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

February 26, 2026 updated by: Riphah International University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
56

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 42000
        • PIC Hospital, Lahore.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Group A: Moderate-Intensity Interval Training (MIIT)
Following the consent of the participants, heart rate (HR), blood pressure, and oxygen saturation baseline measurements were taken through six minutes' walk test. The program included patient counseling on the treatment intervention and right technique, such as regular breathing patterns and avoiding breath-holding. Each session lasted 60 minutes. The targeted muscles included the biceps, triceps, and deltoids in the upper limbs, and the quadriceps, hamstrings, and calf muscles in the lower limbs, using exercises with sandbags. Exercise dosage was progressed by increasing the resistance and repetitions. Load increases were made by 5% once the participant could comfortably achieve the upper limit of the prescribed range. The protocol took total 12 weeks, with 3 sessions per week.
Other: Moderate-Intensity Interval Training (MIIT)

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.
Experimental: Group B: Moderate-Intensity Continuous Training (MICT)
Following the consent of the participants, heart rate (HR), blood pressure, and oxygen saturation baseline measurements were taken through six minutes' walk test. The program included patient counseling on the treatment intervention and right technique, such as regular breathing patterns and avoiding breath-holding. Each session lasted 60 minutes. The targeted muscles included the biceps, triceps, and deltoids in the upper limbs, and the quadriceps, hamstrings, and calf muscles in the lower limbs, using exercises with sandbags. Exercise dosage was progressed by increasing the resistance and repetitions. Load increases were made by 5% once the participant could comfortably achieve the upper limit of the prescribed range. The protocol took total 12 weeks, with 3 sessions per week.
Other: Moderate-Intensity Continuous Training (MICT)

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
12 week
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.
12 week
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.
12 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hafiza Muriam Ghani, MS-CPPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR&AHS/24/0385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings