Multi-Component Prehabilitation for Major Elective Surgery

Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study

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.

Study Overview

• Status: Completed
• Conditions: Frailty; Functional Recovery; Prehabilitation
• Intervention / Treatment: Behavioral: Exercise; Behavioral: Nutrition; Behavioral: Meditation; Behavioral: Cognitive Behavioral Intervention

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Prehabilitation; This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.

Behavioral: Exercise; Physical therapy targeting flexibility, strength, and endurance will be delivered at the participant's home, center-based, or virtually via a twice-weekly (on average) schedule to provide a total of about 6-8 sessions during the 3-4 week study period. Participants will be asked to participate in self-directed exercise for at least 30 minutes per day for 4 or more days per week.; Behavioral: Nutrition; One-hour virtual group nutrition education classes will be held once per week by a dietitian, focusing on optimal protein intake (1.2 grams per kg of body weight) for lean body mass preservation (from food sources and oral nutritional supplements) and muscle gain. Participants will also receive oral nutritional supplements (20-30 grams of protein/day provided by our study team).; Behavioral: Meditation; One-hour virtual group meditation sessions will be held once per week by an experienced meditation teacher. Classes will focus on breathing techniques, yoga, and mindful meditation practices. Participants will be asked to participate in self-directed meditation for at least 12 minutes daily.; Behavioral: Cognitive Behavioral Intervention; A 30-min telephone-based session with individual patients will take place to deliver cognitive behavioral strategies once per week by a professionally trained clinician. These strategies include education about frailty and surgery, increasing positive beliefs of the benefits of exercise and nutrition, discussing barriers, setting individualized goals for surgery and recovery, developing a detailed exercise and nutrition plan (including logistics), self-monitoring of progress using weekly exercise, diet, and meditation logs, and enhancing self-efficacy through the celebration of small wins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the Prehabilitation Program	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).	Post-intervention (up to 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 5-chair Stand Test Time	Measurement: Time to complete 5 chair stands (seconds), post-prehabilitation (up to 4 weeks) minus pre-prehabilitation baseline Range: 0 to 60 seconds Interpretation: Higher values indicate worse lower extremity strength.	Between pre-intervention baseline and post-intervention (up to 4 weeks)
Change in Dominant Handgrip Strength	Measurement: Average of 3 measurements of dominant handgrip strength (kilograms) measured using a Jamar dynamometer, post-prehabilitation (up to 4 weeks) minus pre-prehabilitation baseline Range: 0 to 60 kilograms Interpretation: Higher values indicate greater muscle strength	Between pre-intervention baseline and post-intervention (up to 4 weeks)
Adherence to Exercise	Measurement: percentage of physical therapy sessions attended Range: 0-100% (higher values indicate better adherence)	Post-intervention (up to 4 weeks)
Adherence to Nutrition	Measurement: percentage of nutrition sessions attended Range: 0-100% (higher values indicate better adherence)	Post-intervention (up to 4 weeks)
Adherence to Meditation	Measurement: percentage of meditation sessions attended Range: 0-100% (higher values indicate better adherence)	Post-intervention (up to 4 weeks)
Adverse Events	Measurement: percentage of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)	Between pre-intervention baseline and post-intervention (up to 4 weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score	Measurement: Self-reported measure of physical function, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate better physical function	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score	Measurement: Self-reported measure of anxiety, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater anxiety	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score	Measurement: Self-reported measure of depression, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate more depressive mood	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score	Measurement: Self-reported measure of fatigue, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate worse fatigue	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score	Measurement: Self-reported measure of sleep disturbance, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater sleep disturbance	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Social Roles/Activities Participation T Score	Measurement: Self-reported measure of participation in social roles/activities, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater participation in social roles/activities	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Interference T Score	Measurement: Self-reported measure of pain interference, 90 days after surgery minus pre-intervention baseline Range: Standardized score with a mean of 50 and a standard deviation of 10 Interpretation: Higher scores indicate greater pain interference	Between pre-intervention baseline and 90 days after surgery
Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Intensity Score	Measurement: Self-reported measure of pain intensity, 90 days after surgery minus pre-intervention baseline Range: 0 to 10 Interpretation: Higher scores indicate greater pain intensity	Between pre-intervention baseline and 90 days after surgery
3-D Confusion Assessment Method	Measurement: percentage of patients who develop delirium according to 3-D Confusion Assessment Method within 3 days of surgery	Between postoperative day 1 and day 3
Comprehensive Complication Index	Measurement: a composite complication grading system by Clavien-Dindo Classification (CDC) after an intervention Range: 0 (no complications) to 100 (death) Interpretation: Higher scores indicate more severe complications	1 month after surgery
Length of Stay	Measurement: Number of hospital days from surgery until discharge	Between surgery and 1 month after surgery
30-day Readmission From All Causes	Measurement: percentage of patients who were readmitted within 30 days of surgery	Between surgery and 1 month after surgery
30-day Mortality From All Causes	Measurement: proportion of patients who died within 30 days of surgery	1 month
90-day Mortality From All Causes	Measurement: percentage of patients who died within 90 days of surgery	Between surgery and 90 days after surgery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Hebrew SeniorLife
• Investigators: Principal Investigator: Dae Hyun Kim, MD, ScD, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Boston, MA 02215

Publications and helpful links

General Publications

• Wang KY, Xu K, Liu Y, Alshanniek S, Newmeyer N, Mesnik L, Prudhivi V, Chase T, Rangasamy V, Sison SM, Shi SM, Travison TG, Subramaniam B, Kim DH. Multi-Component Prehabilitation Program for Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study. J Am Geriatr Soc. 2025 Sep 7:10.1111/jgs.70095. doi: 10.1111/jgs.70095. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Actual): January 16, 2025
• Study Completion (Actual): January 16, 2025

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: February 22, 2023
• First Posted (Actual): March 2, 2023

Study Record Updates

• Last Update Posted (Estimated): December 3, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Surgery; Feasibility Studies; Prehabilitation
• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Frailty; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Population Characteristics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Health Status; Demography; Relaxation Therapy; Exercise; Nutritional Status; Meditation
• Other Study ID Numbers: 2022P000090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Because this is a feasibility study of a multicomponent prehabilitation intervention, we do not plan to share individual participant data to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No