The Impact of Prehabilitation

NCT06181253 | Terminated

• 1 other identifier: H-42768
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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 participants for this clinical trial will be seen four times: initially at the preoperative surgical clinic (6-8 weeks prior to surgery), 1-2 days preop at a pre-procedure clinic, postoperative in the inpatient setting (as soon as the participant is able to ambulate during their hospital stay), and in the postoperative surgical clinic at the postoperative visit. 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.

Conditions

Post Operative Complications

Keywords

Prehabilitation; Patient video education; Instructional walking video; 6 minute Walking test; Patient texting

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Readmission rate

  8 weeks

• Length of hospital stay

  6-8 weeks

• Complications from surgery

  2 months post surgery

Study Arms (2)

Prehabilitation group

EXPERIMENTAL

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; Behavioral: Moderate aerobic exercise; Other: Text messages; Behavioral: Pedometer

Control group

NO INTERVENTION

Receive the usual preoperative and post operative care and they will be provided a pedometer.

Interventions

Preoperative education OTHER

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.

Prehabilitation group

Moderate aerobic exercise BEHAVIORAL

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)

Prehabilitation group

Text messages OTHER

Text reminders will be sent daily to remind patients to walk at home.

Prehabilitation group

Pedometer BEHAVIORAL

Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer

Prehabilitation group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials

Sponsors & Collaborators

• Boston Medical Center: lead

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Study Officials

• Nicole Spence, MD

  Boston Medical Center, Anesthesiology Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 26, 2023
• Study Start: May 2, 2024
• Primary Completion: December 23, 2025
• Study Completion: December 23, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)