Implementation of a Prehabilitation Program for Surgical Patients

Not Applicable

Recruiting

• Conditions: Oncology; Surgical Oncology; Prehabilitation
• Interventions: Other: Thinkific Prehabilitation Exercise Program

• Registration Number: NCT05377970
• Lead Sponsor: MaineHealth

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-04-08
• Study First Submitted QC: 2022-05-11
• Study First Posted: 2022-05-17
• Study Start: 2022-06-25
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Read More

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
4. Those who do not meet the above inclusion criteria

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prehabilitation Intervention Program	Thinkific Prehabilitation Exercise Program	Patients enrolled in this arm will receive the preabilitation intervention program prior to their surgery to complete

Primary Outcome Measures

Name	Time	Method
Patient Satisfaction	Last day of prehabilitation program (within week prior to surgery)	Assess patient satisfaction and barriers to adherence through a post prehab program survey.
Frailty (Risk Analysis Index)	Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months	Evaluate change in frailty using Risk Analysis Index before and after participation in the prehabilitation program.
Participant adherence to prehab program	Through study completion, on average 3 months	Evaluate adherence through analysis of patient maintained exercise logs via number of days completed
Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program	Through study completion, on average 3 months	Assess self-efficacy by evaluating the relationship between pre-program Self-Efficacy for Home Exercise Program Scale (0-72) score and adherence.
Quality of Life (Short Form- 36 Survey)	Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery)	Evaluate change in health-related quality of life before and after participation in the prehabilitation program.

Trial Locations

Locations (1)

Maine Medical Center; 🇺🇸 Portland, Maine, United States