- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05672940
Investigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome
Investigations of the Effects and Associated Neural Mechanisms of Different Long-term Exercise Interventions on Improving Brain, Cognitive, and Physical Functions in Middle-aged and Older Adults With Metabolic Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This three-year study is an assessor-blind randomized controlled clinical trial. Another 67 middle-aged and older adults with MetS without regular exercise habits will be recruited and randomly assigned into the combined aerobic and resistance training (AT/RT) or Control (stretching and breathing exercise, ST/BR) group. All participants will undertake three one-hour sessions of exercises for 12 weeks, being supervised . Participants will also wear a wearable device that monitors, records, and provides feedback about their physical activity levels and heart rates during the entire 12 weeks. The outcome measures include participants's components of MetS and performance on neuropsychological and physical tests and structural and functional brain imaging parameters collected at pre-training, and post-training (week 12) tests. The investigators will compare the differences on all of these outcome measures and analyze the relationships between changes in brain structure and functional activation in relationship with other outcome measures in order to understand the neural mechanisms of the training effects and the differences in these mechanisms between the two groups.
Results of this study will provide important scientific evidence and clinical decision bases for determining effective exercise interventions in preventing the progression of MetS, improving neuropsychological and physical functions of MetS, as well as elucidating the neural mechanisms underlying these improvements.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Pei-Fang Tang, PhD
- Phone Number: 02-33668128
- Email: pftang@ntu.edu.tw
Study Locations
-
-
Zhongzheng
-
Taipei, Zhongzheng, Taiwan, 100
- Recruiting
- National Taiwan University Collage of Public Health
-
Contact:
- Pei-Fang Tang, PhD
- Phone Number: 02-33668128
- Email: pftang@ntu.edu.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 45 and 80 years old
- Literacy
- Diagnosed with MetS based on the International Diabetes Federation (IDF) definition (Alberti et al., 2006) The IDF definition of MetS includes central obesity, determined by waist circumference at the midpoint between the lowest rib and iliac crest being ≧ 90 cm for men and ≧ 80 cm for women, plus at least two of the following conditions- (a) TG ≧ 150 mg/dl or being treated for this lipid abnormality, (b) HDL-C < 40 mg/dl in men, < 50 mg/dl in women, or being treated for this lipid abnormality, (c) systolic blood pressure (SBP) ≧ 130 mmHg, or systolic blood pressure (DBP) ≧ 85 mmHg, or being treated for diagnosed hypertension, and (d) FPG ≧ 100 mg/dl or diagnosed Type II DM).
- Living with a sedentary lifestyle (defined as being engaged in physical activities for less than a total of 90 minutes per week) (Fletcher et al., 1996) in recent one year.
Exclusion Criteria:
- Having any contraindications for fMRI (e.g., claustrophobia and indwelling metals or implanted devices)
- Serious or uncontrolled cardiovascular or pulmonary conditions (e.g., unstable angina, serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic or carotid stenosis, pulmonary embolus or infarction, resting SBP ≥ 180 mmHg, or resting DBP ≥ 110 mmHg)
- Severe renal failure (Stages 4 and 5 of chronic kidney diseases (Levin et al., 2013)
- Symptoms or histories of neurological diseases, including transient ischemic attack
- Severe musculoskeletal disorders which would affect their mobility
- Diagnosis of dementia, Montreal Cognitive Assessment (MoCA) (Taiwan version) < 22 (Tsai et al., 2012; Wang et al., 2013), or inability to follow instructions
- Psychiatric disorders (including depression) or Geriatric Depression Scale-short form (GDS-15) score≧8 (Sheikh & Yesavage, 1986)
- Having contraindications for doing exercises (e.g., resting SBP ≥ 180 mmHg, resting DBP ≥ 110 mmHg, FPG ≥ 300 mg/dL, hypoglycemia (plasma glucose ≤ 70 mg/dL) after exercises, or postural hypotension (BP drop ≥ 20 mmHg when changing postures)
- Life expectancy less than six months due to any disease.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Aerobic plus resistance training group
Receive three one-hour supervised group sessions weekly for 12 weeks, in which Sections 1 and 3 were AT plus RT sessions, including 5-minute warm-up, 30-minute AT exercises on a bicycle (Comfort 408, Horizon Fitness) or a treadmill (832T, Horizon Fitness), 20-minute RT, and 5-minute cool-down; whereas Section 2 was an AT-only session, including 5-minute warm up, 50-minute aerobic exercises (bicycling or treadmill walking), and 5-minute cool-down.
|
Aerobic plus resistance training
|
Experimental: Stretching plus breathing training group
Receive three one-hour sessions of weekly supervised group training combining Tongtze Gymnastics (童子體操) and breathing exercises for 12 weeks.
|
Stretching plus breathing training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of brain functional activation and structure imaging
Time Frame: at baseline, 12 weeks exercise intervention
|
Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain
|
at baseline, 12 weeks exercise intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropsychological test-CANTAB
Time Frame: at baseline, 12 weeks exercise intervention
|
Cambridge Neuropsychological Test Automated Battery
|
at baseline, 12 weeks exercise intervention
|
Neuropsychological test-AD8
Time Frame: at baseline, 12 weeks exercise intervention
|
Ascertain Dementia-8
|
at baseline, 12 weeks exercise intervention
|
Neuropsychological test-MoCA
Time Frame: at baseline, 12 weeks exercise intervention
|
Montreal Cognitive Assessment-Taiwan version
|
at baseline, 12 weeks exercise intervention
|
Neuropsychological test-CDR
Time Frame: at baseline, 12 weeks exercise intervention
|
Clinical Dementia Rating
|
at baseline, 12 weeks exercise intervention
|
Neuropsychological test-CTT
Time Frame: at baseline, 12 weeks exercise intervention
|
Color Trail Test (in seconds)
|
at baseline, 12 weeks exercise intervention
|
Physical test-Muscle strength
Time Frame: at baseline, 12 weeks exercise intervention
|
Bilateral grip strength and knee extensor strength (in kilograms)
|
at baseline, 12 weeks exercise intervention
|
Physical test-Flexibility
Time Frame: at baseline, 12 weeks exercise intervention
|
Chair Sit and Reach Test, The upper extremity and lower extremity/trunk flexibility were measured with the Scratch Test (in centimeters)
|
at baseline, 12 weeks exercise intervention
|
Physical test-Balance and mobility
Time Frame: at baseline, 12 weeks exercise intervention
|
One-legged Standing (in seconds)
|
at baseline, 12 weeks exercise intervention
|
Physical test-Balance and mobility
Time Frame: at baseline, 12 weeks exercise intervention
|
Chair Rise Test (in seconds)
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at baseline, 12 weeks exercise intervention
|
Physical test-Balance and mobility
Time Frame: at baseline, 12 weeks exercise intervention
|
Four Square Step Test (in seconds)
|
at baseline, 12 weeks exercise intervention
|
Physical test-Gait mat
Time Frame: at baseline, 12 weeks exercise intervention
|
Gait analysis
|
at baseline, 12 weeks exercise intervention
|
Physical test-Heart rate variability
Time Frame: at baseline, 12 weeks exercise intervention
|
Heart rate variability
|
at baseline, 12 weeks exercise intervention
|
Physical test-Cardiovascular fitness
Time Frame: at baseline, 12 weeks exercise intervention
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Cardiovascular fitness: 6-minute Walk Test
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at baseline, 12 weeks exercise intervention
|
Cardiopulmonary test
Time Frame: at baseline, 12 weeks exercise intervention
|
Cycling on the cycle ergometer: Indicate participant's submaximal and maximal cardiovascular fitness level, respectively, and served as references when setting participant's target heart rate for exercise training
|
at baseline, 12 weeks exercise intervention
|
Number of participants with Abnormal Laboratory Values
Time Frame: at baseline, 12 weeks exercise intervention
|
The following MetS and cardiovascular risk related biomarkers: total cholesterol, triglyceride, HDL, LDL, Fasting plasma glucose, fasting plasma insulin, HbA1c, serum adiponectin level, serum leptin level, and homocysteine
|
at baseline, 12 weeks exercise intervention
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pei-Fang Tang, PhD, National Taiwan University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201912239RINB
- MOST 111-2314-B-002-163 - (Other Grant/Funding Number: Ministry of Science and Technology, Taiwan)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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