Valve Replacement SurgeryNCT07205393
Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery
A study testing Cardiac rehabilitation and Routine clinic care in people with Valve Replacement Surgery, run by South Valley University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years
- Conditions the study is for
- Valve Replacement Surgery
- What is being tested?
- Cardiac rehabilitation and Routine clinic care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
South valley university
Qina
Shymaa Yussuf Abo_Zaid, Lecturer, 01010941685, shaymaayoussef397@gmail.com
About this study
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.
Read the 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
- Being tested
- Cardiac rehabilitation, Routine clinic care
- Keywords
- Cardiac rehabilitation, Valve replacement, Spirometry measures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationOther
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 careOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Routine clinic care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen saturation.
Oxygen saturation: (2700 Branshaj, Denemark).
Measured: 5 to 6 days
FVC
Forced vital capacity (FVC)
Measured: 5 to 6 days
FEV1
forced expiratory volume in the first second (FEV1)
Measured: 5 to 6 days
FEV1/FVC.
The ratio of FEV1 on FVC.
Measured: 5 to 6 days
Secondary outcomes (1)
The 6-Minute Walk Test (6MWT)
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.
Measured: 5 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Jan 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shymaa yussuf abo zaid, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205393
- Sponsor's protocol ID
- P.T_INT_11/2024_553
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I will not share it outside the primary research group.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase One Cardiac Rehabilitation Outcomes Post Valve Replacement Surgery
- ClinicalTrials.gov ID
- NCT07205393
- Acronym / sponsor ID
- P.T_INT_11/2024_553
- Conditions
- Valve Replacement Surgery
- Keywords
- Cardiac rehabilitation, Valve replacement, Spirometry measures
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- First posted
- 3 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation | Other | Other: Cardiac rehabilitation, Other: Routine clinic careThe 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. |
| Control group | Other | Other: Routine clinic careThe 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. |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationThe 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 | Other | Cardiac rehabilitation |
| Routine clinic careThe 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). | Other | Cardiac rehabilitation, Control group |
Primary outcome
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.
1 secondary outcome
The 6-Minute Walk Test (6MWT)
Time frame: 5 to 6 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: No. I will not share it outside the primary research group.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac rehabilitation and Routine clinic care in people with Valve Replacement Surgery, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shymaa Yussuf Abo-Zaid, Lecturer (01010941685, shaymaayoussef397@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen saturation. (time frame: 5 to 6 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.