Clinical Trials Directory

Trials / Terminated

TerminatedNCT06181253

The Impact of Prehabilitation

The Impact of Prehabilitation Measures on Postoperative Outcomes

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
3 (actual)
Sponsor
Boston Medical Center · Academic / Other
Sex
All
Age
21 Years – 65 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERPreoperative educationThe 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.
BEHAVIORALModerate aerobic exerciseParticipants 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)
OTHERText messagesText reminders will be sent daily to remind patients to walk at home.
BEHAVIORALPedometerParticipants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer

Timeline

Start date
2024-05-02
Primary completion
2025-12-23
Completion
2025-12-23
First posted
2023-12-26
Last updated
2026-04-01

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06181253. Inclusion in this directory is not an endorsement.