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Completed

NCT Number: NCT05752474

Multi-Component Prehabilitation for Major Elective Surgery

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.

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Key information

Conditions

Frailty Functional Recovery Pathologic Processes Pathological Conditions, Signs and Symptoms Prehabilitation

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise

Behavioral

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.

Nutrition

Behavioral

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).

Meditation

Behavioral

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.

Cognitive Behavioral Intervention

Behavioral

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.

Primary outcomes

  1. Feasibility of the Prehabilitation Program

    Time frame: 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).

Secondary outcomes

  1. Change in 5-chair Stand Test Time

    Time frame: 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.

  2. Change in Dominant Handgrip Strength

    Time frame: 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

  3. Adherence to Exercise

    Time frame: Post-intervention (up to 4 weeks)

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

  4. Adherence to Nutrition

    Time frame: Post-intervention (up to 4 weeks)

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

  5. Adherence to Meditation

    Time frame: Post-intervention (up to 4 weeks)

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

  6. Adverse Events

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

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

Other outcomes

  1. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Physical Function T Score

    Time frame: 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

  2. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Anxiety T Score

    Time frame: 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

  3. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Depression T Score

    Time frame: 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

  4. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Fatigue T Score

    Time frame: 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

  5. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Sleep Disturbance T Score

    Time frame: 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

  6. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Social Roles/Activities Participation T Score

    Time frame: Between pre-intervention baseline and 90 days after surgery

    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

  7. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Interference T Score

    Time frame: Between pre-intervention baseline and 90 days after surgery

    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

  8. Change in Patient Reported Outcome Measurement Information System (PROMIS)-Computer Adaptive Test (CAT) Pain Intensity Score

    Time frame: Between pre-intervention baseline and 90 days after surgery

    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

  9. 3-D Confusion Assessment Method

    Time frame: Between postoperative day 1 and day 3

    Measurement: percentage of patients who develop delirium according to 3-D Confusion Assessment Method within 3 days of surgery

  10. Comprehensive Complication Index

    Time frame: 1 month after surgery

    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

  11. Length of Stay

    Time frame: Between surgery and 1 month after surgery

    Measurement: Number of hospital days from surgery until discharge

  12. 30-day Readmission From All Causes

    Time frame: Between surgery and 1 month after surgery

    Measurement: percentage of patients who were readmitted within 30 days of surgery

  13. 30-day Mortality From All Causes

    Time frame: 1 month

    Measurement: proportion of patients who died within 30 days of surgery

  14. 90-day Mortality From All Causes

    Time frame: Between surgery and 90 days after surgery

    Measurement: percentage of patients who died within 90 days of surgery

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Hebrew SeniorLife

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 2, 2023
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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