Cardiac RehabilitationNCT03806257
Patient Mobility and Outcomes After Cardiac Surgery
A study testing Enhanced Physical Therapy Protocol in people with Cardiac Rehabilitation, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
Standards for post-cardiac surgery physical interventions vary between insitutions and there are no published guidelines for national organizations in the U.S. The increasing body of evidence for the effectiveness of physical interventions coupled with variability in how these interventions are implemented suggests a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiac Rehabilitation
- What is being tested?
- Enhanced Physical Therapy Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2018to 30 Jun 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft (CABG) surgery, mitral valve repair or replacement surgery, aortic valve repair or replacement surgery and combined CABG with one or more valve repair or replacement surgery.
Who cannot join
- Those who do not med the inclusion criteria
- Pregnant women
- Prisoners
- Those patients with skin or systemic infections
- Those patients who are paraplegic or quadriplegic
- Those patients who have allergies to polyurethane
- Any patient who experiences perioperative complications (e.g., stroke, myocardial infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient Mobility and Outcomes After Cardiac Surgery: a Randomized Controlled Trial
Standards for post-cardiac surgery physical interventions vary between insitutions and there are no published guidelines for national organizations in the U.S. The increasing body of evidence for the effectiveness of physical interventions coupled with variability in how these interventions are implemented suggests a critical need to prospectively determine the impact of clearly defined postoperative physical interventions. This randomized, controlled study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and ambulation, and 3) patient education on the outcomes of hospital lengths of stay and discharge disposition. The investigators will enroll 220 adult subjects undergoing elective CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care) group or intervention group (enhanced protocol), and followed for five days. Subjects in each group will wear a FitBit Charge 2 for the duration of the five days following surgery. This will provide both sleep activity and steps data that will be analyzed for sleep quality and distance walked. The primary aim is to assess the difference between groups for ICU and hospital length of stay.
Read the detailed description
Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study staff will visit potential study subjects in the pre-surgical testing clinic to discuss the study's objectives and to ascertain subjects' interest in participating in the study. After providing informed consent, subjects will be randomized using SAS into either the interventional group or standard care group after their surgical procedure is complete and the subject has been transferred to the CVICU. After completion of the surgical procedure, patients who had a major perioperative complication such as stroke, myocardial infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen failures and will not be randomized, since the investigators consider the patient enrolled once randomized. Patients randomized to the interventional group will undergo the enhanced physical therapy protocol which includes mobilization from bed to chair on the day of surgery and more frequent ambulation on the subsequent five days.
The main differences between the standard therapy (control) group and intervention group is the timing of post-operative mobilization and ambulation, as well as the point at which they receive gait and safe ambulation training. In the standard therapy group, the patients will receive a FitBit2 after their arrival on the ICU, withstanding any postoperative complications. On POD 1 the subjects routinely get up to the bedside chair with the help of an ICU nurse or physical therapist. The subjects will generally ambulate one-half the circumference of the ICU with assistance, though this is not enforced. On POD2 and onward, the standard therapy group typically will get up to the bedside chair at least once, as well as walk one-half circumference of the ICU, and will receive the standard physical therapy gait and ambulation training. The intervention group will have the FitBit2 watch placed on their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will get up to the bedside chair twice (as tolerated by patient), and will be asked to walk one-half the ICU circumference. Additionally, the patient's physical therapy and gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the bedside chair three times, and will be asked to attempt three walks with the goal of one full ICU circumference.
- Conditions
- Cardiac Rehabilitation
- Being tested
- Enhanced Physical Therapy Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Physical Therapy ProtocolOther
A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Subjects in the control arm will receive standard of care, which consists of mobilization to a bedside chair at least once, and ambulate one-half ICU circumference on postoperative day one. On postoperative days two through five, the subject will be mobilized to the bedside chair at least once, and ambulated at least once with target of one full ICU circumference. These subjects will receive gait training and safe ambulation education, and wear a FitBit Charge 2 watch for five days after surgery. |
| Enhanced Physical Therapy Protocol | Experimental | Subjects in the experimental arm will recieve a FitBit Charge 2 watch, and will be mobilized to the bedside chair on postoperative day zero. On postoperative day two subjects will be mobilized to the bedside chair twice, ambulate one-half of the ICU circumference, and receive gait and safe ambulation training. On postoperative days two through five, subjects will mobilize to the bedside chair three times, and will be encouraged to ambulate three times, each time with a target of one full ICU circumference. Receives: Other: Enhanced Physical Therapy Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shorter ICU Length of Stay
Decrease days in ICU from average standard-of-care patient
Measured: 1.2 days
Shorter Hospital Length of Stay
Decrease days in hospital from average standard-of-care patient
Measured: 2 days
Secondary outcomes (2)
Composite Clinical Outcome
Combined incidence of pulmonary atelectasis, pneumonia, venous thromboembolism, pulmonary embolism, and mortality.
Measured: 5 days
Longer sleep duration with fewer awakenings
Sleep time that is longer than average standard-of-care patient
Measured: 8 hours sleep, less than 3 awakenings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start28 Mar 2018
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac RehabilitationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled prospective design involving two study groups: 1) standard-of-care for cardiac physical therapy, and 2) enhanced protocol for cardiac physical therapy. Primary aim is to assess difference, if any, between groups for ICU and hospital length of stay.
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sreekanth Cheruku, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806257
- Sponsor's protocol ID
- STU 012018-090
- Status last verified
- Oct 2024
- First submitted
- 14 Jan 2019
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share data with any outside entity or non-IRB-approved personnel.
Publications
Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.
PubMed 18716482
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Mobility and Outcomes After Cardiac Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03806257
- Acronym / sponsor ID
- STU 012018-090
- Conditions
- Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2018 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 16 Jan 2019 (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.
Standards for post-cardiac surgery physical interventions vary between insitutions and there are no published guidelines for national organizations in the U.S. The increasing body of evidence for the effectiveness of physical interventions coupled with variability in how these interventions are implemented suggests a critical need to prospectively determine the impact of clearly defined postoperative physical interventions. This randomized, controlled study seeks to determine the effectiveness of a three-pronged, enhanced, post-operative physical therapy protocol which includes 1) early mobilization, 2) frequent mobilization and ambulation, and 3) patient education on the outcomes of hospital lengths of stay and discharge disposition. The investigators will enroll 220 adult subjects undergoing elective CABG, mitral valve repair or replacement surgery, aortic valve surgery, or combined CABG/valve procedures. Subjects will be randomized to either the control (standard-of-care) group or intervention group (enhanced protocol), and followed for five days. Subjects in each group will wear a FitBit Charge 2 for the duration of the five days following surgery. This will provide both sleep activity and steps data that will be analyzed for sleep quality and distance walked. The primary aim is to assess the difference between groups for ICU and hospital length of stay.
Detailed description
Patients will be identified based on pre-screening the cardiothoracic surgery schedule. Study staff will visit potential study subjects in the pre-surgical testing clinic to discuss the study's objectives and to ascertain subjects' interest in participating in the study. After providing informed consent, subjects will be randomized using SAS into either the interventional group or standard care group after their surgical procedure is complete and the subject has been transferred to the CVICU. After completion of the surgical procedure, patients who had a major perioperative complication such as stroke, myocardial infarction, pulmonary embolism, hemorrhage requiring massive transfusion (>10 units of PRBCs), intraoperative cardiac arrest, or intraoperative pulmonary arrest, will be considered screen failures and will not be randomized, since the investigators consider the patient enrolled once randomized. Patients randomized to the interventional group will undergo the enhanced physical therapy protocol which includes mobilization from bed to chair on the day of surgery and more frequent ambulation on the subsequent five days.
The main differences between the standard therapy (control) group and intervention group is the timing of post-operative mobilization and ambulation, as well as the point at which they receive gait and safe ambulation training. In the standard therapy group, the patients will receive a FitBit2 after their arrival on the ICU, withstanding any postoperative complications. On POD 1 the subjects routinely get up to the bedside chair with the help of an ICU nurse or physical therapist. The subjects will generally ambulate one-half the circumference of the ICU with assistance, though this is not enforced. On POD2 and onward, the standard therapy group typically will get up to the bedside chair at least once, as well as walk one-half circumference of the ICU, and will receive the standard physical therapy gait and ambulation training. The intervention group will have the FitBit2 watch placed on their wrist on POD 0, along with getting up to the bedside chair. On POD 1, the subjects will get up to the bedside chair twice (as tolerated by patient), and will be asked to walk one-half the ICU circumference. Additionally, the patient's physical therapy and gait/ambulation training will commence on POD 1. On POD 2, the subjects will get up to the bedside chair three times, and will be asked to attempt three walks with the goal of one full ICU circumference.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled prospective design involving two study groups: 1) standard-of-care for cardiac physical therapy, and 2) enhanced protocol for cardiac physical therapy. Primary aim is to assess difference, if any, between groups for ICU and hospital length of stay.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Subjects in the control arm will receive standard of care, which consists of mobilization to a bedside chair at least once, and ambulate one-half ICU circumference on postoperative day one. On postoperative days two through five, the subject will be mobilized to the bedside chair at least once, and ambulated at least once with target of one full ICU circumference. These subjects will receive gait training and safe ambulation education, and wear a FitBit Charge 2 watch for five days after surgery. |
| Enhanced Physical Therapy Protocol | Experimental | Other: Enhanced Physical Therapy ProtocolSubjects in the experimental arm will recieve a FitBit Charge 2 watch, and will be mobilized to the bedside chair on postoperative day zero. On postoperative day two subjects will be mobilized to the bedside chair twice, ambulate one-half of the ICU circumference, and receive gait and safe ambulation training. On postoperative days two through five, subjects will mobilize to the bedside chair three times, and will be encouraged to ambulate three times, each time with a target of one full ICU circumference. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft (CABG) surgery, mitral valve repair or replacement surgery, aortic valve repair or replacement surgery and combined CABG with one or more valve repair or replacement surgery.
Key exclusion criteria (7 listed)
- Those who do not med the inclusion criteria
- Pregnant women
- Prisoners
- Those patients with skin or systemic infections
- Those patients who are paraplegic or quadriplegic
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 |
|---|---|---|
| Enhanced Physical Therapy ProtocolA structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient. | Other | Enhanced Physical Therapy Protocol |
Primary outcome
Shorter ICU Length of Stay
Time frame: 1.2 days
Decrease days in ICU from average standard-of-care patient
Shorter Hospital Length of Stay
Time frame: 2 days
Decrease days in hospital from average standard-of-care patient
2 secondary outcomes
Composite Clinical Outcome
Time frame: 5 days
Longer sleep duration with fewer awakenings
Time frame: 8 hours sleep, less than 3 awakenings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 18716482Herdy AH, Marcchi PL, Vila A, Tavares C, Collaco J, Niebauer J, Ribeiro JP. Pre- and postoperative cardiopulmonary rehabilitation in hospitalized patients undergoing coronary artery bypass surgery: a randomized controlled trial. Am J Phys Med Rehabil. 2008 Sep;87(9):714-9. doi: 10.1097/PHM.0b013e3181839152.
- Individual participant dataSharing planned: No. We will not share data with any outside entity or non-IRB-approved personnel.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Physical Therapy Protocol in people with Cardiac Rehabilitation, run by University of Texas Southwestern 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 1 inclusion and 7 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: finished, as of the sponsor's last update on 4 Oct 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Shorter ICU Length of Stay (time frame: 1.2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03806257, which also lists 1 linked publication.
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 4 Oct 2024.