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

NCT07438717 | Completed

• 1 other identifier: REC/RCR&AHS/24/0385
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitral Valve Replacement

Keywords

Cardiac efficiency; continuous training; mitral valve replacement; moderate-intensity interval training; physical capacity; pulmonary function; quality of life

Outcome Measures

Primary Outcomes (4)

• 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

  12 week

• 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.

  12 week

• 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.

  12 weeks

• 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

  12 weeks

Study Arms (2)

Group A: Moderate-Intensity Interval Training (MIIT)

EXPERIMENTAL

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)

Group B: Moderate-Intensity Continuous Training (MICT)

EXPERIMENTAL

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)

Interventions

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.

Group A: Moderate-Intensity Interval Training (MIIT)

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.

Group B: Moderate-Intensity Continuous Training (MICT)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

PIC Hospital, Lahore.

Lahore, Punjab Province, 42000, Pakistan

Location

Related Publications (7)

• 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.

  PMID: 33663778 BACKGROUND

• 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.

  PMID: 32130653 BACKGROUND

• 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.

  PMID: 32975133 BACKGROUND

• 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.

  PMID: 32138529 BACKGROUND

• 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.

  PMID: 34793360 BACKGROUND

• 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.

  PMID: 35899970 BACKGROUND

• 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.

  PMID: 32125550 BACKGROUND

Study Officials

• Hafiza Muriam Ghani, MS-CPPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: February 10, 2024
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)