Trial Outcomes & Findings for Multi-Component Prehabilitation for Major Elective Surgery (NCT NCT05752474)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

Post-intervention (up to 4 weeks)

Results posted on

2025-12-03

Participant Flow

30 patients were enrolled in the single-arm trial.

Participant milestones

Participant milestones
Measure	Prehabilitation: An Individualized, Multi-component Program This single-arm trial was conducted at Beth Israel Deaconess Medical Center (enrollment site) and Hebrew Rehabilitation Center (intervention site) in Boston, Massachusetts, from March 2023 to January 2025. Patients 65 years or older scheduled for major abdominal, gynecological oncologic, urologic, and cardiovascular procedures were eligible. The program included the following components: 1. Physical therapy: Participants received two one-hour individual sessions per week, delivered by a physical therapist at the Hebrew Rehabilitation Center. 2. Nutrition: Participants received a one-hour individual nutritional counseling virtually by a registered dietitian. They were supplied with a protein bar or drink containing 20 grams of protein and instructed to consume daily, preferably within 30 minutes of exercise, to maximize muscle protein synthesis. 3. Meditation: A meditation instructor at the Beth Israel Deaconess Medical Center Sadhguru Center for a Conscious Planet led a weekly one-hour virtual group meditation session. These sessions focused on breathing techniques and mindfulness practices to alleviate psychological stress, manage anxiety, and promote mental well-being.
Overall Study STARTED	30
Overall Study Initiated Intervention	28
Overall Study Underwent Surgery	23
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Multi-Component Prehabilitation for Major Elective Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prehabilitation: An Individualized, Multi-component Program n=30 Participants This single-arm trial was conducted at Beth Israel Deaconess Medical Center (enrollment site) and Hebrew Rehabilitation Center (intervention site) in Boston, Massachusetts, from March 2023 to January 2025. Patients 65 years or older scheduled for major abdominal, gynecological oncologic, urologic, and cardiovascular procedures were eligible. The program included the following components: 1. Physical therapy: Participants received two one-hour individual sessions per week, delivered by a physical therapist at the Hebrew Rehabilitation Center. 2. Nutrition: Participants received a one-hour individual nutritional counseling virtually by a registered dietitian. They were supplied with a protein bar or drink containing 20 grams of protein and instructed to consume daily, preferably within 30 minutes of exercise, to maximize muscle protein synthesis. 3. Meditation: A meditation instructor at the Beth Israel Deaconess Medical Center Sadhguru Center for a Conscious Planet led a weekly one-hour virtual group meditation session. These sessions focused on breathing techniques and mindfulness practices to alleviate psychological stress, manage anxiety, and promote mental well-being.
Age, Continuous	75.3 years STANDARD_DEVIATION 6.6 • n=3 Participants
Sex: Female, Male Female	12 Participants n=3 Participants
Sex: Female, Male Male	18 Participants n=3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=3 Participants
Race (NIH/OMB) Asian	0 Participants n=3 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=3 Participants
Race (NIH/OMB) Black or African American	3 Participants n=3 Participants
Race (NIH/OMB) White	27 Participants n=3 Participants
Race (NIH/OMB) More than one race	0 Participants n=3 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=3 Participants

PRIMARY outcome

Timeframe: Post-intervention (up to 4 weeks)

Population: This was calculated in 28 patients who initiated the intervention.

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).

Outcome measures

Outcome measures
Measure	Prehabilitation n=28 Participants This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Feasibility of the Prehabilitation Program	19 Participants

SECONDARY outcome

Timeframe: Between pre-intervention baseline and post-intervention (up to 4 weeks)

Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.

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.

Outcome measures

Outcome measures
Measure	Prehabilitation n=25 Participants This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Change in 5-chair Stand Test Time	-3.4 Seconds Interval -6.9 to 0.0

SECONDARY outcome

Timeframe: Between pre-intervention baseline and post-intervention (up to 4 weeks)

Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.

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

Outcome measures

Outcome measures
Measure	Prehabilitation n=25 Participants This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Change in Dominant Handgrip Strength	1.6 Kilograms Interval -2.1 to 5.3

SECONDARY outcome

Timeframe: Post-intervention (up to 4 weeks)

Population: This was calculated in 28 patients who initiated the intervention.

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

Outcome measures

Outcome measures
Measure	Prehabilitation n=208 Number of Sessions This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Adherence to Exercise	190 Number of Sessions

SECONDARY outcome

Timeframe: Post-intervention (up to 4 weeks)

Population: This was calculated in 28 patients who initiated the intervention.

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

Outcome measures

Outcome measures
Measure	Prehabilitation n=104 Number of Sessions This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Adherence to Nutrition	80 Number of Sessions

SECONDARY outcome

Timeframe: Post-intervention (up to 4 weeks)

Population: This was calculated in 28 patients who initiated the intervention.

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

Outcome measures

Outcome measures
Measure	Prehabilitation n=104 Number of Sessions This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Adherence to Meditation	71 Number of Sessions

SECONDARY outcome

Timeframe: Between pre-intervention baseline and post-intervention (up to 4 weeks)

Population: This was calculated in 28 patients who initiated the intervention.

Measurement: percentage of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)

Outcome measures

Outcome measures
Measure	Prehabilitation n=28 Participants This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
Adverse Events	8 Participants

POST_HOC outcome

Timeframe: Between pre-intervention baseline and post-intervention (up to 4 weeks)

Population: This was calculated in 25 patients who initiated the intervention and had the post-intervention measurement.

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.