Effect of Aging & Obesity With Exercise Intervention

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951857
• Other study ID #: B-1610-365-001
• Status: Completed
• Phase: N/A
• Start date: November 18, 2016
• Est. completion date: February 29, 2020

Study information

• Verified date: March 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	SeongNam	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	National Research Foundation of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (18)

Addison O, Marcus RL, Lastayo PC, Ryan AS. Intermuscular fat: a review of the consequences and causes. Int J Endocrinol. 2014;2014:309570. doi: 10.1155/2014/309570. Epub 2014 Jan 8. Review. — View Citation

Choi SJ, Files DC, Zhang T, Wang ZM, Messi ML, Gregory H, Stone J, Lyles MF, Dhar S, Marsh AP, Nicklas BJ, Delbono O. Intramyocellular Lipid and Impaired Myofiber Contraction in Normal Weight and Obese Older Adults. J Gerontol A Biol Sci Med Sci. 2016 Apr;71(4):557-64. doi: 10.1093/gerona/glv169. Epub 2015 Sep 23. — View Citation

Doherty TJ, Vandervoort AA, Brown WF. Effects of ageing on the motor unit: a brief review. Can J Appl Physiol. 1993 Dec;18(4):331-58. Review. — View Citation

Goodpaster BH, Carlson CL, Visser M, Kelley DE, Scherzinger A, Harris TB, Stamm E, Newman AB. Attenuation of skeletal muscle and strength in the elderly: The Health ABC Study. J Appl Physiol (1985). 2001 Jun;90(6):2157-65. — View Citation

Goodpaster BH, Krishnaswami S, Resnick H, Kelley DE, Haggerty C, Harris TB, Schwartz AV, Kritchevsky S, Newman AB. Association between regional adipose tissue distribution and both type 2 diabetes and impaired glucose tolerance in elderly men and women. Diabetes Care. 2003 Feb;26(2):372-9. — View Citation

Goodpaster BH, Park SW, Harris TB, Kritchevsky SB, Nevitt M, Schwartz AV, Simonsick EM, Tylavsky FA, Visser M, Newman AB. The loss of skeletal muscle strength, mass, and quality in older adults: the health, aging and body composition study. J Gerontol A Biol Sci Med Sci. 2006 Oct;61(10):1059-64. — View Citation

Gorgey AS, Mather KJ, Cupp HR, Gater DR. Effects of resistance training on adiposity and metabolism after spinal cord injury. Med Sci Sports Exerc. 2012 Jan;44(1):165-74. doi: 10.1249/MSS.0b013e31822672aa. — View Citation

Hughes VA, Frontera WR, Wood M, Evans WJ, Dallal GE, Roubenoff R, Fiatarone Singh MA. Longitudinal muscle strength changes in older adults: influence of muscle mass, physical activity, and health. J Gerontol A Biol Sci Med Sci. 2001 May;56(5):B209-17. — View Citation

Koster A, Ding J, Stenholm S, Caserotti P, Houston DK, Nicklas BJ, You T, Lee JS, Visser M, Newman AB, Schwartz AV, Cauley JA, Tylavsky FA, Goodpaster BH, Kritchevsky SB, Harris TB; Health ABC study. Does the amount of fat mass predict age-related loss of lean mass, muscle strength, and muscle quality in older adults? J Gerontol A Biol Sci Med Sci. 2011 Aug;66(8):888-95. doi: 10.1093/gerona/glr070. Epub 2011 May 13. — View Citation

Lexell J, Taylor CC, Sjöström M. What is the cause of the ageing atrophy? Total number, size and proportion of different fiber types studied in whole vastus lateralis muscle from 15- to 83-year-old men. J Neurol Sci. 1988 Apr;84(2-3):275-94. — View Citation

Menshikova EV, Ritov VB, Fairfull L, Ferrell RE, Kelley DE, Goodpaster BH. Effects of exercise on mitochondrial content and function in aging human skeletal muscle. J Gerontol A Biol Sci Med Sci. 2006 Jun;61(6):534-40. — View Citation

Ryan AS, Ortmeyer HK, Sorkin JD. Exercise with calorie restriction improves insulin sensitivity and glycogen synthase activity in obese postmenopausal women with impaired glucose tolerance. Am J Physiol Endocrinol Metab. 2012 Jan 1;302(1):E145-52. doi: 10.1152/ajpendo.00618.2010. Epub 2011 Oct 18. — View Citation

Santanasto AJ, Glynn NW, Newman MA, Taylor CA, Brooks MM, Goodpaster BH, Newman AB. Impact of weight loss on physical function with changes in strength, muscle mass, and muscle fat infiltration in overweight to moderately obese older adults: a randomized clinical trial. J Obes. 2011;2011. pii: 516576. doi: 10.1155/2011/516576. Epub 2010 Oct 10. — View Citation

Tuttle LJ, Sinacore DR, Mueller MJ. Intermuscular adipose tissue is muscle specific and associated with poor functional performance. J Aging Res. 2012;2012:172957. doi: 10.1155/2012/172957. Epub 2012 May 14. — View Citation

Visser M, Goodpaster BH, Kritchevsky SB, Newman AB, Nevitt M, Rubin SM, Simonsick EM, Harris TB. Muscle mass, muscle strength, and muscle fat infiltration as predictors of incident mobility limitations in well-functioning older persons. J Gerontol A Biol Sci Med Sci. 2005 Mar;60(3):324-33. — View Citation

Visser M, Kritchevsky SB, Goodpaster BH, Newman AB, Nevitt M, Stamm E, Harris TB. Leg muscle mass and composition in relation to lower extremity performance in men and women aged 70 to 79: the health, aging and body composition study. J Am Geriatr Soc. 2002 May;50(5):897-904. — View Citation

Yim JE, Heshka S, Albu J, Heymsfield S, Kuznia P, Harris T, Gallagher D. Intermuscular adipose tissue rivals visceral adipose tissue in independent associations with cardiovascular risk. Int J Obes (Lond). 2007 Sep;31(9):1400-5. Epub 2007 Apr 24. — View Citation

Yoshida Y, Marcus RL, Lastayo PC. Intramuscular adipose tissue and central activation in older adults. Muscle Nerve. 2012 Nov;46(5):813-6. doi: 10.1002/mus.23506. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total droplet area	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
Primary	Number of lipid droplets	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
Primary	Single muscle fiber cross-sectional area (CSA)	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
Primary	Single muscle fiber maximal force (Po)	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
Primary	Single muscle fiber specific force (SF)	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
Primary	Single muscle fiber maximal shortening velocity (Vo)	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 ?ber 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 ?ber.; Vo is analyzed to compare the change after intervention from baseline.	Before intervention / after 12weeks intervention
Primary	Single muscle fiber MHC type distribution	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	Hand grip strength	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
Secondary	Isokinetic knee extension strength	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