ClinicalTrials.gg
Status unknownNCT03275038Updated Sep 7, 2017

Comparing Effects and Neural Mechanisms of Tai Chi and Light-to-Moderate Intensity Aerobic Exercises

An interventional study of Tai-Chi exercise and Aerobic exercise in Physical Activity, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-07.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies in Motor Activity by National Taiwan University Hospital — 6 open to participants now, 7 under way, none of them phase 3. Motor Activity · National Taiwan University Hospital.

Planned enrollment
9th of 28
120 · median 106
Started
2017
the only one that year
No phase
28 of 33
4 open now
Registered
20th of 33
by date

Among the 33 studies in Motor Activity by National Taiwan University Hospital, this one is the 9th largest by planned enrollment of the 28 interventional ones that give a count, is the only one that started in 2017, is one of 28 with no phase, and was the 20th registered.

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

Browse Motor Activity studies →

Open to participants now

6 of the 33 studies in Motor Activity by National Taiwan University Hospital are open now, in 1 country. Recruiting first, the newest first:

1 more — sign in →

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.

This study: 45 Years to 80 Years · all sexes · healthy volunteers too.

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02

Study 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.

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:

  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 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.

03

Conditions studied

  • Physical Activity

Browse trials for

Keywords

  • Neuroimage
  • Training
  • Aging
  • Brain
  • Cardiovascular risks
04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between 45 and 80 years old
  2. Literacy
  3. 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
  4. Being physically inactive (defined as being engaged in physical activities for less than a total of 90 minutes per week) in recent one year
  5. Have no prior experiences with Tai Chi, yoga, chi gung, or other meditative forms of exercises
  6. No expectation of the need of changing medication in the following 8 months from the physicians

Exclusion criteria

Exclusion Criteria:

  1. Having any for fMRI (e.g., claustrophobia and indwelling metals or implanted devices)
  2. 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)
  3. Severe renal failure
  4. Symptoms or history of neurological diseases, including
  5. Severe musculoskeletal disorders which would affect their mobility
  6. Dementia or inability to follow instructions
  7. Psychiatric disorder
  8. 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
120 participants (estimated)

Study arms

  • No intervention
    Control group

    Maintain the original life style

  • Experimental
    Tai-Chi exercise group

    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

    Behavioral: Tai-Chi exercise

  • Experimental
    Aerobic exercise group

    Receive three one-hour aerobic exercise sessions weekly for 24 weeks, supervised for the first 12 weeks and unsupervised for the next 12 weeks

    Behavioral: Aerobic exercise

Interventions

  • BehavioralTai-Chi exercise

    Behavioral: Tai-Chi exercise

  • BehavioralAerobic exercise

    Behavioral: Aerobic exercise

06

What researchers measure

Primary outcomes

  1. Brain functional activation and structure imaging

    fMRI activation patterns and white and gray matter changes of the brain

    Time frame: up to 6 months

Secondary outcomes

  1. Physical Activity Scale for the Elderly

    assess daily physical activity

    Time frame: up to 6 months

  2. Geriatric Depression Scale short-form

    assess emotional status

    Time frame: up to 6 months

  3. Mindfulness Attention Awareness Scale

    assess mindfulness and attention

    Time frame: up to 6 months

  4. The AD8 scale

    A brief informant interview to detect dementia

    Time frame: baseline

07

Study locations

1 of 1 sites recruiting
  • National Taiwan University Collage of Public Health
    Taipei, Zhongzheng 100, Taiwan
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2017 (actual). Primary completion is estimated for Jul 2020, 35 months after the start.

Of 5,147 non-industry interventional studies with no phase under Motor Activity, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 36. This study's planned 35 months is above that.

Counting every sponsor, half of 5,207 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 30, 2017
First posted
Sep 7, 2017
StartActual
Aug 31, 2017
Primary completionEst.
Jul 31, 2020
CompletionEst.
Jul 31, 2020
Last update
Sep 7, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03275038
Responsible party
Sponsor
First posted
Sep 7, 2017
Start date
Aug 31, 2017
Primary completion
Jul 31, 2020 (estimated)
Completion
Jul 31, 2020 (estimated)
Last update
Sep 7, 2017

Study contacts

Pei-Fang Tang, PhD
Contact
pftang@ntu.edu.tw
02-33668128
Pei-Fang Tang, PhD
principal investigator · National Taiwan University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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