Multi-Component Prehabilitation for Major Elective Surgery

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05752474
• Other study ID #: 2022P000090
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: February 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Natalie M Newmeyer, MS, RD, LDN
• Phone: 774-901-5547
• Email: nnewmeye[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Patient is scheduled to have a gastrointestinal, gynecological oncologic, urologic, and cardiovascular procedure

• 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 or Brief Capacity Assessment Questionnaire

• Patients with chronic kidney disease stage 3 or higher will be excluded from nutrition intervention of the Prehabilitation intervention bundle.

Related Conditions & MeSH terms

• Frailty

Intervention

Behavioral:
• 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.
• 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).
• 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.
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Hebrew SeniorLife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	3-D Confusion Assessment Method	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	1 month
Other	Postoperative Quality of Recovery Scale	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	1 month
Other	Comprehensive complication index	Measurement: a composite complication grading system by Clavien-Dindo Classification (CDC) after an intervention	1 month
Other	Length of stay (time to readiness to discharge)	Measurement: number of hospital days from surgery until a patient becomes medically stable for discharge based on clinical notes	1 month
Other	30-day readmission from all causes	Measurement: proportion of patients who were readmitted within 30 days of surgery	1 month
Other	30-day mortality from all causes	Measurement: proportion of patients who died within 30 days of surgery	1 month
Other	90-day mortality from all causes	Measurement: proportion of patients who died within 90 days of surgery	3 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in PROMIS-CAT score in Anxiety (4 questions)	Measurement: self-reported measure of anxiety	1 month
Secondary	Change in PROMIS-CAT score in Depression (4 questions)	Measurement: self-reported measure of depression	1 month
Secondary	Change in PROMIS-CAT score in Fatigue (4 questions)	Measurement: self-reported measure of fatigue	1 month
Secondary	Change in PROMIS-CAT score in Pain interference (4 questions)	Measurement: self-reported measure of pain interference	1 month
Secondary	Change in PROMIS-CAT score in Pain intensity (1 question)	Measurement: self-reported measure of pain intensity	1 month
Secondary	Change in PROMIS-CAT score in Physical function (4 questions)	Measurement: self-reported measure of physical function	1 month
Secondary	Change in PROMIS-CAT score in Sleep disturbance (4 questions)	Measurement: self-reported measure of sleep disturbance	1 month
Secondary	Change in PROMIS-CAT score in Cognitive function (12 questions)	Measurement: self-reported measure of cognitive abilities	1 month