Multi-Component Prehabilitation for Major Elective Surgery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Frailty

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Nutrition
* Behavioral: Meditation
* Behavioral: Cognitive Behavioral Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>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<br>* 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.<br>Behavioral: Nutrition<br>* 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).<br>Behavioral: Meditation<br>* 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.<br>Behavioral: Cognitive Behavioral Intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 1 month | 

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 minus pre-prehabilitation Range: -60 to 60 seconds (higher values indicate worsening performance) | 1 month | 
| 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) | 1 month | 
| 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) | 1 month | 
| 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) | 1 month | 
| 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) | 1 month | 
| 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) | 1 month | 
| Adverse events | Measurement: proportion of patients who experience any adverse events per self-report Range: 0-100% (higher values indicate more adverse events) | 1 month | 
| 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 | 1 month | 
| Change in PROMIS-CAT score in Anxiety (4 questions) | Measurement: self-reported measure of anxiety | 1 month | 
| Change in PROMIS-CAT score in Depression (4 questions) | Measurement: self-reported measure of depression | 1 month | 
| Change in PROMIS-CAT score in Fatigue (4 questions) | Measurement: self-reported measure of fatigue | 1 month | 
| Change in PROMIS-CAT score in Pain interference (4 questions) | Measurement: self-reported measure of pain interference | 1 month | 
| Change in PROMIS-CAT score in Pain intensity (1 question) | Measurement: self-reported measure of pain intensity | 1 month | 
| Change in PROMIS-CAT score in Physical function (4 questions) | Measurement: self-reported measure of physical function | 1 month | 
| Change in PROMIS-CAT score in Sleep disturbance (4 questions) | Measurement: self-reported measure of sleep disturbance | 1 month | 
| Change in PROMIS-CAT score in Cognitive function (12 questions) | Measurement: self-reported measure of cognitive abilities | 1 month |