Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery

NCT07205393 | Recruiting DMC

• 1 other identifier: P.T_INT_11/2024_553
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Valve Replacement Surgery

Keywords

Cardiac rehabilitation; Valve replacement; Spirometry measures

Outcome Measures

Primary Outcomes (4)

• Oxygen saturation.

  Oxygen saturation: (2700 Branshaj, Denemark).

  5 to 6 days

• FVC

  Forced vital capacity (FVC)

  5 to 6 days

• FEV1

  forced expiratory volume in the first second (FEV1)

  5 to 6 days

• FEV1/FVC.

  The ratio of FEV1 on FVC.

  5 to 6 days

Secondary Outcomes (1)

• The 6-Minute Walk Test (6MWT)

  5 to 6 days

Study Arms (2)

Cardiac rehabilitation

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 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.

Other: Cardiac rehabilitation; Other: Routine clinic care

Control group

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

Other: Routine clinic care

Interventions

Cardiac rehabilitation 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

Cardiac rehabilitation

Routine clinic care 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).

Cardiac rehabilitation; Control group

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

South valley university

Qina, Egypt

RECRUITING

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Shymaa Yussuf Abo-Zaid, Lecturer

CONTACT

01010941685; shaymaayoussef397@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: October 3, 2025
• Study Start: January 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 20, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)