Clinically Stable Myocardial Infarction or Heart Failure PatientsNCT07243769
A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.
A study testing Core exercise training, conventional cardiac rehabilitation (aerobic training) and combined training in people with Clinically Stable Myocardial Infarction or Heart Failure Patients and Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cardiac rehabilitation (CR) is recommended after myocardial infarction (MI) or heart failure (HF), yet the added value of core muscle endurance training within CR remains uncertain. This randomized, three-arm trial will enroll 60 adults with stable MI or HF who are referred to Phase II CR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Stable Myocardial Infarction or Heart Failure Patients, Heart Failure, Myocardial Infarction (MI)
- What is being tested?
- Core exercise training, conventional cardiac rehabilitation (aerobic training) and combined training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years.
- Diagnosed with myocardial infarction or heart failure with stable condition, and referred for participation in Phase II cardiac rehabilitation.
- Able to regularly attend training sessions twice a week.
Who cannot join
- Underwent cardiac surgery within the past three months.
- Presence of a pacemaker, defibrillator, or left ventricular assist device.
- Cognitive impairment or dementia that prevents understanding or following training instructions.
- Inability to complete cardiopulmonary exercise testing.
- Pregnancy.
- Contraindications to cardiac rehabilitation based on the American College of Sports Medicine (ACSM) guidelines, such as unstable angina, uncontrolled severe hypertension (resting systolic BP >180 mmHg or diastolic BP >110 mmHg), orthostatic hypotension (drop in BP >20 mmHg upon position change), severe aortic stenosis, uncontrolled severe arrhythmia, decompensated heart failure, third-degree atrioventricular block, acute pericarditis or myocarditis, aortic dissection, acute pulmonary embolism, or other acute medical conditions such as infection or fever.
- Refusal to participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Hung-Jui Chunag, Dr., +886972653162, hjchuang@ntuh.gov.tw
About this study
Cardiac rehabilitation (CR) is recommended after myocardial infarction (MI) or heart failure (HF), yet the added value of core muscle endurance training within CR remains uncertain. This randomized, three-arm trial will enroll 60 adults with stable MI or HF who are referred to Phase II CR. After consent and baseline testing, participants are allocated 1:1:1 to: (1) Pilates-based core endurance training, (2) standard aerobic CR (treadmill or cycle), or (3) combined aerobic plus core training. Supervised sessions occur twice weekly for eight weeks (~60 minutes/session) with continuous safety monitoring. The primary aim is to evaluate feasibility and safety of core training in this population. The study also compares effects of the three programs on cardiorespiratory fitness and function (e.g., peak oxygen uptake, six-minute walk distance), core endurance, balance, symptoms, and health-related quality of life. Findings will clarify whether adding core training improves outcomes and inform clinical exercise prescription in CR.
- Conditions
- Clinically Stable Myocardial Infarction or Heart Failure Patients, Heart Failure, Myocardial Infarction (MI)
- Being tested
- Core exercise training, conventional cardiac rehabilitation (aerobic training), combined training
- Medical subject headings
- Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core exercise trainingOther
Two core sessions per week, 1 hour per session. Pilates-based core endurance training progressing in difficulty with emphasis on breathing and posture; exercises performed in sitting, supine, prone, and quadruped positions.
conventional cardiac rehabilitation (aerobic training)Other
Two aerobic training sessions per week, 1 hour per session. Aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.
combined trainingOther
One core training session and one aerobic training session per week, 1hr per session. Core program (Pilates-based) progresses in difficulty with emphasis on breathing and posture; aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.
| Study group | Role | What they receive |
|---|---|---|
| Core Exercise group | Experimental | tow sessions core exercise training per week Receives: Other: Core exercise training |
| Aerobic exercise group | Active comparator | two sessions aerobic training per week Receives: Other: conventional cardiac rehabilitation (aerobic training) |
| Combined exercise group | Active comparator | one session core exercise training and one session aerobic training per week Receives: Other: combined training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).
Measured: Week 0 and after 8-week training program
Secondary outcomes (10)
Six-minute walk distance
Participants are instructed to walk back and forth as quickly as possible along a flat, hard-surfaced indoor corridor for six minutes. The total distance walked within six minutes is recorded.
Measured: Week 0 and after 8-week training program
One-leg stand test
Participants stand barefoot on one leg, keeping the opposite leg lifted without touching the supporting leg. Hands are placed on the hips, and eyes are open, gazing forward. The maximum duration of stable standing is recorded. Each leg is tested twice, and the best score is used for analysis.
Measured: At Week 0 and after 8-week training program
Plank endurance
Participants assume a forearm plank position, maintaining a straight trunk with core engaged. The duration for which the position is held is recorded. The body must remain in a straight line from head to heels, with no sagging of the hips.
Measured: At Week 0 and after 8-week training program
Side plank endurance
Participants perform side planks on the left and right sides, supporting the body with one forearm while keeping the body in a straight line. The holding time for each side is recorded separately.
Measured: At Week 0 and after 8-week training program
Trunk flexor endurance test
Performed using McGill's trunk flexor endurance protocol. Participants sit on a 60-degree inclined board with hips and knees bent at 90 degrees and arms crossed over the chest. The support board is then removed, and participants are asked to maintain the trunk at a 60-degree angle from the ground for as long as possible. The test ends when the participant can no longer hold the position.
Measured: At Week 0 and after 8-week training program
Lumbo-pelvic control test
Participants lie supine in a crook-lying position (knees bent) with a pressure biofeedback unit placed under the third lumbar vertebra, inflated to 40 mmHg. Participants are instructed to slowly lift both legs to 90° hip flexion. If the pressure change is less than 10 mmHg during lifting, it is considered a success, indicating stable lumbar control; a change greater than 10 mmHg indicates failure due to uncontrolled lumbar flexion. Participants then lower both legs from 90° to 45° hip flexion. If the pressure change is less than 10 mmHg, it is considered a success, indicating good lumbar stability; a change greater than 10 mmHg indicates failure due to uncontrolled lumbar extension.
Measured: At Week 0 and after 8-week training program
30 seconds sit to stand test
Participants sit on an armless chair with arms crossed over the chest and are instructed to stand up and sit down as many times as possible within 30 seconds. The total number of full sit-to-stand repetitions is recorded.
Measured: From enrollment to the end of treatment at 8 weeks
Hand grip strength
Participants sit with the dominant arm relaxed at the side, elbow flexed at 90°, and hold a hand dynamometer. They are instructed to squeeze maximally for 2-3 seconds. Three trials are performed with 30-second rest intervals, and the highest value is recorded as the maximal handgrip strength.
Measured: From enrollment to the end of treatment at 8 weeks
Time to exhaustion at 80% of VO₂peak
Based on the results of the baseline cardiopulmonary exercise test, participants perform a constant-load exercise at 80% of their VO₂peak until volitional exhaustion or until reaching test termination criteria. The total exercise time to exhaustion is recorded.
Measured: At Week 0 and after 8-week training program
Body composition
Body fat percentage and lean body mass are measured using bioelectrical impedance analysis (BIA).
Measured: At Week 0 and after 8-week training program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Stable Myocardial Infarction or Heart Failure PatientsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243769
- Sponsor's protocol ID
- 202507175RINC
- Status last verified
- Oct 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.
- ClinicalTrials.gov ID
- NCT07243769
- Acronym / sponsor ID
- 202507175RINC
- Conditions
- Clinically Stable Myocardial Infarction or Heart Failure Patients, Heart Failure, Myocardial Infarction (MI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiac rehabilitation (CR) is recommended after myocardial infarction (MI) or heart failure (HF), yet the added value of core muscle endurance training within CR remains uncertain. This randomized, three-arm trial will enroll 60 adults with stable MI or HF who are referred to Phase II CR. After consent and baseline testing, participants are allocated 1:1:1 to: (1) Pilates-based core endurance training, (2) standard aerobic CR (treadmill or cycle), or (3) combined aerobic plus core training. Supervised sessions occur twice weekly for eight weeks (~60 minutes/session) with continuous safety monitoring. The primary aim is to evaluate feasibility and safety of core training in this population. The study also compares effects of the three programs on cardiorespiratory fitness and function (e.g., peak oxygen uptake, six-minute walk distance), core endurance, balance, symptoms, and health-related quality of life. Findings will clarify whether adding core training improves outcomes and inform clinical exercise prescription in CR.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Core Exercise group | Experimental | Other: Core exercise trainingtow sessions core exercise training per week |
| Aerobic exercise group | Active comparator | Other: conventional cardiac rehabilitation (aerobic training)two sessions aerobic training per week |
| Combined exercise group | Active comparator | Other: combined trainingone session core exercise training and one session aerobic training per week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18 years.
- Diagnosed with myocardial infarction or heart failure with stable condition, and referred for participation in Phase II cardiac rehabilitation.
- Able to regularly attend training sessions twice a week.
Key exclusion criteria (7 listed)
- Underwent cardiac surgery within the past three months.
- Presence of a pacemaker, defibrillator, or left ventricular assist device.
- Cognitive impairment or dementia that prevents understanding or following training instructions.
- Inability to complete cardiopulmonary exercise testing.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core exercise trainingTwo core sessions per week, 1 hour per session. Pilates-based core endurance training progressing in difficulty with emphasis on breathing and posture; exercises performed in sitting, supine, prone, and quadruped positions. | Other | Core Exercise group |
| conventional cardiac rehabilitation (aerobic training)Two aerobic training sessions per week, 1 hour per session. Aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer. | Other | Aerobic exercise group |
| combined trainingOne core training session and one aerobic training session per week, 1hr per session. Core program (Pilates-based) progresses in difficulty with emphasis on breathing and posture; aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer. | Other | Combined exercise group |
Primary outcome
Peak oxygen uptake
Time frame: Week 0 and after 8-week training program
The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).
10 secondary outcomes
Six-minute walk distance
Time frame: Week 0 and after 8-week training program
One-leg stand test
Time frame: At Week 0 and after 8-week training program
Plank endurance
Time frame: At Week 0 and after 8-week training program
Side plank endurance
Time frame: At Week 0 and after 8-week training program
Trunk flexor endurance test
Time frame: At Week 0 and after 8-week training program
Lumbo-pelvic control test
Time frame: At Week 0 and after 8-week training program
30 seconds sit to stand test
Time frame: From enrollment to the end of treatment at 8 weeks
Hand grip strength
Time frame: From enrollment to the end of treatment at 8 weeks
Time to exhaustion at 80% of VO₂peak
Time frame: At Week 0 and after 8-week training program
Body composition
Time frame: At Week 0 and after 8-week training program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core exercise training, conventional cardiac rehabilitation (aerobic training) and combined training in people with Clinically Stable Myocardial Infarction or Heart Failure Patients and Heart Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 24 Nov 2025. 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hung-Jui Chuang, Dr. (+886972653162, hjchuang@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen uptake (time frame: Week 0 and after 8-week training program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Nov 2025.