Clinical trial NCT05752474: Multi-Component Prehabilitation for Major Elective Surgery
Official title: Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frailty
Keywords: Prehabilitation
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Hebrew SeniorLife
First posted: 2023-03-02
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Patient has a major cognitive impairment confirmed by telephone Montreal Cognitive Assessment (MoCA) \<18 or Brief Capacity Assessment Questionnaire
* Patients with chronic kidney disease stage 3 or higher will be excluded from receiving protein supplement of the prehabilitation program

Primary outcomes:
measure: Feasibility of the prehabilitation program
timeFrame: 1 month
Secondary outcomes:
measure: Change in 5-chair stand test time
timeFrame: 1 month
measure: Change in dominant handgrip strength (kg)
timeFrame: 1 month
measure: Change in protein intake (grams)
timeFrame: 1 month
measure: Adherence to exercise
timeFrame: 1 month
measure: Adherence to protein intake
timeFrame: 1 month
measure: Adherence to meditation
timeFrame: 1 month
measure: Adverse events
timeFrame: 1 month
measure: Change in Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) score in participation in social roles/activities (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Anxiety (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Depression (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Fatigue (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Pain interference (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Pain intensity (1 question)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Physical function (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Sleep disturbance (4 questions)
timeFrame: 1 month
measure: Change in PROMIS-CAT score in Cognitive function (12 questions)
timeFrame: 1 month
Other outcomes:
measure: 3-D Confusion Assessment Method
timeFrame: 1 month
measure: Postoperative Quality of Recovery Scale
timeFrame: 1 month
measure: Comprehensive complication index
timeFrame: 1 month
measure: Length of stay (time to readiness to discharge)
timeFrame: 1 month
measure: 30-day readmission from all causes
timeFrame: 1 month
measure: 30-day mortality from all causes
timeFrame: 1 month
measure: 90-day mortality from all causes
timeFrame: 3 months
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215
name: Dae Hyun Kim, MD, ScD
role: PRINCIPAL_INVESTIGATOR
References: