NCT05752474

Multi-Component Prehabilitation for Major Elective Surgery

Completed NA Results posted Last updated 3 December 2025

What this trial tests

NA trial testing Exercise in Frailty in 30 participants. Completed in 16 January 2025.

Timeline

27 March 2023

Primary endpoint
16 January 2025

16 January 2025

Quick facts

Lead sponsor	Beth Israel Deaconess Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	27 March 2023
Primary completion	16 January 2025
Estimated completion	16 January 2025
Sites	1 location across United States

Drugs / interventions tested

• Exercise
• Nutrition
• Meditation
• Cognitive Behavioral Intervention

Conditions studied

• Frailty — all drugs for Frailty →
• Functional Recovery — all drugs for Functional Recovery →
• Prehabilitation — all drugs for Prehabilitation →

Sponsor

Beth Israel Deaconess Medical Center

Who can join

65 and older, any sex, with Frailty or Functional Recovery. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of the Prehabilitation Program Primary · 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).

Group	Value	95% CI
Prehabilitation	19

Change in Gait Speed Secondary · Between pre-intervention baseline and post-intervention (up to 4 weeks)

Measurement: gait speed (meters/second) over 5-meter fast walk, post-intervention minus pre-intervention baseline Range: 0 to 2 meter/second Interpretation: Higher values indicate faster gait.

Group	Value	95% CI
Prehabilitation	0.2	0.0 – 0.4

Change in 5-chair Stand Test Time Secondary · Between pre-intervention baseline and post-intervention (up to 4 weeks)

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.

Group	Value	95% CI
Prehabilitation	-3.4	-6.9 – 0.0

Change in Dominant Handgrip Strength Secondary · Between pre-intervention baseline and post-intervention (up to 4 weeks)

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

Group	Value	95% CI
Prehabilitation	1.6	-2.1 – 5.3

Adherence to Exercise Secondary · Post-intervention (up to 4 weeks)

Measurement: percentage of physical therapy sessions attended Range: 0-100% (higher values indicate better adherence)

Group	Value	95% CI
Prehabilitation	190

Adherence to Nutrition Secondary · Post-intervention (up to 4 weeks)

Measurement: percentage of nutrition sessions attended Range: 0-100% (higher values indicate better adherence)

Group	Value	95% CI
Prehabilitation	80

Adherence to Meditation Secondary · Post-intervention (up to 4 weeks)

Measurement: percentage of meditation sessions attended Range: 0-100% (higher values indicate better adherence)

Group	Value	95% CI
Prehabilitation	71

Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score Secondary · Between pre-intervention baseline and 90 days after surgery

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

Group	Value	95% CI
Prehabilitation	4.4	3.0 – 5.9

Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score Secondary · Between pre-intervention baseline and 90 days after surgery

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

Group	Value	95% CI
Prehabilitation	-6.4	-7.8 – -4.9

Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score Secondary · Between pre-intervention baseline and 90 days after surgery

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

Group	Value	95% CI
Prehabilitation	-2.6	-3.7 – -1.5

Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score Secondary · Between pre-intervention baseline and 90 days after surgery

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

Group	Value	95% CI
Prehabilitation	-4.8	-6.3 – -3.3

Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score Secondary · Between pre-intervention baseline and 90 days after surgery

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

Group	Value	95% CI
Prehabilitation	-3.0	-4.7 – -1.3

Adverse events — posted to ClinicalTrials.gov

Time frame: From enrollment until 90 days post-surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prehabilitation

Serious: 1/28 (4%)

Deaths: 1/28

Serious adverse events (1 terms)

Reaction	System	Prehabilitation
Esophageal bleeding	Gastrointestinal disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Prehabilitation
Gastrointestinal discomforts	Gastrointestinal disorders	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—

Most-reported serious reactions: Esophageal bleeding.

Data from ClinicalTrials.gov NCT05752474 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Multi-Component Prehabilitation Program for Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study.
   Wang KY, Xu K, Liu Y, Alshanniek S, et al · · 2025 · cited 1× · PMID 40916355 · DOI 10.1111/jgs.70095
2. Barriers and facilitators to prehabilitation participation among older adults undergoing major elective surgery: a qualitative study using the capability, opportunity, motivation - behavior model.
   Wang KY, Nguyen CY, Xu K, Liu Y, et al · · 2026 · PMID 41668027 · DOI 10.1186/s12877-026-07101-w