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

NCT05672940 | Unknown

• 2 other identifiers: 201912239RINBMOST 111-2314-B-002-163 -
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Physical Activity

Keywords

Neuroimage; Training; Aging; Brain; Cardiovascular risks; Metabolic syndrome

Outcome Measures

Primary Outcomes (1)

• Changes of brain functional activation and structure imaging

  Functional Magnetic Resonance Imaging (fMRI) activation patterns and white and gray matter changes of the brain

  at baseline, 12 weeks exercise intervention

Secondary Outcomes (15)

• Neuropsychological test-CANTAB

  at baseline, 12 weeks exercise intervention

• Neuropsychological test-AD8

  at baseline, 12 weeks exercise intervention

• Neuropsychological test-MoCA

  at baseline, 12 weeks exercise intervention

• Neuropsychological test-CDR

  at baseline, 12 weeks exercise intervention

• Neuropsychological test-CTT

  at baseline, 12 weeks exercise intervention

Study Arms (2)

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.

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.

Behavioral: Stretching plus breathing training

Interventions

Aerobic plus resistance training BEHAVIORAL

Aerobic plus resistance training

Aerobic plus resistance training group

Stretching plus breathing training BEHAVIORAL

Stretching plus breathing training

Stretching plus breathing training group

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Collage of Public Health

Taipei, Zhongzheng, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Motor Activity; Metabolic Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pei-Fang Tang, PhD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Fang Tang, PhD

CONTACT

02-33668128; pftang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 5, 2023
• Study Start: August 12, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 5, 2023

Record last verified: 2022-12

Locations

TW (1)