Multi-Component Prehabilitation for Major Elective Surgery

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-27

Study Completion Date

2025-01-16

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.

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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, 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.

Conditions

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Frailty Functional Recovery Prehabilitation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prehabilitation

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

Group Type EXPERIMENTAL

Exercise

Intervention Type 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

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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Exercise

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

Nutrition

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

Meditation

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

Cognitive Behavioral Intervention

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No