Implementation of a Prehabilitation Program for Surgical Patients

NCT ID: NCT05377970

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-25

Study Completion Date

2024-07-31

Brief Summary

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Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

Detailed Description

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Frailty is a state of increased vulnerability to stressors with increased rates of poor outcomes. Surgery is one of these stressors, and previous research has therefore shown increased rates of morbidity and mortality in frail patients undergoing surgery. Prehabilitation programs can help mitigate the negative outcomes associated with frailty. The investigators hope to implement a newly developed prehabilitation pilot program in the Maine Medical Center Surgical Oncology Clinic to initially evaluate adherence, self-efficacy, and health-related quality of life.

The investigators now hope to implement this prehabilitation program in the clinics at Maine Medical Center. Our long term goal is the introduce this program in all surgical specialties; but first, the investigators plan to assess adherence, patient self-efficacy, frailty and health-related quality of life through a pilot study in the surgical oncology clinic.

Conditions

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Prehabilitation Oncology Surgical Oncology

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prehabilitation Intervention Program

Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete

Group Type EXPERIMENTAL

Thinkific Prehabilitation Exercise Program

Intervention Type OTHER

Prehabilitation exercise program through the Thinkific platform

Interventions

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Thinkific Prehabilitation Exercise Program

Prehabilitation exercise program through the Thinkific platform

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Subjects ≥18 years old
2. Evaluated at Maine Medical Center by surgical oncology service
3. Planned surgical intervention for gastrointestinal oncologic condition
4. Score ≥40 on Risk Analysis Index frailty screening
5. Physically able to participate in prehabilitation exercises
6. Home internet access and established email account
7. Able to understand the English language

Exclusion Criteria

1. Patients unable to participate in exercises included in prehabilitation program
2. Patients with impaired decision making capacity
3. Those in a high risk community: prisoners and pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts Medical Center

OTHER

Sponsor Role collaborator

MaineHealth

OTHER

Sponsor Role lead

Responsible Party

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Laura Nicolais

Timothy Fitzgerald: Associate Medical Director. Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maine Medical Center

Portland, Maine, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Laura Nicolais

Role: CONTACT

207-662-2515

Facility Contacts

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Timothy Fitzgerald

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1855206

Identifier Type: -

Identifier Source: org_study_id

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