Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Feasibility of the Prehabilitation Program
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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))
Investigators
Dae Hyun Kim
Associate Professor of Medicine
Beth Israel Deaconess Medical Center