The Impact of Prehabilitation Measures on Postoperative Outcomes
Trial testing simple pre-surgery exercises to improve recovery after surgery
Plain English Summary
The Impact of Prehabilitation is a Not Applicable clinical trial sponsored by Boston Medical Center studying Post Operative Complications. This trial tests if simple exercises and reminders can help patients recover faster after surgery. It is for patients undergoing general surgery, colorectal, or surgical oncology procedures at Boston Medical Center. Participation involves attending clinic visits before and after surgery, and following a daily walking and text reminder program. The alternative is standard post-surgery care without specific pre-surgery exercises. The trial aims to enroll 3 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients scheduled for surgery in the general surgery, colorectal, or surgical oncology departments at Boston Medical Center can join. You must be able to walk without assistance and have a smartphone with internet access. Patients who have difficulty reading or understanding English or Spanish cannot participate. Your surgery must be scheduled within 4 to 8 weeks. This trial is studying Post Operative Complications, so participants generally need a confirmed diagnosis.
What They're Measuring
The trial measures how well patients can walk and how active they are before and after surgery to see if the pre-surgery program helps them regain strength and mobility faster. The specific primary outcome measures are: Baseline 6 minute walking test (6MWT) (Baseline (preoperatively)); Postoperative 6 minute walking test (6MWT) (Postoperative, 24-48 hours after surgery); Baseline Activity Measure for Post Acute Care (AMPAC) (Baseline (preoperatively)); Postoperative Activity Measure for Post Acute Care (AMPAC) (Postoperative, 24-48 hours after surgery); Baseline Frailty Scoring (Baseline (preoperatively)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it explores low-cost ways to help patients, especially those with fewer resources, recover better after surgery, addressing a gap in current prehabilitation programs. This research targets Post Operative Complications, where improved treatment options are needed.
Investor Insight
This trial investigates a low-cost intervention for a common surgical issue, potentially improving patient outcomes and reducing healthcare costs, though its termination suggests challenges in executi
Is This Trial Right for Me?
Ask your doctor if pre-surgery exercises are right for you and how they might help your specific surgery. You will receive instructions and daily text reminders to walk and track your steps. You will attend clinic visits before and after your surgery. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 3 participants
Interventions
- OTHER: Preoperative education — 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.
- BEHAVIORAL: Moderate aerobic exercise — 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)
- OTHER: Text messages — Text reminders will be sent daily to remind patients to walk at home.
- BEHAVIORAL: Pedometer — Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer
Primary Outcomes
- Baseline 6 minute walking test (6MWT) (Baseline (preoperatively))
- Postoperative 6 minute walking test (6MWT) (Postoperative, 24-48 hours after surgery)
- Baseline Activity Measure for Post Acute Care (AMPAC) (Baseline (preoperatively))
- Postoperative Activity Measure for Post Acute Care (AMPAC) (Postoperative, 24-48 hours after surgery)
- Baseline Frailty Scoring (Baseline (preoperatively))
Secondary Outcomes
- Readmission rate (8 weeks)
- Length of hospital stay (6-8 weeks)
- Complications from surgery (2 months post surgery)
Trial Locations
- Boston Medical Center, Boston, Massachusetts, United States
Frequently Asked Questions
What is clinical trial NCT06181253?
NCT06181253 is a Not Applicable INTERVENTIONAL study titled "The Impact of Prehabilitation." It is currently terminated and is sponsored by Boston Medical Center. The trial targets enrollment of 3 participants.
What conditions does NCT06181253 study?
This trial investigates treatments for Post Operative Complications. The primary condition under study is Post Operative Complications.
What treatments are being tested in NCT06181253?
The interventions being studied include: Preoperative education (OTHER), Moderate aerobic exercise (BEHAVIORAL), Text messages (OTHER), Pedometer (BEHAVIORAL). 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.
What does Not Applicable mean for NCT06181253?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06181253?
This trial is currently "Terminated." It started on 2024-05-02. The estimated completion date is 2025-12-23.
Who is sponsoring NCT06181253?
NCT06181253 is sponsored by Boston Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06181253?
The trial aims to enroll 3 participants. The trial status is terminated.
How is NCT06181253 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06181253?
The primary outcome measures are: Baseline 6 minute walking test (6MWT) (Baseline (preoperatively)); Postoperative 6 minute walking test (6MWT) (Postoperative, 24-48 hours after surgery); Baseline Activity Measure for Post Acute Care (AMPAC) (Baseline (preoperatively)); Postoperative Activity Measure for Post Acute Care (AMPAC) (Postoperative, 24-48 hours after surgery); Baseline Frailty Scoring (Baseline (preoperatively)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06181253 being conducted?
This trial is being conducted at 1 site, including Boston, Massachusetts (United States).
Where can I find official information about NCT06181253?
The official record for NCT06181253 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06181253. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06181253 testing in simple terms?
This trial tests if simple exercises and reminders can help patients recover faster after surgery. It is for patients undergoing general surgery, colorectal, or surgical oncology procedures at Boston Medical Center.
Why is this trial significant?
This trial matters because it explores low-cost ways to help patients, especially those with fewer resources, recover better after surgery, addressing a gap in current prehabilitation programs.
What are the potential risks of participating in NCT06181253?
The main risks are related to the surgery itself, not the prehabilitation program. Some patients might experience muscle soreness from increased walking. There is a small risk of not being able to complete the walking goals due to personal circumstances. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06181253?
Ask your doctor if pre-surgery exercises are right for you and how they might help your specific surgery. You will receive instructions and daily text reminders to walk and track your steps. You will attend clinic visits before and after your surgery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06181253 signal from an investment perspective?
This trial investigates a low-cost intervention for a common surgical issue, potentially improving patient outcomes and reducing healthcare costs, though its termination suggests challenges in executi This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves attending clinic visits before and after surgery, and following a daily walking and text reminder program. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Post Operative Complications Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.