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Prehabilitation Interventions for Surgery Patients

N/A

Waitlist Available

Led By Senthilkumar Sadhasivam, MD, MPH, MBA

Research Sponsored by University of Pittsburgh

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for major cardiac surgeries including coronary artery bypass and valvular repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm repair, and major vascular surgeries

65 years of age and older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative 12-months

Awards & highlights

Study Summary

This trial will create an algorithm to predict 30-day mortality, major cardiac & cerebrovascular events, and Alzheimer's Disease-related dementia following surgery, plus effective interventions to improve post-op health. Outcome: more accurate EHR prediction & improved post-op cognitive outcomes.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-invasive interventions like meditation and exercise rather than medications, side effects may include discomfort or fatigue from new activities but are generally expected to be minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 65 years old or older.

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I speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative 12-months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cognitive Outcomes - Cognitive Function

Cognitive Outcomes - Delirium

Cognitive Outcomes - Dementia

Secondary outcome measures

Cognitive Outcomes - Depression

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Group B/D (SOC + proactive bundle interventions)Experimental Treatment3 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 Treatment8 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 Treatment7 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 Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation

2021

Completed Phase 3

~2740

Daily Exercise

2016

N/A

~30

Cognitive Training

2008

Completed Phase 3

~4100

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor

1,723 Previous Clinical Trials

16,341,956 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,701 Previous Clinical Trials

7,505,650 Total Patients Enrolled

Amy Monroe, MPH, MBAStudy DirectorUniversity of Pittsburgh

3 Previous Clinical Trials

435 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still vacancies available for this research endeavor?

"The clinicaltrials.gov page confirms that this research project, initially posted on October 31st 2023 and last updated in September 13th of the same year, is no longer recruiting patients. Nonetheless, there are currently 544 other studies searching for participants to join their trials."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prediction and Prevention of Postoperative Mortality and Morbidity

Senthil Sadhasivam 2024. "Prediction and Prevention of Postoperative Mortality and Morbidity". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06042413.