- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07724353
Early Cardiopulmonary Rehabilitation Bundle Functional Capacity and Outcomes of Cardiac Surgeries Patients
Early Cardiopulmonary Rehabilitation Bundle: Its' Effect On Functional Capacity and Outcomes of Cardiac Surgeries Patients
The goal of this quasi-experimental study is to evaluate the impact of Early. Cardiopulmonary Rehabilitation Bundle on Functional Capacity and Outcomes in Cardiac Surgeries Patients The main question is Patients receive early cardiopulmonary rehabilitation bundle will.
affect or not functional capacity and not decrease negative outcomes. postoperative? Researchers will compare the effect on 140 patients divided into 2. groups (70 patients in study group and 70 patients in control group)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Taha HM Ibrahim, MSc
- Phone Number: 201091084749
- Email: tahahussien@nursing.aun.edu.eg
Study Contact Backup
- Name: mona AM Mohamed, PhD
- Phone Number: 2012261644645
Study Locations
-
-
-
Asyut, Egypt, 71515
- Assiut University Heart Hospital , Assiut University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient aged 18-65 years
- patient hemodynamically stable postoperative
- patient voluntarily participates in study
Exclusion Criteria:
- re-operative cardiac surgery
- patients with arrhythmia in operation room
- non elective cardiac surgery
- EURO categories 3 and 4
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: cardiopulmonary rehabilitation
study group Early cardiopulmonary rehabilitation will be apply on study group for improving functional capacity and reducing negative outcome postoperatively
|
The bundle include all of following :
|
|
Placebo Comparator: routine rehabilitation
control group will receive the routine postoperative ICU rehabilitation care
|
The bundle include all of following :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
physical activity
Time Frame: From study enrollment up t o7 days after surgery
|
evaluate the impact of Early Cardiopulmonary Rehabilitation Bundle on physical activity Postoperatively will be assess by using Functional exercise capacity tool which is assess the level of patients physical exertion postoperatively
|
From study enrollment up t o7 days after surgery
|
|
complications
Time Frame: From study enrollment up t o7 days after surgery
|
evaluate the impact of Early Cardiopulmonary Rehabilitation Bundle occurrence of complications postoperative will be assess by using patient outcomes tool
|
From study enrollment up t o7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
patient psychological status in ICU postoperative
Time Frame: From study enrollment up t o7 days after surgery
|
the outcome will be assess by using Quality of life questionnaire which is screening tool for depressive symptoms.
Scores of 5-9, 10-14, 15-19, and ≥20 indicate mild, moderate, moderately severe, and severe depression
|
From study enrollment up t o7 days after surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1120261460
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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