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Multi-Component Prehabilitation for Major Elective Surgery

Primary Purpose

Frailty

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise
Nutrition
Meditation
Cognitive Behavioral Intervention
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frailty

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patient is scheduled to have a gastrointestinal, gynecological oncologic, and urologic surgery Patient's frailty index is ≥0.25 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 Patients with chronic kidney disease stage 3 or higher will be excluded from nutrition intervention of the Prehabilitation intervention bundle.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Prehabilitation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Feasibility of the prehabilitation program
    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

    Change in 5-chair stand test time
    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)
    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 protein intake (grams)
    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 exercise
    Measurement: proportion of days with ≥30 minutes of exercise during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
    Adherence to protein intake
    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)
    Adherence to meditation
    Measurement: proportion of days with ≥12 minutes of meditation during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
    Adverse events
    Measurement: proportion of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)
    Change in Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) score in participation in social roles/activities (4 questions)
    Measurement: self-reported measure of participation in social roles/activities
    Change in PROMIS-CAT score in Anxiety (4 questions)
    Measurement: self-reported measure of anxiety
    Change in PROMIS-CAT score in Depression (4 questions)
    Measurement: self-reported measure of depression
    Change in PROMIS-CAT score in Fatigue (4 questions)
    Measurement: self-reported measure of fatigue
    Change in PROMIS-CAT score in Pain interference (4 questions)
    Measurement: self-reported measure of pain interference
    Change in PROMIS-CAT score in Pain intensity (1 question)
    Measurement: self-reported measure of pain intensity
    Change in PROMIS-CAT score in Physical function (4 questions)
    Measurement: self-reported measure of physical function
    Change in PROMIS-CAT score in Sleep disturbance (4 questions)
    Measurement: self-reported measure of sleep disturbance
    Change in PROMIS-CAT score in Cognitive function (12 questions)
    Measurement: self-reported measure of cognitive abilities

    Full Information

    First Posted
    February 22, 2023
    Last Updated
    March 24, 2023
    Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Hebrew SeniorLife
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05752474
    Brief Title
    Multi-Component Prehabilitation for Major Elective Surgery
    Official Title
    Multi-Component Prehabilitation Program for High-Risk Older Adults Undergoing Major Elective Surgery: A Pilot and Feasibility Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 27, 2023 (Anticipated)
    Primary Completion Date
    February 29, 2024 (Anticipated)
    Study Completion Date
    February 29, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Hebrew SeniorLife

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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, and urologic surgery. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Frailty

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prehabilitation
    Arm Type
    Experimental
    Arm Description
    This group will receive a multicomponent prehabilitation intervention (exercise, nutritional intervention, meditation, and cognitive behavioral intervention) for 3-4 weeks prior to surgery.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Nutrition
    Intervention Description
    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).
    Intervention Type
    Behavioral
    Intervention Name(s)
    Meditation
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive Behavioral Intervention
    Intervention Description
    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 Outcome Measure Information:
    Title
    Feasibility of the prehabilitation program
    Description
    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).
    Time Frame
    1 month
    Secondary Outcome Measure Information:
    Title
    Change in 5-chair stand test time
    Description
    Measurement: Time to complete 5 chair stands (seconds), post-prehabilitation minus pre-prehabilitation Range: -60 to 60 seconds (higher values indicate worsening performance)
    Time Frame
    1 month
    Title
    Change in dominant handgrip strength (kg)
    Description
    Measurement: average of 3 measurements of dominant handgrip strength, post-prehabilitation minus pre-prehabilitation Range: -50 to 50 kg (higher values indicate improved performance)
    Time Frame
    1 month
    Title
    Change in protein intake (grams)
    Description
    Measurement: 3-day average protein intake from dietary recall, post-prehabilitation minus pre-prehabilitation Range: -100 to 100 grams higher values indicate greater intake)
    Time Frame
    1 month
    Title
    Adherence to exercise
    Description
    Measurement: proportion of days with ≥30 minutes of exercise during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
    Time Frame
    1 month
    Title
    Adherence to protein intake
    Description
    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)
    Time Frame
    1 month
    Title
    Adherence to meditation
    Description
    Measurement: proportion of days with ≥12 minutes of meditation during the intervention period per self-report Range: 0-100% (higher values indicate better adherence)
    Time Frame
    1 month
    Title
    Adverse events
    Description
    Measurement: proportion of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events)
    Time Frame
    1 month
    Title
    Change in Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive test (CAT) score in participation in social roles/activities (4 questions)
    Description
    Measurement: self-reported measure of participation in social roles/activities
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Anxiety (4 questions)
    Description
    Measurement: self-reported measure of anxiety
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Depression (4 questions)
    Description
    Measurement: self-reported measure of depression
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Fatigue (4 questions)
    Description
    Measurement: self-reported measure of fatigue
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Pain interference (4 questions)
    Description
    Measurement: self-reported measure of pain interference
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Pain intensity (1 question)
    Description
    Measurement: self-reported measure of pain intensity
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Physical function (4 questions)
    Description
    Measurement: self-reported measure of physical function
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Sleep disturbance (4 questions)
    Description
    Measurement: self-reported measure of sleep disturbance
    Time Frame
    1 month
    Title
    Change in PROMIS-CAT score in Cognitive function (12 questions)
    Description
    Measurement: self-reported measure of cognitive abilities
    Time Frame
    1 month
    Other Pre-specified Outcome Measures:
    Title
    3-D Confusion Assessment Method
    Description
    Measurement: proportion of patients who develop delirium according to 3-D Confusion Assessment Method, a clinically validated algorithm of delirium diagnosis, on any of the postoperative days 1 to 3
    Time Frame
    1 month
    Title
    Postoperative Quality of Recovery Scale
    Description
    Measurement: a clinically validated scale that includes physiologic, nociceptive, functional, cognitive, emotional recovery domains assessed as well as overall patient perspective on postoperative day 3
    Time Frame
    1 month
    Title
    Comprehensive complication index
    Description
    Measurement: a composite complication grading system by Clavien-Dindo Classification (CDC) after an intervention
    Time Frame
    1 month
    Title
    Length of stay (time to readiness to discharge)
    Description
    Measurement: number of hospital days from surgery until a patient becomes medically stable for discharge based on clinical notes
    Time Frame
    1 month
    Title
    30-day readmission from all causes
    Description
    Measurement: proportion of patients who were readmitted within 30 days of surgery
    Time Frame
    1 month
    Title
    30-day mortality from all causes
    Description
    Measurement: proportion of patients who died within 30 days of surgery
    Time Frame
    1 month
    Title
    90-day mortality from all causes
    Description
    Measurement: proportion of patients who died within 90 days of surgery
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patient is scheduled to have a gastrointestinal, gynecological oncologic, and urologic surgery Patient's frailty index is ≥0.25 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 Patients with chronic kidney disease stage 3 or higher will be excluded from nutrition intervention of the Prehabilitation intervention bundle.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Natalie M Newmeyer, MS, RD, LDN
    Phone
    774-901-5547
    Email
    nnewmeye@bidmc.harvard.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dae Hyun Kim, MD, ScD
    Phone
    617-278-8180
    Email
    dkim2@bidmc.harvard.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dae Hyun Kim, MD, ScD
    Organizational Affiliation
    Beth Israel Deaconess Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing 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.

    Learn more about this trial

    Multi-Component Prehabilitation for Major Elective Surgery

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