National Taiwan University Hospital
Taipei, Taiwan
Location status: Recruiting
NCT Number: NCT07243769
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Taipei, Taiwan
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Two aerobic training sessions per week, 1 hour per session. Aerobic program targets 40-80% heart-rate reserve on a treadmill or cycle ergometer.
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.
Time frame: Week 0 and after 8-week training program
The peak oxygen uptake (VO₂peak) is measured using a cardiopulmonary exercise testing (CPET).
Time frame: Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Time frame: At Week 0 and after 8-week training program
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.
Time frame: At Week 0 and after 8-week training program
Body fat percentage and lean body mass are measured using bioelectrical impedance analysis (BIA).
Contact information is provided by the study sponsor or research team.
National Taiwan University Hospital
Other
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