Physical ActivityNCT05672940
Investigations of the Effects and Associated Neural Mechanisms of Different Exercise in People With Metabolic Syndrome
A study testing Aerobic plus resistance training and Stretching plus breathing training in people with Physical Activity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Activity
- What is being tested?
- Aerobic plus resistance training and Stretching plus breathing training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Aug 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Collage of Public Health
Taipei, Zhongzheng, 100
Pei-Fang Tang, PhD, 02-33668128, pftang@ntu.edu.tw
About this study
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
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.
Read the 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.
- Conditions
- Physical Activity
- Being tested
- Aerobic plus resistance training, Stretching plus breathing training
- Keywords
- Neuroimage, Training, Aging, Brain, Cardiovascular risks, Metabolic syndrome
- Medical subject headings
- Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic plus resistance trainingBehavioural
Aerobic plus resistance training
Stretching plus breathing trainingBehavioural
Stretching plus breathing training
| Study group | Role | What they receive |
|---|---|---|
| Aerobic plus resistance training group | Experimental | 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. Receives: Behavioral: Aerobic plus resistance training |
| Stretching plus breathing training group | Experimental | Receive three one-hour sessions of weekly supervised group training combining Tongtze Gymnastics (童子體操) and breathing exercises for 12 weeks. Receives: Behavioral: Stretching plus breathing training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of brain functional activation and structure imaging
Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain
Measured: at baseline, 12 weeks exercise intervention
Secondary outcomes (15)
Neuropsychological test-CANTAB
Cambridge Neuropsychological Test Automated Battery
Measured: at baseline, 12 weeks exercise intervention
Neuropsychological test-AD8
Ascertain Dementia-8
Measured: at baseline, 12 weeks exercise intervention
Neuropsychological test-MoCA
Montreal Cognitive Assessment-Taiwan version
Measured: at baseline, 12 weeks exercise intervention
Neuropsychological test-CDR
Clinical Dementia Rating
Measured: at baseline, 12 weeks exercise intervention
Neuropsychological test-CTT
Color Trail Test (in seconds)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Muscle strength
Bilateral grip strength and knee extensor strength (in kilograms)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Flexibility
Chair Sit and Reach Test, The upper extremity and lower extremity/trunk flexibility were measured with the Scratch Test (in centimeters)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
One-legged Standing (in seconds)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
Chair Rise Test (in seconds)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
Four Square Step Test (in seconds)
Measured: at baseline, 12 weeks exercise intervention
Physical test-Gait mat
Gait analysis
Measured: at baseline, 12 weeks exercise intervention
Physical test-Heart rate variability
Heart rate variability
Measured: at baseline, 12 weeks exercise intervention
Physical test-Cardiovascular fitness
Cardiovascular fitness: 6-minute Walk Test
Measured: at baseline, 12 weeks exercise intervention
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
Measured: at baseline, 12 weeks exercise intervention
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
Measured: at baseline, 12 weeks exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start12 Aug 2020
- Primary completion31 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672940
- Sponsor's protocol ID
- 201912239RINB
- Other IDs
- MOST 111-2314-B-002-163 -
- Status last verified
- Dec 2022
- First submitted
- 19 Dec 2022
- Last updated
- 5 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05672940
- Acronym / sponsor ID
- 201912239RINB
- Conditions
- Physical Activity
- Keywords
- Neuroimage, Training, Aging, Brain, Cardiovascular risks, Metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 12 Aug 2020 (actual)
- Primary completion
- 31 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic plus resistance training group | Experimental | Behavioral: Aerobic plus resistance trainingReceive 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. |
| Stretching plus breathing training group | Experimental | Behavioral: Stretching plus breathing trainingReceive three one-hour sessions of weekly supervised group training combining Tongtze Gymnastics (童子體操) and breathing exercises for 12 weeks. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic plus resistance trainingAerobic plus resistance training | Behavioural | Aerobic plus resistance training group |
| Stretching plus breathing trainingStretching plus breathing training | Behavioural | Stretching plus breathing training group |
Primary outcome
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
15 secondary outcomes
Neuropsychological test-CANTAB
Time frame: at baseline, 12 weeks exercise intervention
Neuropsychological test-AD8
Time frame: at baseline, 12 weeks exercise intervention
Neuropsychological test-MoCA
Time frame: at baseline, 12 weeks exercise intervention
Neuropsychological test-CDR
Time frame: at baseline, 12 weeks exercise intervention
Neuropsychological test-CTT
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Muscle strength
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Flexibility
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Balance and mobility
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Gait mat
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Heart rate variability
Time frame: at baseline, 12 weeks exercise intervention
Physical test-Cardiovascular fitness
Time frame: at baseline, 12 weeks exercise intervention
Cardiopulmonary test
Time frame: at baseline, 12 weeks exercise intervention
Number of participants with Abnormal Laboratory Values
Time frame: at baseline, 12 weeks exercise intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Fang Tang, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic plus resistance training and Stretching plus breathing training in people with Physical Activity, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Fang Tang, PhD (02-33668128, pftang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of brain functional activation and structure imaging (time frame: at baseline, 12 weeks exercise intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.