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

January 4, 2023 updated by: National Taiwan University Hospital

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

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.

Study Overview

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

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Zhongzheng
      • Taipei, Zhongzheng, Taiwan, 100
        • Recruiting
        • National Taiwan University Collage of Public Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
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
Cardiovascular fitness: 6-minute Walk Test
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pei-Fang Tang, PhD, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 12, 2020

Primary Completion (Anticipated)

July 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

January 4, 2023

First Posted (Actual)

January 5, 2023

Study Record Updates

Last Update Posted (Actual)

January 5, 2023

Last Update Submitted That Met QC Criteria

January 4, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Physical Activity

Clinical Trials on Aerobic plus resistance training

3
Subscribe