ObesityNCT03951857
Effect of Aging & Obesity With Exercise Intervention
A study testing Resistance exercise with a gym stick in people with Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Resistance exercise with a gym stick
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Nov 2016to 29 Feb 2020
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Acute coronary syndrome.
- Uncontrolled hypertension.
- Subjects who took drugs which can affects neuromuscular system.
- Severely impaired cognition
- Subjects who cannot agree voluntarily
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
About this study
Official title: 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.
Read the detailed description
This study is prospective study. The goal of this study is
- 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.
- To examine the effects of intramyocellular lipids on physical activity ability, muscle dysfunction, and metabolic disorders in relation to aging and obesity.
- To examine the effects of intramyocellular lipids on physical activity ability, muscular dysfunction, and metabolic disorders after 12 weeks resistance exercise intervention.
- Conditions
- Obesity
- Being tested
- Resistance exercise with a gym stick
- Keywords
- Aging, Obesity, Single muscle fiber contractile properties, Intramyocellular lipids, Resistance exercise
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise with a gym stickOther
Also called Exercise training
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).
| Study group | Role | What they receive |
|---|---|---|
| Young men | No intervention | 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. |
| Young women | No intervention | 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. |
| Elderly women (control) | Experimental | 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. Receives: Other: Resistance exercise with a gym stick |
| Elderly obese women | Experimental | 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. Receives: Other: Resistance exercise with a gym stick |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
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 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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
Secondary outcomes (2)
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.
Measured: Before intervention / after 12weeks intervention
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.
Measured: Before intervention / after 12weeks intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start18 Nov 2016
- Primary completion29 Feb 2020
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Jae-Young Lim, Seoul National University Bundang Hospital
- Investigators
- Jae-Youn Lim, Ph.D., Study director, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03951857
- Sponsor's protocol ID
- B-1610-365-001
- Status last verified
- Mar 2020
- First submitted
- 10 May 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lexell J, Taylor CC, Sjostrom 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. doi: 10.1016/0022-510x(88)90132-3.
PubMed 3379447Doherty 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. doi: 10.1139/h93-029.
PubMed 8275048Goodpaster 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. doi: 10.1093/gerona/61.10.1059.
PubMed 17077199Hughes 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. doi: 10.1093/gerona/56.5.b209.
PubMed 11320101Goodpaster 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. doi: 10.2337/diacare.26.2.372.
PubMed 12547865Tuttle 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.
PubMed 22666591Yim 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. doi: 10.1038/sj.ijo.0803621. Epub 2007 Apr 24.
PubMed 17452994Visser 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. doi: 10.1046/j.1532-5415.2002.50217.x.
PubMed 12028178Koster 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.
PubMed 21572082Addison 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.
PubMed 24527032Goodpaster 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. doi: 10.1152/jappl.2001.90.6.2157.
PubMed 11356778Yoshida 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.
PubMed 23055318Visser 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. doi: 10.1093/gerona/60.3.324.
PubMed 15860469Ryan 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.
PubMed 22008454Santanasto 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;2011:516576. doi: 10.1155/2011/516576. Epub 2010 Oct 10.
PubMed 20953373
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biphasic and Combined Effect of Aging & Obesity With Development of Effective Exercise Intervention Protocol
- ClinicalTrials.gov ID
- NCT03951857
- Acronym / sponsor ID
- B-1610-365-001
- Conditions
- Obesity
- Keywords
- Aging, Obesity, Single muscle fiber contractile properties, Intramyocellular lipids, Resistance exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 18 Nov 2016 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 15 May 2019 (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.
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.
Detailed description
This study is prospective study. The goal of this study is
- 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.
- To examine the effects of intramyocellular lipids on physical activity ability, muscle dysfunction, and metabolic disorders in relation to aging and obesity.
- To examine the effects of intramyocellular lipids on physical activity ability, muscular dysfunction, and metabolic disorders after 12 weeks resistance exercise intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Young men | No intervention | –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. |
| Young women | No intervention | –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. |
| Elderly women (control) | Experimental | Other: Resistance exercise with a gym stickRange 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. |
| Elderly obese women | Experimental | Other: Resistance exercise with a gym stickRange 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Acute coronary syndrome.
- Uncontrolled hypertension.
- Subjects who took drugs which can affects neuromuscular system.
- Severely impaired cognition
- Subjects who cannot agree voluntarily
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 |
|---|---|---|
| Resistance exercise with a gym stickAlso: Exercise trainingExercise 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 | Elderly obese women, Elderly women (control) |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
2 secondary outcomes
Hand grip strength
Time frame: Before intervention / after 12weeks intervention
Isokinetic knee extension strength
Time frame: Before intervention / after 12weeks intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 3379447Lexell J, Taylor CC, Sjostrom 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. doi: 10.1016/0022-510x(88)90132-3.
- Background: PubMed 8275048Doherty 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. doi: 10.1139/h93-029.
- Background: PubMed 17077199Goodpaster 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. doi: 10.1093/gerona/61.10.1059.
- Background: PubMed 11320101Hughes 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. doi: 10.1093/gerona/56.5.b209.
- Background: PubMed 12547865Goodpaster 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. doi: 10.2337/diacare.26.2.372.
- Background: PubMed 22666591Tuttle 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.
- Background: PubMed 17452994Yim 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. doi: 10.1038/sj.ijo.0803621. Epub 2007 Apr 24.
- Background: PubMed 12028178Visser 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. doi: 10.1046/j.1532-5415.2002.50217.x.
- Background: PubMed 21572082Koster 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.
- Background: PubMed 24527032Addison 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.
- Background: PubMed 11356778Goodpaster 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. doi: 10.1152/jappl.2001.90.6.2157.
- Background: PubMed 23055318Yoshida 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.
- Individual participant dataSharing planned: No
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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.
Jae-Youn Lim, Ph.D. study director
Seoul National University Bundang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise with a gym stick in people with Obesity, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 11 Mar 2020. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total droplet area (time frame: Before intervention / after 12weeks intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03951857, which also lists 18 linked publications.
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 11 Mar 2020.