Recruiting

Prehabilitation Program

Sponsor:

MaineHealth

Code:

NCT05377970

Conditions

Prehabilitation

Oncology

Surgical Oncology

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thinkific Prehabilitation Exercise Program

Study Details

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.

Conditions

Prehabilitation

Oncology

Surgical Oncology

Study ID

NCT05377970

Start date

Jun 25, 2022

Status verified date

Oct, 2023

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jun 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
4. Those who do not meet the above inclusion criteria

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Prehabilitation Intervention Program

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

Interventions

Thinkific Prehabilitation Exercise Program

Prehabilitation exercise program through the Thinkific platform

Primary outcome measure

  • Participant adherence to prehab program [ Time Frame: Through study completion, on average 3 months ]
  • Correlation between patient pre-program self-efficacy evaluation and measured adherence to study prehabilitation program [ Time Frame: Through study completion, on average 3 months ]
  • Patient Satisfaction [ Time Frame: Last day of prehabilitation program (within week prior to surgery) ]
  • Quality of Life (Short Form- 36 Survey) [ Time Frame: Completed at Day 0, Two weeks, Four weeks and Last day of prehabilitation program (within week prior to surgery) ]
  • Frailty (Risk Analysis Index) [ Time Frame: Evaluated on Day 0 and at last visit prior to surgery, an average of 3 months ]

Central Contacts and Locations

Central contacts

Laura Nicolais

207-662-2515LNicolais@mmc.org

Locations

Maine Medical Center

Recruiting

Portland, Maine, United States, 04101

More Information

Sponsor

MaineHealth

Last update posted

Oct 24, 2023

Last verified

Oct, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by MaineHealth on 2023-10-24.