Clinical trial NCT06118918: Effect of Cardiac Rehabilitation on Health Status, Emotional Outcomes, and 90-day Readmission Rate Among Cardiac Surgery Patients
Official title: Impact of Rehabilitation on Anxiety, Depression, Perceived Health Status, and Readmission Among Patients After Coronary Artery Bypass in Jordan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Status
Anxiety
Depression
90-day Readmission
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Perceived health status
timeFrame: At base-line, after 12 weeks , and 1 month later
measure: Anxiety level
timeFrame: At base-line, after 12 weeks, and 1 month later
measure: Depression
timeFrame: At base-line, after 12 weeks , and 1 month later
measure: 90-day readmission rate
timeFrame: after90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Prince Hamzah hospital
Study officials:
affiliation: University Putra Malaysia
name: ALI SU HARBI
role: PRINCIPAL_INVESTIGATOR
References: