Physical ActivityNCT03275038
Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises
A study testing Tai-Chi exercise and Aerobic exercise in people with Physical Activity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Tai-Chi exercise and Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 31 Aug 2017to 31 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Collage of Public Health
Taipei, Zhongzheng, 100
Pei-Fang Tang, PhD, 02-33668128, pftang@ntu.edu.tw
About this study
Official title: Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity on the Prevention of Leukoaraiosis and Declines in Brain, Physical, and Psychological Functions in Middle-aged and Older Adults With Cardiovascular Risks
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:
- Whether both exercises are effective to reduce cardiovascular risks, prevent leukoaraiosis and associated declines in physical and psychological functions at Week 12 and 24;
- 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?
- 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?
- 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.
Read the detailed description
Leukoaraiosis prevails in middle-aged and older adults with cardiovascular risks. People with more severe leukoaraiosis would have greater risks for stroke, dementia, and disability. Tai Chi and aerobic exercises both can reduce cardiovascular risks; however, it remains unknown whether these two types of exercises also could prevent leukoaraiosis and associated declines in physical and psychological functions. In particular, would Tai Chi, a form of mind-body exercise, be more effective than aerobic exercises on improving psychological health with specific underlying brain structural and functional mechanisms? Would aerobic exercise be more effective than Tai Chi on improving physical healthy with different underlying brain structural and functional mechanisms?
Therefore, 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:
- Whether both exercises are effective to reduce cardiovascular risks, prevent leukoaraiosis and associated declines in physical and psychological functions at Week 12 and 24;
- 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?
- 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?
- 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 investigate 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.
Results of this study will not only provide scientific evidence basis for clinical decision-making of using exercise approaches to prevent the development of leukoaraiosis and its negative health impact in middle-aged and older adults with cardiovascular risks, but also reveal the underlying neural mechanisms.
- Conditions
- Physical Activity
- Being tested
- Tai-Chi exercise, Aerobic exercise
- Keywords
- Neuroimage, Training, Aging, Brain, Cardiovascular risks
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai-Chi exerciseBehavioural
Behavioral: Tai-Chi exercise
Aerobic exerciseBehavioural
Behavioral: Aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Maintain the original life style |
| Tai-Chi exercise group | Experimental | Receive three one-hour Tai Chi exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks Receives: Behavioral: Tai-Chi exercise |
| Aerobic exercise group | Experimental | Receive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain functional activation and structure imaging
fMRI activation patterns and white and gray matter changes of the brain
Measured: up to 6 months
Secondary outcomes (4)
Physical Activity Scale for the Elderly
assess daily physical activity
Measured: up to 6 months
Geriatric Depression Scale short-form
assess emotional status
Measured: up to 6 months
Mindfulness Attention Awareness Scale
assess mindfulness and attention
Measured: up to 6 months
The AD8 scale
A brief informant interview to detect dementia
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start31 Aug 2017
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275038
- Sponsor's protocol ID
- 201612213RINB
- Status last verified
- Mar 2017
- First submitted
- 30 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity on the Prevention of Leukoaraiosis and Declines in Brain, Physical, and Psychological Functions in Middle-aged and Older Adults With Cardiovascular Risks
- ClinicalTrials.gov ID
- NCT03275038
- Acronym / sponsor ID
- 201612213RINB
- Conditions
- Physical Activity
- Keywords
- Neuroimage, Training, Aging, Brain, Cardiovascular risks
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 7 Sep 2017 (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.
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:
- Whether both exercises are effective to reduce cardiovascular risks, prevent leukoaraiosis and associated declines in physical and psychological functions at Week 12 and 24;
- 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?
- 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?
- 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.
Detailed description
Leukoaraiosis prevails in middle-aged and older adults with cardiovascular risks. People with more severe leukoaraiosis would have greater risks for stroke, dementia, and disability. Tai Chi and aerobic exercises both can reduce cardiovascular risks; however, it remains unknown whether these two types of exercises also could prevent leukoaraiosis and associated declines in physical and psychological functions. In particular, would Tai Chi, a form of mind-body exercise, be more effective than aerobic exercises on improving psychological health with specific underlying brain structural and functional mechanisms? Would aerobic exercise be more effective than Tai Chi on improving physical healthy with different underlying brain structural and functional mechanisms?
Therefore, 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:
- Whether both exercises are effective to reduce cardiovascular risks, prevent leukoaraiosis and associated declines in physical and psychological functions at Week 12 and 24;
- 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?
- 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?
- 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 investigate 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.
Results of this study will not only provide scientific evidence basis for clinical decision-making of using exercise approaches to prevent the development of leukoaraiosis and its negative health impact in middle-aged and older adults with cardiovascular risks, but also reveal the underlying neural mechanisms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Maintain the original life style |
| Tai-Chi exercise group | Experimental | Behavioral: Tai-Chi exerciseReceive 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 | Experimental | Behavioral: Aerobic exerciseReceive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Tai-Chi exerciseBehavioral: Tai-Chi exercise | Behavioural | Tai-Chi exercise group |
| Aerobic exerciseBehavioral: Aerobic exercise | Behavioural | Aerobic exercise group |
Primary outcome
Brain functional activation and structure imaging
Time frame: up to 6 months
fMRI activation patterns and white and gray matter changes of the brain
4 secondary outcomes
Physical Activity Scale for the Elderly
Time frame: up to 6 months
Geriatric Depression Scale short-form
Time frame: up to 6 months
Mindfulness Attention Awareness Scale
Time frame: up to 6 months
The AD8 scale
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
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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. This study is not recruiting at the moment.
Pei-Fang Tang, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai-Chi exercise and Aerobic exercise in people with Physical Activity, 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 6 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 7 Sep 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Fang Tang, PhD (02-33668128, pftang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain functional activation and structure imaging (time frame: up to 6 months). 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 7 Sep 2017.