Back to resultsInvestigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome
Primary Purpose
Physical Activity
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic plus resistance training
Stretching plus breathing training
Sponsored by
About this trial
This is an interventional prevention trial for Physical Activity focused on measuring Neuroimage, Training, Aging, Brain, Cardiovascular risks, Metabolic syndrome
Eligibility Criteria
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.
Sites / Locations
- National Taiwan University Collage of Public HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Aerobic plus resistance training group
Stretching plus breathing training group
Arm Description
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.
Receive three one-hour sessions of weekly supervised group training combining Tongtze Gymnastics (童子體操) and breathing exercises for 12 weeks.
Outcomes
Primary Outcome Measures
Changes of brain functional activation and structure imaging
Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain
Secondary Outcome Measures
Neuropsychological test-CANTAB
Cambridge Neuropsychological Test Automated Battery
Neuropsychological test-AD8
Ascertain Dementia-8
Neuropsychological test-MoCA
Montreal Cognitive Assessment-Taiwan version
Neuropsychological test-CDR
Clinical Dementia Rating
Neuropsychological test-CTT
Color Trail Test (in seconds)
Physical test-Muscle strength
Bilateral grip strength and knee extensor strength (in kilograms)
Physical test-Flexibility
Chair Sit and Reach Test, The upper extremity and lower extremity/trunk flexibility were measured with the Scratch Test (in centimeters)
Physical test-Balance and mobility
One-legged Standing (in seconds)
Physical test-Balance and mobility
Chair Rise Test (in seconds)
Physical test-Balance and mobility
Four Square Step Test (in seconds)
Physical test-Gait mat
Gait analysis
Physical test-Heart rate variability
Heart rate variability
Physical test-Cardiovascular fitness
Cardiovascular fitness: 6-minute Walk Test
Cardiopulmonary test
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
Number of participants with Abnormal Laboratory Values
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
Full Information
NCT ID
NCT05672940
First Posted
December 19, 2022
Last Updated
January 4, 2023
Sponsor
National Taiwan University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05672940
Brief Title
Investigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 12, 2020 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Metabolic syndrome (MetS) is a risk for many chronic diseases of middle-aged and older adults. Hence, prevention and treatment of MetS is a crucial global health issue. However, it remains unclear regarding the cognitive effects and associated neural mechanisms of exercise interventions in this population. Therefore, the aims of this three-year project are to compare the effects and neural mechanism of three different types of exercise interventions, on components of MetS, as well as neuropsychological and physical functions in middle-aged and older adults with MetS.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity
Keywords
Neuroimage, Training, Aging, Brain, Cardiovascular risks, Metabolic syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic plus resistance training group
Arm Type
Experimental
Arm Description
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.
Arm Title
Stretching plus breathing training group
Arm Type
Experimental
Arm Description
Receive three one-hour sessions of weekly supervised group training combining Tongtze Gymnastics (童子體操) and breathing exercises for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Aerobic plus resistance training
Intervention Description
Aerobic plus resistance training
Intervention Type
Behavioral
Intervention Name(s)
Stretching plus breathing training
Intervention Description
Stretching plus breathing training
Primary Outcome Measure Information:
Title
Changes of brain functional activation and structure imaging
Description
Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain
Time Frame
at baseline, 12 weeks exercise intervention
Secondary Outcome Measure Information:
Title
Neuropsychological test-CANTAB
Description
Cambridge Neuropsychological Test Automated Battery
Time Frame
at baseline, 12 weeks exercise intervention
Title
Neuropsychological test-AD8
Description
Ascertain Dementia-8
Time Frame
at baseline, 12 weeks exercise intervention
Title
Neuropsychological test-MoCA
Description
Montreal Cognitive Assessment-Taiwan version
Time Frame
at baseline, 12 weeks exercise intervention
Title
Neuropsychological test-CDR
Description
Clinical Dementia Rating
Time Frame
at baseline, 12 weeks exercise intervention
Title
Neuropsychological test-CTT
Description
Color Trail Test (in seconds)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Muscle strength
Description
Bilateral grip strength and knee extensor strength (in kilograms)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Flexibility
Description
Chair Sit and Reach Test, The upper extremity and lower extremity/trunk flexibility were measured with the Scratch Test (in centimeters)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Balance and mobility
Description
One-legged Standing (in seconds)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Balance and mobility
Description
Chair Rise Test (in seconds)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Balance and mobility
Description
Four Square Step Test (in seconds)
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Gait mat
Description
Gait analysis
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Heart rate variability
Description
Heart rate variability
Time Frame
at baseline, 12 weeks exercise intervention
Title
Physical test-Cardiovascular fitness
Description
Cardiovascular fitness: 6-minute Walk Test
Time Frame
at baseline, 12 weeks exercise intervention
Title
Cardiopulmonary test
Description
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
Time Frame
at baseline, 12 weeks exercise intervention
Title
Number of participants with Abnormal Laboratory Values
Description
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
Time Frame
at baseline, 12 weeks exercise intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pei-Fang Tang, PhD
Phone
02-33668128
Email
pftang@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Fang Tang, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Collage of Public Health
City
Taipei
State/Province
Zhongzheng
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei-Fang Tang, PhD
Phone
02-33668128
Email
pftang@ntu.edu.tw
12. IPD Sharing Statement
Learn more about this trial
Investigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome
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