-Month and 12-Month Results of a Pilot Study. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive Prehabilitation: How Can We Counter Neurocognitive Frailty? [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The P3-model of perioperative psychological preparation: Pre-surgical and pre-medical procedural psychological preparation and psychophysiological interventions. [2022]

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

Psychological interventions in the pre-surgical period. [2019]

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

Preparing the patient for surgery to improve outcomes. [2022]

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

Mindfulness-based stress reduction training yields improvements in well-being and rates of perceived nursing errors among hospital nurses. [2019]

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

Effect of a behavioral intervention on anxiety and perceived performance of non-technical skills during surgical simulations. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for managers: a randomized controlled study. [2020]

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

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

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

Pilot study of Mindfulness-Based Cognitive Therapy for trainee clinical psychologists. [2019]

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

Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. [2019]

12. Spain pubmed.ncbi.nlm.nih.gov

A Narrative Review About Prehabilitation in Surgery: Current Situation and Future Perspectives. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Socioeconomic status influences participation in cancer prehabilitation and preparation for surgical recovery: A pooled retrospective analysis using a validated area-level socioeconomic status metric. [2023]