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Effect of Aging & Obesity With Exercise Intervention

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ClinicalTrials.gov Identifier: NCT03951857
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Jae-Young Lim, Seoul National University Bundang Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Resistance exercise with a gym stick Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Biphasic and Combined Effect of Aging & Obesity With Development of Effective Exercise Intervention Protocol
Actual Study Start Date : November 18, 2016
Estimated Primary Completion Date : May 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Exercise training




Primary Outcome Measures :
  1. 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.

  2. 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.


  3. 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.

  4. 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.

  5. 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.

  6. 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.


  7. 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.



Secondary Outcome Measures :
  1. 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.

  2. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  

This study is divided into two purposes.

  1. To examine the distribution and contractile properties (CSA, Po, SF, Vo) of single muscle fiber sex/MHC type-related differences in youn men and women.
  2. To examine effects of 12-week resistance exercise on single muscle fiber funtion and intramyocellular lipids in aging and obese elderly women.

For the purposes of the first study, young men and women (age 20-35 yrs) should be participated in this study.

aimed to examine the distribution and contractile properties (CSA, Po, SF, Vo) of single muscle fiber sex/MHC type-related differences, by extracting a single muscle fiber from the vastus lateralis in young men and women

Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951857


Contacts
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Contact: Jae-Young Lim, Ph.D. +821053900373 drlim1@snu.ac.kr
Contact: Yunah Jeon, Ph.D. +821042861219 sister16@naver.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
SeongNam, Gyeonggi, Korea, Republic of, 463-707
Contact: Jae-Young Lim, Ph.D.    +821053900373 ext +821053900373    drlim1@snu.ac.kr   
Contact: Yunah Jeon, Ph.D.    +821042861219 ext +821042861219    sister16@naver.com   
Principal Investigator: Jae-Young Lim, Ph.D.         
Sub-Investigator: Yunah Jeon, Ph.D         
Sponsors and Collaborators
Seoul National University Bundang Hospital
National Research Foundation of Korea
Investigators
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Study Director: Jae-Youn Lim, Ph.D. Seoul National University Bundang Hospital

Publications:

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Responsible Party: Jae-Young Lim, Professor, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03951857     History of Changes
Other Study ID Numbers: B-1610-365-001
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jae-Young Lim, Seoul National University Bundang Hospital:
Aging
Obesity
Single muscle fiber contractile properties
Intramyocellular lipids
Resistance exercise

Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms