South valley university
Qina, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT07205393
Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery
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.
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Conditions
Age range
40 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- The inclusion criteria was elective mitral or aortic valve replacement
- 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.
Treatment and study plan
Cardiac rehabilitation
OtherThe 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
OtherThe 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).
Primary outcomes
-
Oxygen saturation.
Time frame: 5 to 6 days
Oxygen saturation: (2700 Branshaj, Denemark).
-
FVC
Time frame: 5 to 6 days
Forced vital capacity (FVC)
-
FEV1
Time frame: 5 to 6 days
forced expiratory volume in the first second (FEV1)
-
FEV1/FVC.
Time frame: 5 to 6 days
The ratio of FEV1 on FVC.
Secondary outcomes
-
The 6-Minute Walk Test (6MWT)
Time frame: 5 to 6 days
The 6-Minute Walk Test (6MWT): We performed the 6-minute walking test (6MWT), which involved measurement of the 6-minute walking distance and is a submaximal functional test indicative of performing daily activities.18 The safety and feasibility of this test have led to its use in cardiovascular rehabilitation.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
South Valley University
Other
Registry information
Important dates
- Study start
- 2025
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Oct 3, 2025
- Registry last updated
- Oct 3, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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