Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Beth Israel Deaconess Medical Center
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Feasibility of the Prehabilitation Program
- Status
- Completed
- Last Updated
- 5 months ago
Overview
Brief Summary
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.
Detailed Description
We will assess the feasibility of delivering a multicomponent prehabilitation, which consists of exercise (supervised by physical therapist), nutritional intervention (nutritional supplement and group education), meditation (group class), and cognitive behavioral intervention over 3-4 weeks before major elective abdominal, gynecological oncologic, urologic surgery, and cardiovascular procedures. We will also measure patient-centered outcomes (Patient-Reported Outcomes Measurement Information System) at 30 and 90 days after surgery. The target enrollment is 30 patients.
Investigators
Dae Hyun Kim
Associate Professor of Medicine
Beth Israel Deaconess Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patient is scheduled to have a gastrointestinal, gynecological oncologic, urologic, and cardiovascular procedure
- •Age 70 years+
- •Age 65 years+ AND high risk per surgeon's clinical judgment
- •Patient provides an informed e-consent or remote consent
Exclusion Criteria
- •Surgery is scheduled less than 21 days
- •Patient is considered an inappropriate candidate per the surgeon's assessment
- •Non-English speaking
- •Major cognitive impairment
- •Patients with chronic kidney disease stage 3 or higher will be excluded from receiving protein supplement of the prehabilitation program
Outcomes
Primary Outcomes
Feasibility of the Prehabilitation Program
Time Frame: Post-intervention (up to 4 weeks)
Measurement: Percentage of patients to whom we can deliver an adequate dose (≥50% of the planned sessions) of the 3 core interventions: physical therapy (≥4/8 sessions), nutrition (≥2/3-4 sessions), and meditation (≥2/3-4 sessions). Range: 0-100% (higher values indicate higher feasibility).
Secondary Outcomes
- Change in 5-chair Stand Test Time(Between pre-intervention baseline and post-intervention (up to 4 weeks))
- Change in Dominant Handgrip Strength(Between pre-intervention baseline and post-intervention (up to 4 weeks))
- Adherence to Exercise(Post-intervention (up to 4 weeks))
- Adherence to Nutrition(Post-intervention (up to 4 weeks))
- Adherence to Meditation(Post-intervention (up to 4 weeks))
- Adverse Events(Between pre-intervention baseline and post-intervention (up to 4 weeks))