Effect of Aging & Obesity With Exercise Intervention

March 10, 2020 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

Biphasic and Combined Effect of Aging & Obesity With Development of Effective Exercise Intervention Protocol

Obesity leads to a vicious circle that increases intramuscular fat, insulin resistance, promotes muscular dysfunction resulting in increased muscle fat accumulation. The study of muscle function and intramyocellular lipids is insufficient for obesity. Particularly, the study of mechanisms in muscle function and intramyocellular lipids is few nationally and internationally.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is prospective study. The goal of this study is

  1. To examine the distribution and contractile properties (cross-sectional area, maximal force, specific force, maximal shortening velocity) of single muscle fiber sex/Myosin heavy chain (MHC) type-related differences, by extracting a single muscle fiber from the vastus lateralis in young men and women.
  2. To examine the effects of intramyocellular lipids on physical activity ability, muscle dysfunction, and metabolic disorders in relation to aging and obesity.
  3. To examine the effects of intramyocellular lipids on physical activity ability, muscular dysfunction, and metabolic disorders after 12 weeks resistance exercise intervention.

Study Type

Interventional

Enrollment (Actual)

28

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 Locations

  • Korea, Republic of
    • Gyeonggi
      • SeongNam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Young men: Age (20-35 yrs), BMI (19-23 Kg/m2)
  • Young women: Age (20-35 yrs), BMI (19-23 Kg/m2)
  • Elderly women: Age (65-80 yrs), BMI (19-23 Kg/m2)
  • Elderly obese women: Age (65-80 yrs), BMI ( >25 Kg/m2)
  • Subjects who can agree voluntarily.

Exclusion Criteria:

  • Acute coronary syndrome.
  • Uncontrolled hypertension.
  • Subjects who took drugs which can affects neuromuscular system.
  • Severely impaired cognition
  • Subjects who cannot agree voluntarily

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Young men
Range of age is 20-35 years, young men (BMI 19-23 Kg/m2) They did not suffer from musculoskeletal or metabolic diseases, and had not performed regular exercise within the previous 3 months.
No Intervention: Young women
Range of age is 20-35 years, young women (BMI 19-23 Kg/m2) They did not suffer from musculoskeletal or metabolic diseases, and had not performed regular exercise within the previous 3 months.
Experimental: Elderly women (control)
Range of age is 65-80 years, Elderly women (BMI 19-23 Kg/m2) They did not suffer from musculoskeletal or metabolic diseases, and had not performed regular exercise within the previous 3 months.
Other: Resistance exercise with a gym stick
Exercise intervention: The resistance exercise intervention is performed with a gym stick for 3 times a week for 12 weeks. Exercise load is gradually increased by the number of times the band is wound and the speed of motion by dividing into three stages in 1-4 weeks (1st stage), 5-8 weeks (2nd stage) and 9-12 weeks (3rd stage).
Other Names:
  • Exercise training
Experimental: Elderly obese women
Range of age is 65-80 years,Elderly obese women (BMI ≥25 Kg/m2) They did not suffer from musculoskeletal or metabolic diseases, and had not performed regular exercise within the previous 3 months.
Other: Resistance exercise with a gym stick
Exercise intervention: The resistance exercise intervention is performed with a gym stick for 3 times a week for 12 weeks. Exercise load is gradually increased by the number of times the band is wound and the speed of motion by dividing into three stages in 1-4 weeks (1st stage), 5-8 weeks (2nd stage) and 9-12 weeks (3rd stage).
Other Names:
  • Exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total droplet area
Time Frame: Before intervention / after 12weeks intervention
Change from baseline total droplet area to 12 weeks after initial assessment. Total droplet area is determined by Oil-red-O staining. After staining, the total area (µm2) is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention
Number of lipid droplets
Time Frame: Before intervention / after 12weeks intervention

Change from baseline number of lipid droplets to 12 weeks after initial assessment.

Number of lipid droplets determined by Oil-red-O staining. After staining, number of lipid droplets is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention
Single muscle fiber cross-sectional area (CSA)
Time Frame: Before intervention / after 12weeks intervention
Change from baseline CSA to 12 weeks after initial assessment. Chemically skinned vastus lateralis muscle fiber CSA (µm2) is measured by 3 dimensional microscopy. after analysis, CSA is compared the change after intervention from baseline.
Before intervention / after 12weeks intervention
Single muscle fiber maximal force (Po)
Time Frame: Before intervention / after 12weeks intervention
Change from baseline Po to 12 weeks after initial assessment. Chemically skinned vastus lateralis muscle fiber Po (mN) is measured by slack test procedure. after measurement, Po is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention
Single muscle fiber specific force (SF)
Time Frame: Before intervention / after 12weeks intervention
Change from baseline SF to 12 weeks after initial assessment. Chemically skinned vastus lateralis muscle fiber SF (kN/m2) is Po (kN) normalized by cross-sectional area (m2). SF is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention
Single muscle fiber maximal shortening velocity (Vo)
Time Frame: Before intervention / after 12weeks intervention

Change from baseline Vo to 12 weeks after initial assessment. Chemically skinned vastus lateralis muscle fiber Vo (FL/s) is measured by slack test procedure. The time required to take up the imposed slack was measured from the onset of the length step to the beginning of the tension redevelopment . For each amplitude of length, the fiber was reextended while relaxed to minimize nonuniformity of sarcomere length. A straight line was presented to a plot of length vs. time, using least-squares regression, and the slope of the line divided by the segment length was recorded as Vo for that fiber.

Vo is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention
Single muscle fiber MHC type distribution
Time Frame: Before intervention / after 12weeks intervention

Change from baseline fiber type distribution to 12 weeks after initial assessment.

The MHC composition of single fibers was determined by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE).

MHC type distribution is analyzed to compare the change after intervention from baseline.
Before intervention / after 12weeks intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand grip strength
Time Frame: Before intervention / after 12weeks intervention
Change from baseline hand grip strength to 12 weeks after initial assessment. Participants are tested while they were seated, their arms are against their sides, their elbows are flexed 90 degrees. Hand grip Strength is measured in kilograms (kg) using a hand-grip dynamometer. The maximum value from either hand is used for analysis.
Before intervention / after 12weeks intervention
Isokinetic knee extension strength
Time Frame: Before intervention / after 12weeks intervention

Change from baseline Knee extension strength to 12 weeks after initial assessment.

Isokinetic knee extension strength is measured in as peak torque achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 60° per second.
Before intervention / after 12weeks intervention

Collaborators and Investigators

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

Sponsor

Seoul National University Bundang Hospital

Collaborators

National Research Foundation of Korea

Investigators

  • Study Director: Jae-Youn Lim, Ph.D., Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 18, 2016

Primary Completion (Actual)

February 29, 2020

Study Completion (Actual)

February 29, 2020

Study Registration Dates

First Submitted

May 10, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (Actual)

May 15, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 10, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-1610-365-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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