Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises
1 other identifier
interventional
120
1 country
1
Brief 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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedFirst Posted
Study publicly available on registry
September 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedSeptember 7, 2017
March 1, 2017
2.9 years
August 30, 2017
September 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain functional activation and structure imaging
fMRI activation patterns and white and gray matter changes of the brain
up to 6 months
Secondary Outcomes (4)
Physical Activity Scale for the Elderly
up to 6 months
Geriatric Depression Scale short-form
up to 6 months
Mindfulness Attention Awareness Scale
up to 6 months
The AD8 scale
baseline
Study Arms (3)
Control group
NO INTERVENTIONMaintain the original life style
Tai-Chi exercise group
EXPERIMENTALReceive three one-hour Tai Chi exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks
Aerobic exercise group
EXPERIMENTALReceive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Having any contraindications for fMRI (e.g., claustrophobia and indwelling metals or implanted devices)
- Serious or uncontrolled cardiac or metabolic conditions (e.g., unstable angina, serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic or carotid stenosis, pulmonary embolus or infarction, resting systolic BP ≥ 180 mmHg, resting diastolic BP ≥ 110 mmHg, fasting plasma glucose ≥ 300 mg/dL)
- Severe renal failure
- Symptoms or history of neurological diseases, including transient ischemic attack
- Severe musculoskeletal disorders which would affect their mobility
- Dementia or inability to follow instructions
- Psychiatric disorder
- Having contraindications for doing exercises (e.g., resting systolic BP ≥ 180 mmHg, resting diastolic BP ≥ 110 mmHg, fasting plasma glucose ≥ 300 mg/dL, hypoglycemia (plasma glucose ≤ 70 mg/dL) after exercises, and postural hypotension (BP drop ≥ 20 mmHg when changing postures)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Collage of Public Health
Taipei, Zhongzheng, 100, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pei-Fang Tang, PhD
National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2017
First Posted
September 7, 2017
Study Start
August 31, 2017
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
September 7, 2017
Record last verified: 2017-03