Comparative Effects of MIIT With CT In Post-MVR Surgery Patients (NCT07438717) | Clinical Trial Compass
CompletedNot Applicable
Comparative Effects of MIIT With CT In Post-MVR Surgery Patients
Pakistan56 participantsStarted 2024-02-10
Plain-language summary
Mitral Valve Replacement (MVR) surgery is commonly performed to treat patients with severe mitral valve diseases, such as mitral stenosis or regurgitation. Patients after mitral valve replacement surgery often experience muscular weakness ,fatigue and reduced functional capacity due to the surgical procedure and the time period of post-operative recovery. A structured exercise program helps rebuild strength and regain mobility, allowing patients to perform daily activities with greater ease and independence. Moderate-intensity interval training (MIIT) with continuous training is crucial for patients after mitral valve replacement (MVR) surgery, as it significantly enhances cardiopulmonary fitness. But the comparative effects of Moderate-intensity interval training (MIIT) with continuous training have not been well documented and practiced in Pakistan. The study aims to determine the comparative effects of Moderate-intensity interval training (MIIT) and moderate continuous training on physical capacity, cardiac efficiency, pulmonary function, and quality of life after mitral valve surgery. The study will be single blinded, randomized clinical trial. Based on inclusion and exclusion criteria patients were divided into two groups. The MIIT group and MICT group. The study was of 12 weeks session, 3 sessions per week (3 months). The data was analyzed through SPSS-23. Outcome measures were pulmonary function tests (spirometery), 6-Minute Walk Test (6MWT) and quality of life assessed through IPAQ. Cardiac efficiencywas measured by evaluating heart rate recovery, exercise tolerance, and cardiac output.
Who can participate
Age range
40 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Both male and female age 40-60 years
* Hemodynamically stable heart rate and blood pressure
* Patients 4-8 weeks post-mitral valve replacement (MVR) surgery
* Stable medical condition for MIIT
* Able to walk independently for at least 5 minutes without assistance
* Stable pulmonary function without severe pulmonary complications (e.g., severe chronic obstructive pulmonary disease).
* No ongoing respiratory infections or severe heart failure.
Exclusion Criteria:
* Presence of unstable angina, severe heart failure (ejection fraction \< 30%), or other significant cardiac arrhythmias that contraindicate exercise.
* Conditions that limit mobility or the ability to perform exercises safely (e.g., severe arthritis, recent fractures, or neuromuscular diseases).
* Patients with severe respiratory conditions (e.g., severe asthma or COPD exacerbation) that would limit participation in exercise.
* Other serious co-morbidities (e.g., uncontrolled diabetes, severe hypertension, renal failure) that may impact safe participation in exercise.
* Participation in any other structured exercise program
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.