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NCT Number: NCT07438717

Comparative Effects of MIIT With CT In Post-MVR Surgery Patients

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.

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Key information

Conditions

Mitral Valve Replacement

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PIC Hospital, Lahore.

Lahore, Punjab Province, 42000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moderate-Intensity Interval Training (MIIT)

Other

Duration: The program lasted 12 weeks with 3 sessions per week.

Session Structure:

  • Each session lasted 20-45 minutes.
  • Exercise intensity was set at 50-70% of maximum heart rate (MHR).
  • Intervals consisted of 1-4 minutes of moderate-intensity exercise, followed by shorter rest periods of 1-2 minutes.

Exercise Type:

  • Alternating aerobic activities targeting both upper and lower body, such as treadmill and walking.
  • A warm-up (5-10 minutes) and cool-down (5-10 minutes) with light stretching and low-intensity walking were included.

Moderate-Intensity Continuous Training (MICT)

Other

Duration: The program lasted 12 weeks with 3 sessions per week.

Session Structure:

  • Each session lasted 30-60 minutes at a steady moderate intensity.
  • Exercise intensity was maintained at 50-70% of MHR without interruptions.

Exercise Type:

  • Continuous aerobic activity, such as walking on a treadmill.
  • A warm-up (5-10 minutes) and cool-down (5-10 minutes) were included.

Primary outcomes

  1. 6MWT

    Time frame: 12 week

    The 6-Minute Walk Test (6MWT) is a functional exercise capacity test which is validated and is able to measure a patient's walking ability for six minutes considering the maximum distance covered. It reflects the capacity for aerobic activity and endurance which is why it is mostly used in cardiac rehabilitation. The test is straightforward, cheap and requires no special equipment in a doctor's office. The reliability of the 6MWT

  2. Digital Spirometer

    Time frame: 12 week

    Spirometry is a common and essential pulmonary function test that measures the volume of air a person can inhale and exhale, as well as how quickly they can do so. It helps in diagnosing and monitoring respiratory diseases, such as asthma, chronic obstructive pulmonary disease (COPD), and other conditions that affect lung function. The reliability is usually good with test results reproducibility generally being above 90%. The validity is also well-defined since spirometry is rated as gold standard of measuring the lung functioning.

  3. VO₂ Peak

    Time frame: 12 weeks

    Cardiac Efficiency is defined as the heart's capability to pump blood in a manner that requires the least possible effort and still guarantees the tissues receive a good supply of oxygen. The most important indicator of cardiac efficiency is Peak Oxygen Uptake (VO₂ Peak) which comes from a cardiopulmonary exercise test (CPET) that is done under controlled conditions.

  4. IPAQ

    Time frame: 12 weeks

    The IPAQ (International Physical Activity Questionnaire) is the tool that is mostly adopted to evaluate quality of life via physical activity assessment. The IPAQ is made up of 7 queries which ask about the duration of the physical activities, very light to heavy, that happened in the last 7 days

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects Of Moderate Intensity Interval Training With Continuous Training On Physical Capacity, Pulmonary Functions, Cardiac Efficiency And Quality Of Life In Post Mitral Valve Replacement Surgery Patients

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

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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