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Prehabilitation for Frailty

N/A

Recruiting

Led By Dae Hyun M Kim, MD, ScD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

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

Must have

Patient is scheduled to have a gastrointestinal, gynecological oncologic, and urologic surgery

Patient's frailty index is ≥0.25

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial aims to see if it's possible to provide a pre-surgery program for older adults and measure how it affects their well-being before a major surgery.

Who is the study for?

This trial is for older adults who are frail (with a frailty index of 0.25 or higher) and scheduled for major gastrointestinal, gynecological oncologic, or urologic surgery. Participants must be able to give informed electronic or remote consent.Check my eligibility

What is being tested?

The study tests whether a combination of cognitive behavioral therapy, exercise routines, meditation practices, and nutritional planning can improve outcomes for patients before they undergo major elective surgeries.See study design

What are the potential side effects?

Since the interventions include non-invasive techniques like counseling, physical activity, relaxation exercises, and diet changes rather than medications or surgeries, significant side effects are not expected.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am scheduled for surgery related to my digestive, reproductive, or urinary system cancer.

Select...

My frailty index is 0.25 or higher.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 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

Feasibility of the prehabilitation program

Secondary outcome measures

Adherence to exercise

Adherence to meditation

Adherence to protein intake

+13 more

Other outcome measures

3-D Confusion Assessment Method

30-day mortality from all causes

30-day readmission from all causes

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: PrehabilitationExperimental Treatment4 Interventions

This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Meditation

2021

Completed Phase 3

~2740

Exercise

2016

Completed Phase 1

~760

Cognitive Behavioral Intervention

2010

Completed Phase 2

~1040

Nutrition

2011

Completed Phase 3

~58070

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Beth Israel Deaconess Medical CenterLead Sponsor

838 Previous Clinical Trials

13,010,462 Total Patients Enrolled

1 Trials studying Frailty

800 Patients Enrolled for Frailty

Hebrew SeniorLifeOTHER

46 Previous Clinical Trials

270,739 Total Patients Enrolled

2 Trials studying Frailty

166 Patients Enrolled for Frailty

Dae Hyun M Kim, MD, ScDPrincipal InvestigatorBeth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215

Frequently Asked Questions

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

Are new participants still being enrolled in this clinical trial?

"Indeed, the details on clinicaltrials.gov reveal that recruitment is ongoing for this investigation. The trial was first listed on March 27th, 2023 and underwent its most recent update on February 4th, 2024. They aim to enlist a total of 30 individuals at one designated site."

Answered by AI

What is the current participation count in this clinical trial?

"Indeed, data from clinicaltrials.gov indicates that this study is actively seeking participants. It was initially posted on March 27th, 2023 and last modified on February 4th, 2024. The trial aims to recruit a total of 30 individuals at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Multi-Component Prehabilitation for Major Elective Surgery

Dae Hyun Kim 2023. "Multi-Component Prehabilitation for Major Elective Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05752474.