Effect of Cardiac Rehabilitation on Health Status, Emotional Outcomes, and 90-day Readmission Rate Among Cardiac Surgery Patients

NCT ID: NCT06118918

Last Updated: 2024-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-03
• Study Completion Date: 2024-08-01

Brief Summary

this study aims to investigate the effect of the cardiac rehabilitation program on perceived health, status, anxiety, depression, and 90-day readmission rates for post-cardiac surgery patients. The participants in this study will be randomly allocated to either an experimental or control group, the experimental group will receive the cardiac rehabilitation programThe cardiac rehabilitation program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. All content will delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. Health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation..etc. Stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA)..All potential participants will be assessed before being involved in the study. assessment including a general physical examination, inspection of the surgical site, and recent history for potential patient symptoms after discharge, such as chest pain, palpitation, fatigue, or dyspnea. The assessment includes electrocardiograph (ECG), blood samples, and echocardiography analyses. Based on the findings of this assessment, patients will be classified by the cardiologist as either grade I, II, III, or IV, according to the New York Heart Association (NYHA) Classification. Patients who will be eligible to participate in the present study should be grade I or II in the NYHA Classification for dyspnea. Participants in the control group will receive the usual care (general instructions and advice from physicians and nurses). All materials will be delivered to all participants after completing the study.

Conditions

Health Status; Anxiety; Depression; 90-day Readmission

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

The interventional arm (participants who will received the cardiac rehabilitation program

this arm will receive the cardiac rehabilitation program after completing the cardiac surgery and being assessed for eligibility.

Group Type: EXPERIMENTAL

Phase II comprehensive cardiac rehabilitation program

Intervention Type: BEHAVIORAL

the program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. all content will be delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation …etc. stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. Phone call follow-ups once weekly will be made by one of the research team to evaluate the adherence and answer potential questions All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA

the control arm (who will receive the usual care)

the control group will receive the usual care ( the usual instruction and general advice from the physicians and the nurses)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phase II comprehensive cardiac rehabilitation program

the program extends over 3 months after cardiac surgery. The program includes exercise, health education, and stress management. all content will be delivered to the participants through the WhatsApp application as instruction videos and short lectures. exercise will be gradually increased in terms of intensity, and duration. health education will cover topics like a healthy diet blood pressure, blood cholesterol control, smoking cessation …etc. stress management will include relaxation therapy, breathing control, behavioral change, and other strategies to control stress. Phone call follow-ups once weekly will be made by one of the research team to evaluate the adherence and answer potential questions All interventions are guided by universal guidelines like the Australian Cardiovascular Health and Rehabilitation Association (ACRA) and American Heart Association (AHA

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. . aged over 18 years.

2. underwent cardiac surgery.

3. classified as grade I or II according to NYHA classification of dyspnea by the physician.

4. does not complain of any physical or mental condition preventing him or her from participating.

5. agree to participate in the study.

Exclusion Criteria

1. aged under 18 years.

2. classified as grade III or IV according to NYHA classification of dyspnea by the physician.

3. complain of any physical or mental condition preventing him or her from participating.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Putra Malaysia

OTHER

Sponsor Role: lead

Responsible Party

ALI SULEIMAN HARBI

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

ALI SU HARBI

Role: PRINCIPAL_INVESTIGATOR

University Putra Malaysia

Locations

Prince Hamzah hospital

Amman, , Jordan

Countries

Jordan

Other Identifiers

9771044993

Identifier Type: -

Identifier Source: org_study_id