A Pilot Randomized Controlled Trial Comparing Core Exercise, Aerobic Exercise, and Combined Exercise in Patients Undergoing Phase II Cardiac Rehabilitation.

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 Overview

• Status: Recruiting
• Conditions: Heart Failure; Myocardial Infarction (MI); Clinically Stable Myocardial Infarction or Heart Failure Patients
• Intervention / Treatment: Other: Core exercise training; Other: conventional cardiac rehabilitation (aerobic training); Other: combined training

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hung-Jui Chuang, Dr.; Phone Number: +886972653162; Email: hjchuang@ntuh.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Hung-Jui Chunag, Dr.; Phone Number: +886972653162; Email: hjchuang@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core Exercise group; tow sessions core exercise training per week	Other: Core exercise training; 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.
Active Comparator: Aerobic exercise group; two sessions aerobic training per week	Other: 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.
Active Comparator: Combined exercise group; one session core exercise training and one session aerobic training per week	Other: combined training; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak oxygen uptake	The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).	Week 0 and after 8-week training program

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	At Week 0 and after 8-week training program

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Heart Failure; Myocardial Infarction
• Other Study ID Numbers: 202507175RINC

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