- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07438717
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- 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
-
-
Punjab Province
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
Duration: The program lasted 12 weeks with 3 sessions per week. Session Structure:
Exercise Type:
|
|
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.
|
Duration: The program lasted 12 weeks with 3 sessions per week. Session Structure:
Exercise Type:
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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
- Hensey M, Brown RA, Lal S, Sathananthan J, Ye J, Cheung A, Blanke P, Leipsic J, Moss R, Boone R, Webb JG. Transcatheter Mitral Valve Replacement: An Update on Current Techniques, Technologies, and Future Directions. JACC Cardiovasc Interv. 2021 Mar 8;14(5):489-500. doi: 10.1016/j.jcin.2020.12.038. Epub 2021 Mar 1.
- Goode D, Dhaliwal R, Mohammadi H. Transcatheter Mitral Valve Replacement: State of the Art. Cardiovasc Eng Technol. 2020 Jun;11(3):229-253. doi: 10.1007/s13239-020-00460-4. Epub 2020 Mar 4.
- Simonato M, Whisenant B, Ribeiro HB, Webb JG, Kornowski R, Guerrero M, Wijeysundera H, Sondergaard L, De Backer O, Villablanca P, Rihal C, Eleid M, Kempfert J, Unbehaun A, Erlebach M, Casselman F, Adam M, Montorfano M, Ancona M, Saia F, Ubben T, Meincke F, Napodano M, Codner P, Schofer J, Pelletier M, Cheung A, Shuvy M, Palma JH, Gaia DF, Duncan A, Hildick-Smith D, Veulemans V, Sinning JM, Arbel Y, Testa L, de Weger A, Eltchaninoff H, Hemery T, Landes U, Tchetche D, Dumonteil N, Rodes-Cabau J, Kim WK, Spargias K, Kourkoveli P, Ben-Yehuda O, Teles RC, Barbanti M, Fiorina C, Thukkani A, Mackensen GB, Jones N, Presbitero P, Petronio AS, Allali A, Champagnac D, Bleiziffer S, Rudolph T, Iadanza A, Salizzoni S, Agrifoglio M, Nombela-Franco L, Bonaros N, Kass M, Bruschi G, Amabile N, Chhatriwalla A, Messina A, Hirji SA, Andreas M, Welsh R, Schoels W, Hellig F, Windecker S, Stortecky S, Maisano F, Stone GW, Dvir D. Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry. Circulation. 2021 Jan 12;143(2):104-116. doi: 10.1161/CIRCULATIONAHA.120.049088. Epub 2020 Sep 25.
- Guerrero M, Vemulapalli S, Xiang Q, Wang DD, Eleid M, Cabalka AK, Sandhu G, Salinger M, Russell H, Greenbaum A, Kodali S, George I, Dvir D, Whisenant B, Russo MJ, Pershad A, Fang K, Coylewright M, Shah P, Babaliaros V, Khan JM, Tommaso C, Saucedo J, Kar S, Makkar R, Mack M, Holmes D, Leon M, Bapat V, Thourani VH, Rihal C, O'Neill W, Feldman T. Thirty-Day Outcomes of Transcatheter Mitral Valve Replacement for Degenerated Mitral Bioprostheses (Valve-in-Valve), Failed Surgical Rings (Valve-in-Ring), and Native Valve With Severe Mitral Annular Calcification (Valve-in-Mitral Annular Calcification) in the United States: Data From the Society of Thoracic Surgeons/American College of Cardiology/Transcatheter Valve Therapy Registry. Circ Cardiovasc Interv. 2020 Mar;13(3):e008425. doi: 10.1161/CIRCINTERVENTIONS.119.008425. Epub 2020 Mar 6.
- Jafri SH, Hushcha P, Dorbala P, Bousquet G, Lutfy C, Klein J, Mellett L, Sonis L, Polk D, Skali H. Physical and Psychological Well-being Effects of Cardiac Rehabilitation on Patients Following Mitral Valve and Aortic Valve Procedures. J Cardiopulm Rehabil Prev. 2022 Mar 1;42(2):90-96. doi: 10.1097/HCR.0000000000000609.
- Xue W, Xinlan Z, Xiaoyan Z. Effectiveness of early cardiac rehabilitation in patients with heart valve surgery: a randomized, controlled trial. J Int Med Res. 2022 Jul;50(7):3000605211044320. doi: 10.1177/03000605211044320.
- Leal JM, Galliano LM, Del Vecchio FB. Effectiveness of High-Intensity Interval Training Versus Moderate-Intensity Continuous Training in Hypertensive Patients: a Systematic Review and Meta-Analysis. Curr Hypertens Rep. 2020 Mar 3;22(3):26. doi: 10.1007/s11906-020-1030-z.
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)
February 10, 2024
Primary Completion (Actual)
January 5, 2025
Study Completion (Actual)
January 5, 2025
Study Registration Dates
First Submitted
February 23, 2026
First Submitted That Met QC Criteria
February 26, 2026
First Posted (Actual)
February 27, 2026
Study Record Updates
Last Update Posted (Actual)
February 27, 2026
Last Update Submitted That Met QC Criteria
February 26, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Other Study ID 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.
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