Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises (NCT03275038) | Clinical Trial Compass
UnknownNot Applicable
Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises
Taiwan120 participantsStarted 2017-08-31
Plain-language summary
In this three-year project, investigators will target on sedentary middle-aged and older adults with cardiovascular risks, prescribe 24-week Tai Chi or aerobic exercises and examine:
1. Whether both exercises are effective to reduce cardiovascular risks, prevent leukoaraiosis and associated declines in physical and psychological functions at Week 12 and 24;
2. Will Tai Chi exercises be more effective on improving psychological health (cognition, psychological well-being, and exercise self-efficacy) than aerobic exercises at Week 12 and 24? If yes, are these effects mediated by specific brain structural and functional mechanisms?
3. Will aerobic exercises be more effective on improving physical health (motor functions, physical fitness, and heart rate variability) than Tai Chi exercises at Week 12 and 24? If yes, are these effects mediated by other specific brain structural and functional mechanisms?
4. After 12 and 24 weeks of Tai Chi and aerobic exercises, what are the relationships between reduction of cardiovascular risks and changes in brain structure and functions?
An assessor-blind randomized controlled clinical trial will be used. Based on known effect size of Tai Chi exercises on cognitive function (please refer to CM03, pages 9-10), 120 sedentary middle-aged and older adults with cardiovascular risks will be recruited and randomly assigned to the Tai Chi, Aerobic, or Control (usual care) group. The Tai Chi and Aerobic groups will receive three one-hour exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks. The Control group will maintain the original life style. Clinical measures of cardiovascular risks and blood markers, brain structures and functional images, psychological (cognitive, psychological well-being and exercise self-efficacy) and physical (motor functions, physical fitness, and heart rate variability) functions will be collected at baseline, Week 12, and Week 24 to compare differences among the three groups across the three time points. Investigators will also examine the interrelationships of changes in brain structural and functional organization with changes in other measures, in an effort to understand the neural mechanisms of exercise effects.
Who can participate
Age range45 Years – 80 Years
SexALL
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Inclusion criteria
✓. Age between 45 and 80 years old
✓. Literacy
✓. With cardiovascular risks, defined as having hypertension (defined as resting systolic BP≧140 mmHg or resting diastolic BP≧90 mmHg, or receiving antihypertensive medication), diabetes mellitus (defined as taking oral antidiabetics or insulin or fasting plasma glucose being ≥100 mg/dL), dyslipidemia (defined as receiving lipid-lowering medication and diet therapy or total cholesterol \> 200 mg/dL or triglyceride \> 150 mg/dL (Lan et al., 2008)), or a combination of two or three of these risks
✓. Being physically inactive (defined as being engaged in physical activities for less than a total of 90 minutes per week) in recent one year
✓. Have no prior experiences with Tai Chi, yoga, chi gung, or other meditative forms of exercises
✓. No expectation of the need of changing medication in the following 8 months from the physicians
Exclusion criteria
✕. Having any contraindications for fMRI (e.g., claustrophobia and indwelling metals or implanted devices)