NCT03275038

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. 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. 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. 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. 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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

August 31, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

September 7, 2017

Status Verified

March 1, 2017

Enrollment Period

2.9 years

First QC Date

August 30, 2017

Last Update Submit

September 5, 2017

Conditions

Keywords

NeuroimageTrainingAgingBrainCardiovascular risks

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 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

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

Behavioral: Aerobic exercise

Interventions

Behavioral: Tai-Chi exercise

Tai-Chi exercise group

Behavioral: Aerobic exercise

Aerobic exercise group

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Aquatic TherapyExercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pei-Fang Tang, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Fang Tang, PhD

CONTACT

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

Locations