Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery

NCT ID: NCT07205393

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-10-20

Brief Summary

Cardiac rehabilitation is a crucial component of postoperative recovery for patients who have received valve replacement surgery. Aim: This study aimed to evaluate the effectiveness of phase one cardiac rehabilitation in improving cardiovascular function, pulmonary capacity, functional ability, and quality of life.

Detailed Description

A 60 patients aged 40 to 60 years who had received mitral or aortic valve replacement were allocated randomly into two groups equal in numbers, the first one (cardiac rehabilitation group) participated in a phase one cardiac rehabilitation program comprising supervised physical exercises and respiratory training, the second one (control group) underwent routine physical therapy program. The outcomes were oxygen saturation measurements, spirometry measures and Six minutes walk test. All measured variables were evaluated before and after six consecutive weeks of rehabilitation for all patients.

Conditions

Valve Replacement Surgery

Study Design

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

Study Groups

Cardiac rehabilitation

The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital.

The sessions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists, plus routine clinical care.

Group Type: OTHER

Cardiac rehabilitation

Intervention Type: OTHER

The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital.

The essions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists. Plus routine clinical care

Routine clinic care

Intervention Type: OTHER

The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).

Control group

The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).

Data collection The investigators assessed all patients on the day before surgery (baseline assessment) and the day of hospital discharge.

Group Type: OTHER

Routine clinic care

Intervention Type: OTHER

The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).

Interventions

Cardiac rehabilitation

The intervention group underwent the cardiac rehabilitation program from the first day following surgery regarding the clinical guideline for rehabilitation in patients with cardiovascular disease.17 This rehabilitation exercise program formed of breathing exercises, lower and upper extremity exercises in bed, sitting on the edge of the bed, standing at the bedside, and walking around the bed and for 100 m in the ward. The patient performed three sessions per day, with approximately 20 minutes each time. After the rehabilitation exercise, patients continued with gait practice for up to 500 m and carried out endurance training by using a stationary bike in the rehabilitation center of the hospital.

The essions continued until they were discharged from the hospital (approximately 5 to 6 days post operative). The intensity of physical activity was limited by clinical conditions and activity tolerance, and monitored and assessed by physical therapists. Plus routine clinical care

Intervention Type: OTHER

Routine clinic care

The control group did not joined any rehabilitation program and only received routine clinical care during the duration of the hospital stay (approximately 5 to 6 days post operative).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• and to be hemodynamically stable to qualify for a structured rehabilitation program.
• Being able to understand and complete measurements.
• And provide informed written consent.

Exclusion Criteria

• Patient with ischemic heart disease before surgery.
• Those with severe musculoskeletal system disorders.
• Patients who had persistent or paroxysmal atrial fibrillation.
• Individuals with severe heart failure.
• uncontrolled arrhythmias.
• Comorbidity complicating physical activity or other contraindications to phase one cardiac rehabilitation and Patients who underwent an emergency surgical intervention.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

South Valley University

OTHER

Sponsor Role: lead

Responsible Party

Shymaa yussuf abo zaid

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South valley university

Qina, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Shymaa Yussuf Abo-Zaid, Lecturer

Role: CONTACT

shaymaayoussef397@gmail.com

01010941685

Facility Contacts

Shymaa Yussuf Abo_Zaid, Lecturer

Role: primary

shaymaayoussef397@gmail.com

01010941685

Other Identifiers

P.T_INT_11/2024_553

Identifier Type: -

Identifier Source: org_study_id