Clinical trial NCT06181253: The Impact of Prehabilitation
Official title: The Impact of Prehabilitation Measures on Postoperative Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Operative Complications
Keywords: Prehabilitation
Patient video education
Instructional walking video
6 minute Walking test
Patient texting
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2023-12-26
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Baseline 6 minute walking test (6MWT)
timeFrame: Baseline (preoperatively)
measure: Postoperative 6 minute walking test (6MWT)
timeFrame: Postoperative, 24-48 hours after surgery
measure: Baseline Activity Measure for Post Acute Care (AMPAC)
timeFrame: Baseline (preoperatively)
measure: Postoperative Activity Measure for Post Acute Care (AMPAC)
timeFrame: Postoperative, 24-48 hours after surgery
measure: Baseline Frailty Scoring
timeFrame: Baseline (preoperatively)
measure: Postoperative Frailty Scoring
timeFrame: Postoperative, 24-48 hours after surgery
measure: Baseline John's Hopkins Highest Level of Mobility (JH-HLM) Scale
timeFrame: Baseline (preoperatively)
measure: Postoperative John's Hopkins Highest Level of Mobility (JH-HLM) Scale
timeFrame: Postoperative, 24-48 hours after surgery
measure: Baseline Veterans Rand 12 (VR-12) Item Health Survey
timeFrame: Baseline (preoperatively)
measure: Postoperative Veterans Rand 12 (VR-12) Item Health Survey
timeFrame: Postoperative, 24-48 hours after surgery
measure: Adherence to mobility intervention assessed by text survey data
timeFrame: 8 weeks
measure: Adherence to mobility intervention assessed by pedometer step count
timeFrame: 8 weeks
Secondary outcomes:
measure: Readmission rate
timeFrame: 8 weeks
measure: Length of hospital stay
timeFrame: 6-8 weeks
measure: Complications from surgery
timeFrame: 2 months post surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Anesthesiology Department
name: Nicole Spence, MD
role: PRINCIPAL_INVESTIGATOR
References: