Multi-Component Prehabilitation for Major Elective Surgery

Not Applicable

Completed

• Conditions: Frailty

• Registration Number: NCT05752474
• Lead Sponsor: Beth Israel Deaconess Medical Center

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 Timeline

• Study First Submitted: 2023-02-22
• Study First Submitted QC: 2023-02-22
• Study First Posted: 2023-03-02
• Study Start: 2023-03-27
• Primary Completion: 2025-01-16
• Study Completion: 2025-01-16
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of the prehabilitation program	1 month	Measurement: Proportion 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 Outcome Measures

Name	Time	Method
Change in 5-chair stand test time	1 month	Measurement: Time to complete 5 chair stands (seconds), post-prehabilitation minus pre-prehabilitation Range: -60 to 60 seconds (higher values indicate worsening performance)
Change in dominant handgrip strength (kg)	1 month	Measurement: average of 3 measurements of dominant handgrip strength, post-prehabilitation minus pre-prehabilitation Range: -50 to 50 kg (higher values indicate improved performance)
Change in PROMIS-CAT score in Pain interference (4 questions)	1 month	Measurement: self-reported measure of pain interference
Change in PROMIS-CAT score in Sleep disturbance (4 questions)	1 month	Measurement: self-reported measure of sleep disturbance
Change in protein intake (grams)	1 month	Measurement: 3-day average protein intake from dietary recall, post-prehabilitation minus pre-prehabilitation Range: -100 to 100 grams higher values indicate greater intake)
Adherence to meditation	1 month	Measurement: proportion of days with ≥12 minutes of meditation during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
Change in PROMIS-CAT score in Fatigue (4 questions)	1 month	Measurement: self-reported measure of fatigue
Adherence to exercise	1 month	Measurement: proportion of days with ≥30 minutes of exercise during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) score in participation in social roles/activities (4 questions)	1 month	Measurement: self-reported measure of participation in social roles/activities
Adherence to protein intake	1 month	Measurement: proportion of oral nutritional supplement consumed over the total number of supplements during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
Adverse events	1 month	Measurement: proportion of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)
Change in PROMIS-CAT score in Anxiety (4 questions)	1 month	Measurement: self-reported measure of anxiety
Change in PROMIS-CAT score in Depression (4 questions)	1 month	Measurement: self-reported measure of depression
Change in PROMIS-CAT score in Pain intensity (1 question)	1 month	Measurement: self-reported measure of pain intensity
Change in PROMIS-CAT score in Physical function (4 questions)	1 month	Measurement: self-reported measure of physical function
Change in PROMIS-CAT score in Cognitive function (12 questions)	1 month	Measurement: self-reported measure of cognitive abilities

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States