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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 below
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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.
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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 weeks
Treatment ~ Varies
Follow Up ~8 hours sleep, less than 3 awakenings
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hours sleep, less than 3 awakenings for reporting.

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

Media Library

Enhanced Physical Therapy Protocol Clinical Trial Eligibility Overview. Trial Name: NCT03806257 — N/A
Cardiac Rehabilitation Research Study Groups: Control, Enhanced Physical Therapy Protocol
Cardiac Rehabilitation Clinical Trial 2023: Enhanced Physical Therapy Protocol Highlights & Side Effects. Trial Name: NCT03806257 — N/A
Enhanced Physical Therapy Protocol 2023 Treatment Timeline for Medical Study. Trial Name: NCT03806257 — N/A

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."

Answered by AI
~6 spots leftby Jun 2024