Prehabilitation for Frailty

Recruiting at 1 trial location

Overseen By Dae Hyun Kim, MD, ScD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Non-English, Cognitive impairment, Chronic kidney, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this pilot study is to assess the feasibility of delivering a multicomponent prehabilitation and measuring patient-centered outcomes in older adults undergoing major surgery.

Research Team

Dae Hyun Kim, MD, ScD

Principal Investigator

Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215

Eligibility Criteria

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.

Inclusion Criteria

My frailty index is 0.25 or higher.

Patient provides an informed e-consent or remote consent

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

Exclusion Criteria

Patient is considered an inappropriate candidate per the surgeon's assessment

My surgery is planned within the next 3 weeks.

I have significant memory or thinking problems confirmed by a test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Prehabilitation

Participants undergo a multicomponent prehabilitation program including exercise, nutritional intervention, meditation, and cognitive behavioral intervention

3-4 weeks

Surgery

Participants undergo major elective abdominal, gynecological oncologic, urologic, or cardiovascular surgery

Follow-up

Participants are monitored for safety and effectiveness after surgery, with patient-centered outcomes measured at 30 and 90 days

3 months

Treatment Details

Interventions

• Cognitive Behavioral Intervention
• Exercise
• Meditation
• Nutrition

Trial Overview 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.

Participant Groups

Group I: Prehabilitation Experimental Treatment 4 Interventions

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

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Hebrew SeniorLife

Collaborator

Trials

52

Recruited

273,000+