Post Operative ComplicationsPrehabNCT06181253
The Impact of Prehabilitation
A study testing Preoperative education, Moderate aerobic exercise and Text messages in people with Post Operative Complications, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Post Operative Complications
- What is being tested?
- Preoperative education, Moderate aerobic exercise and Text messages
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2024to 23 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Prehabilitation Measures on Postoperative Outcomes
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.
Read more
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
- Being tested
- Preoperative education, Moderate aerobic exercise, Text messages, Pedometer
- Keywords
- Prehabilitation, Patient video education, Instructional walking video, 6 minute Walking test, Patient texting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative educationOther
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.
Moderate aerobic exerciseBehavioural
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)
Text messagesOther
Text reminders will be sent daily to remind patients to walk at home.
PedometerBehavioural
Participants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (3)
Readmission rate
Through chart review, the participants readmission rate back into the hospital (postoperatively) will be compared between the intervention and control group.
Measured: 8 weeks
Length of hospital stay
The number of days participants are hospitalized will be abstracted from the participants medical records.
Measured: 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.
Measured: 2 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start2 May 2024
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Why it stopped: Low recruitment yield, high participant burden, and concerns about the interventions so the study was stopped
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative ComplicationsStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Spence, MD, Principal investigator, Boston Medical Center, Anesthesiology Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181253
- Sponsor's protocol ID
- H-42768
- Acronym
- Prehab
- Status last verified
- Mar 2026
- First submitted
- 5 Dec 2023
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Prehabilitation Measures on Postoperative Outcomes
- ClinicalTrials.gov ID
- NCT06181253
- Acronym / sponsor ID
- Prehab / H-42768
- Conditions
- Post Operative Complications
- Keywords
- Prehabilitation, Patient video education, Instructional walking video, 6 minute Walking test, Patient texting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment yield, high participant burden, and concerns about the interventions so the study was stopped
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Experimental | Other: Preoperative education, Behavioral: Moderate aerobic exercise, Other: Text messages, Behavioral: PedometerWatch 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. |
| Control group | No intervention | –Receive the usual preoperative and post operative care and they will be provided a pedometer. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Limited/non readers (less than 5th grade reading level), assessed via comprehension of consent materials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative 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. | Other | Prehabilitation group |
| Moderate 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) | Behavioural | Prehabilitation group |
| Text messagesText reminders will be sent daily to remind patients to walk at home. | Other | Prehabilitation group |
| PedometerParticipants will be encouraged to walk 10,000 steps daily which will be tracked with a pedometer | Behavioural | Prehabilitation group |
Primary outcome
Baseline 6 minute walking test (6MWT)
Time frame: Baseline (preoperatively)
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 6 minute walking test (6MWT)
Time frame: Postoperative, 24-48 hours after surgery
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 Activity Measure for Post Acute Care (AMPAC)
Time frame: Baseline (preoperatively)
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 Activity Measure for Post Acute Care (AMPAC)
Time frame: Postoperative, 24-48 hours after surgery
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 Frailty Scoring
Time frame: Baseline (preoperatively)
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 Frailty Scoring
Time frame: Postoperative, 24-48 hours after surgery
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 John's Hopkins Highest Level of Mobility (JH-HLM) Scale
Time frame: Baseline (preoperatively)
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 John's Hopkins Highest Level of Mobility (JH-HLM) Scale
Time frame: Postoperative, 24-48 hours after surgery
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 Veterans Rand 12 (VR-12) Item Health Survey
Time frame: Baseline (preoperatively)
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 Veterans Rand 12 (VR-12) Item Health Survey
Time frame: Postoperative, 24-48 hours after surgery
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.
Adherence to mobility intervention assessed by text survey data
Time frame: 8 weeks
Participants will be asked daily regarding home activity level (minutes of walking per day) as a measure of adherence to prehabilitation walking program.
Adherence to mobility intervention assessed by pedometer step count
Time frame: 8 weeks
Participants will be asked daily about their pedometer step count as a measure of adherence to prehabilitation walking program.
3 secondary outcomes
Readmission rate
Time frame: 8 weeks
Length of hospital stay
Time frame: 6-8 weeks
Complications from surgery
Time frame: 2 months post surgery
Results and safety
The study was stopped early (reason given: Low recruitment yield, high participant burden, and concerns about the interventions so the study was stopped). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Spence, MD principal investigator
Boston Medical Center, Anesthesiology Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative education, Moderate aerobic exercise and Text messages in people with Post Operative Complications, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low recruitment yield, high participant burden, and concerns about the interventions so the study was stopped). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline 6 minute walking test (6MWT) (time frame: Baseline (preoperatively)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.