Investigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05672940

Collaborator

(none)

120

Enrollment

Location

Arms

40.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity	Behavioral: Aerobic plus resistance training Behavioral: Stretching plus breathing training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Aug 12, 2020

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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.	Behavioral: Aerobic plus resistance training 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.	Behavioral: Stretching plus breathing training Stretching plus breathing training

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.

Behavioral: Aerobic plus resistance training

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.

Behavioral: Stretching plus breathing training

Stretching plus breathing training

Outcome Measures

Primary Outcome Measures

Changes of brain functional activation and structure imaging [at baseline, 12 weeks exercise intervention]
Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain

Secondary Outcome Measures

Neuropsychological test-CANTAB [at baseline, 12 weeks exercise intervention]
Cambridge Neuropsychological Test Automated Battery
Neuropsychological test-AD8 [at baseline, 12 weeks exercise intervention]
Ascertain Dementia-8
Neuropsychological test-MoCA [at baseline, 12 weeks exercise intervention]
Montreal Cognitive Assessment-Taiwan version
Neuropsychological test-CDR [at baseline, 12 weeks exercise intervention]
Clinical Dementia Rating
Neuropsychological test-CTT [at baseline, 12 weeks exercise intervention]
Color Trail Test (in seconds)
Physical test-Muscle strength [at baseline, 12 weeks exercise intervention]
Bilateral grip strength and knee extensor strength (in kilograms)
Physical test-Flexibility [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)
Physical test-Balance and mobility [at baseline, 12 weeks exercise intervention]
One-legged Standing (in seconds)
Physical test-Balance and mobility [at baseline, 12 weeks exercise intervention]
Chair Rise Test (in seconds)
Physical test-Balance and mobility [at baseline, 12 weeks exercise intervention]
Four Square Step Test (in seconds)
Physical test-Gait mat [at baseline, 12 weeks exercise intervention]
Gait analysis
Physical test-Heart rate variability [at baseline, 12 weeks exercise intervention]
Heart rate variability
Physical test-Cardiovascular fitness [at baseline, 12 weeks exercise intervention]
Cardiovascular fitness: 6-minute Walk Test
Cardiopulmonary test [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
Number of participants with Abnormal Laboratory Values [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.