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Mitral Valve ReplacementNCT07438717

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

A study testing Moderate-Intensity Interval Training (MIIT) and Moderate-Intensity Continuous Training (MICT) in people with Mitral Valve Replacement, run by Riphah International University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Mitral Valve Replacement
What is being tested?
Moderate-Intensity Interval Training (MIIT) and Moderate-Intensity Continuous Training (MICT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 sitePakistan
Study dates
10 Feb 2024to 5 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • PIC Hospital, Lahore.

    Lahore, Punjab Province, 42000

Other trials in Pakistan

About this study

Official 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

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.

Being tested
Moderate-Intensity Interval Training (MIIT), Moderate-Intensity Continuous Training (MICT)
Keywords
Cardiac efficiency, continuous training, mitral valve replacement, moderate-intensity interval training, physical capacity, pulmonary function, quality of life

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.
Study groups in NCT07438717
Study groupRoleWhat they receive
Group A: Moderate-Intensity Interval Training (MIIT)ExperimentalFollowing 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.
Receives: Other: Moderate-Intensity Interval Training (MIIT)
Group B: Moderate-Intensity Continuous Training (MICT)ExperimentalFollowing 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.
Receives: Other: Moderate-Intensity Continuous Training (MICT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 6MWT

    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

    Measured: 12 week

  2. Digital Spirometer

    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.

    Measured: 12 week

  3. VO₂ Peak

    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.

    Measured: 12 weeks

  4. IPAQ

    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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2026
  2. Study start10 Feb 2024
  3. Primary completion5 Jan 2025
  4. Study completion5 Jan 2025

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07438717
Sponsor's protocol ID
REC/RCR&AHS/24/0385
Status last verified
Feb 2026
First submitted
23 Feb 2026
Last updated
27 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 33663778
  • 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.

    PubMed 32130653
  • 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.

    PubMed 32975133
  • 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.

    PubMed 32138529
  • 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.

    PubMed 34793360
  • 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.

    PubMed 35899970
  • 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.

    PubMed 32125550

Questions about this trial

What is this clinical trial studying?

A study testing Moderate-Intensity Interval Training (MIIT) and Moderate-Intensity Continuous Training (MICT) in people with Mitral Valve Replacement, run by Riphah International University at 1 site in Pakistan.

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 7 inclusion and 5 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: finished, as of the sponsor's last update on 27 Feb 2026. 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

6MWT (time frame: 12 week). 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?

On the ClinicalTrials.gov record for NCT07438717, which also lists 7 linked publications.

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 27 Feb 2026.

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