The Impact of Prehabilitation

Study Overview
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Brief Summary
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While numerous studies have assessed the promising impacts of prehabilitation, there is a lack of prehabilitation research within lower socioeconomic patient populations. Often for prehabilitation studies, patients are heavily involved in full scale exercise and nutrition programs weeks before the scheduled procedure. In underserved populations, programs such as these are often not feasible due to lack of transport, resources, and other barriers to healthcare. The investigators seek to evaluate the effectiveness of inexpensive interventions in lower socioeconomic populations. The investigators hypothesize that barriers to prehabilitation are environmental and that prehabilitation interventions tailored for lower socioeconomic (SES) populations will improve time to discharge, mobility, and in turn, readmission rates. The study population for this clinical trial will be initially outpatient (patients will be seen at preoperative surgical clinic, 6-8 weeks prior to surgery) and then later inpatient (during postoperative recovery period). Patients will be within the general surgery, colorectal, and surgical oncology departments at Boston Medical Center (BMC). The anticipated sample size is 60 participants (30 in the intervention/prehabilitation arm and 30 in the control/usual care arm). Participants in the intervention arm will participate in a mobility and step tracking intervention aimed at improving postoperative outcomes. The control group will follow routine standard of care at BMC for preoperative and postoperative care.

Official Title
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The Impact of Prehabilitation Measures on Postoperative Outcomes

Conditions
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Post Operative Complications

Intervention / Treatment
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* Other: Preoperative education
* Behavioral: Moderate aerobic exercise
* Other: Text messages
* Behavioral: Pedometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients within general surgery, colorectal, and surgical oncology departments at Boston Medical Center. English or Spanish speaking Able to ambulate without cane, walker, wheelchair Surgery scheduled within 4-8 weeks Must have cell phone with internet access and text message capabilities JH-HLM score of 6 Exclusion Criteria: Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation group<br>Watch a video created by the investigators, discussing exercise prior to surgery, receive text message reminders to begin exercise before surgery, and take walking tests before and after surgery. | Other: Preoperative education<br>* The intervention will be an instructional video describing proper walking technique particularly up flights of stairs for patients to do at home. This will be shown at preoperative surgical clinic and will be available for access at home from patient's cell phones. The video is currently in production at BMC. Additionally, text reminders will be sent daily to remind patients to walk at home.<br>Behavioral: Moderate aerobic exercise<br>* Participants will be encouraged to compete 140-150 minutes of moderate aerobic exercise per week- achieved by two walking sessions per day 10-11 minutes in length (realistic/achievable goal)<br>Other: Text messages<br>* Text reminders will be sent daily to remind patients to walk at home.<br>Behavioral: Pedometer<br>* Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer<br>|
| No Intervention: Control group<br>Receive the usual preoperative and post operative care and they will be provided a pedometer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline 6 minute walking test (6MWT) | The 6MWT is an exercise test that measure patient endurance and aerobic capacity. Participants will walk while attached to pulse oximetry for 6 minutes and total distance walked will be recorded. The higher a person's score, the better their exercise tolerance. | Baseline (preoperatively) | 
| Postoperative 6 minute walking test (6MWT) | The 6MWT is an exercise test that measure patient endurance and aerobic capacity. Participants will walk while attached to pulse oximetry for 6 minutes and total distance walked will be recorded. The higher a person's score, the better their exercise tolerance. | Postoperative, 24-48 hours after surgery | 
| Baseline Activity Measure for Post Acute Care (AMPAC) | This tool aims to assess a patient's physical function status as it relates to activities of daily living as a brief questionnaire. Questions assess ability to perform activities such as dressing and ambulating.Known as 6-Clicks due to being composed of six scored patient activity questions, a patient's 6-Clicks score falls on a 6- to 24-point scale where a score of 6 represents total functional impairment and a score of 24 represents total absence of impairment. | Baseline (preoperatively) | 
| Postoperative Activity Measure for Post Acute Care (AMPAC) | This tool aims to assess a patient's physical function status as it relates to activities of daily living as a brief questionnaire. Questions assess ability to perform activities such as dressing and ambulating.Known as 6-Clicks due to being composed of six scored patient activity questions, a patient's 6-Clicks score falls on a 6- to 24-point scale where a score of 6 represents total functional impairment and a score of 24 represents total absence of impairment. | Postoperative, 24-48 hours after surgery | 
| Baseline Frailty Scoring | Clinical frailty score is a 9 point scale used to assess frailty in patients. A score of 1 indicates Very Fit, 2 indicates Fit, and so on. A frailty score of 9 indicates terminally ill. The higher the frailty score, the more frail a patient is considered. Clinicians use their best judgement given a variety of patient factors including physical fitness, motivation, and medical comorbidities | Baseline (preoperatively) | 
| Postoperative Frailty Scoring | Clinical frailty score is a 9 point scale used to assess frailty in patients. A score of 1 indicates Very Fit, 2 indicates Fit, and so on. A frailty score of 9 indicates terminally ill. The higher the frailty score, the more frail a patient is considered. Clinicians use their best judgement given a variety of patient factors including physical fitness, motivation, and medical comorbidities. | Postoperative, 24-48 hours after surgery | 
| Baseline John's Hopkins Highest Level of Mobility (JH-HLM) Scale | The JH-HLM is an ordinal scale for documenting a patient's highest observed level of activity in the bed, chair, standing, and walking. It has a range from 1 to 8 where lying in bed (score = 1) to ambulating >250 feet (score = 8). HIgher scores indicate greater mobility. | Baseline (preoperatively) | 
| Postoperative John's Hopkins Highest Level of Mobility (JH-HLM) Scale | The JH-HLM is an ordinal scale for documenting a patient's highest observed level of activity in the bed, chair, standing, and walking. It has a range from 1 to 8 where lying in bed (score = 1) to ambulating >250 feet (score = 8). HIgher scores indicate greater mobility. | Postoperative, 24-48 hours after surgery | 
| Baseline Veterans Rand 12 (VR-12) Item Health Survey | The VR-12 is a patient reported outcome measure that aims to assess patients health related qualify of life as it relates to their physical and mental health.The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. | Baseline (preoperatively) | 
| Postoperative Veterans Rand 12 (VR-12) Item Health Survey | The VR-12 is a patient reported outcome measure that aims to assess patients health related qualify of life as it relates to their physical and mental health.The results of the VR-12 are summarized as two scores - a Mental Component Score (MCS) and a Physical Component Score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). The United States population average PCS and MCS are both 50 points. | Postoperative, 24-48 hours after surgery | 
| Adherence to mobility intervention assessed by text survey data | Participants will be asked daily regarding home activity level (minutes of walking per day) as a measure of adherence to prehabilitation walking program. | 8 weeks | 
| Adherence to mobility intervention assessed by pedometer step count | Participants will be asked daily about their pedometer step count as a measure of adherence to prehabilitation walking program. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission rate | Through chart review, the participants readmission rate back into the hospital (postoperatively) will be compared between the intervention and control group. | 8 weeks | 
| Length of hospital stay | The number of days participants are hospitalized will be abstracted from the participants medical records. | 6-8 weeks | 
| Complications from surgery | Through chart review, the rate of complications will be compared intervention and control group. Complications comprise of: infection of surgical site, hemorrhage, deep vein thrombosis and pulmonary embolism, pulmonary complications (ie. atelectasis, pneumonia), and death. | 2 months post surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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6 minute Walking test, Patient texting, Prehabilitation, Patient video education, Instructional walking video