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Enhanced Physical Therapy for Cardiac Surgery Recovery
N/A
Waitlist Available
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults 18 years or older undergoing combined CABG with one or more valve repair or replacement surgery
Adults 18 years or older undergoing scheduled, elective coronary artery bypass graft (CABG) surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hours sleep, less than 3 awakenings
Awards & highlights
Study Summary
This trial is testing whether an enhanced post-operative physical therapy protocol can decrease ICU and hospital length of stay for people who have had certain cardiac surgeries.
Who is the study for?
This trial is for adults over 18 who are scheduled for elective heart surgery, like bypass or valve repair. It's not open to pregnant women, prisoners, those with skin infections or allergies to polyurethane, paraplegics/quadriplegics, and anyone with major perioperative complications.Check my eligibility
What is being tested?
The study tests an enhanced physical therapy protocol after heart surgery against the standard care. The new approach includes early and frequent movement plus patient education. Participants will wear a FitBit to track activity and sleep quality post-surgery.See study design
What are the potential side effects?
Since this trial involves physical therapy rather than medication, side effects may include typical risks associated with exercise post-surgery such as discomfort or fatigue. However, specific side effects will depend on individual health conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult scheduled for heart surgery that includes bypass and valve repair or replacement.
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I am an adult scheduled for elective heart bypass surgery.
Select...
I am an adult scheduled for mitral valve surgery.
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I am 18 or older and will have surgery on my aortic valve.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 hours sleep, less than 3 awakenings
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hours sleep, less than 3 awakenings
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Shorter Hospital Length of Stay
Shorter ICU Length of Stay
Secondary outcome measures
Composite Clinical Outcome
Longer sleep duration with fewer awakenings
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced Physical Therapy ProtocolExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,047,879 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had serious complications during or after surgery.I am an adult scheduled for heart surgery that includes bypass and valve repair or replacement.I am paraplegic or quadriplegic.I am an adult scheduled for elective heart bypass surgery.I have a skin or systemic infection.I am an adult scheduled for mitral valve surgery.I am 18 or older and will have surgery on my aortic valve.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Enhanced Physical Therapy Protocol
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor have any current vacancies for participants?
"The clinical trial, originally posted in March of 2018 and last updated on December 13th 2021, is not currently looking for participants. However, there are presently 15 other trials that require enrolment."
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