SarcopeniaNCT04099316
Effects of Eccentric Training Intervention in Older Adults
A study testing Eccentric exercise and Conventional resistance exercise in people with Sarcopenia, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Sarcopenia leads to loss of muscle mass and muscle strength during the aging process. It has been reported that eccentric training has some positive effects on the preservation of eccentric strength, with less delayed onset muscle soreness (DOMS) in older groups, and lower metabolic costs. Read more about this study
- Who is it for?
- Ages 60 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia
- What is being tested?
- Eccentric exercise and Conventional resistance exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jul 2017to 31 Oct 2019
- 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 60 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects who can agree voluntarily
- Older men/women: Age (60 - 80 yrs)
Who cannot join
- Uncontrolled hypertension
- Acute coronary syndrome
- Subjects who took drugs which can affects neuromuscular system
- Subjects who cannot agree voluntarily
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, Geyonggi, 463-707
Jae-Young Lim, Ph.D., +821053900373, drlim1@snu.ac.kr
Dae Young Kim, M.S., +821037570435, day22311@gmail.com
About this study
Official title: Effects of Eccentric-based Training on Muscle Strength and Physical Function in Older Adults
Sarcopenia leads to loss of muscle mass and muscle strength during the aging process. It has been reported that eccentric training has some positive effects on the preservation of eccentric strength, with less delayed onset muscle soreness (DOMS) in older groups, and lower metabolic costs.
Read the detailed description
This is prospective study. The goals of this study are to:
- Examine the effects of eccentric training on physical function (gait speed, stair climb, chair stand) in older adults.
- Examine the effects of eccentric training on muscle strength (Isometric strength, Isokinetic strength, power) in older adults.
- Conditions
- Sarcopenia
- Being tested
- Eccentric exercise, Conventional resistance exercise
- Keywords
- Aging, Eccentric training, Muscle strength, Physical function, Sarcopenia
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric exerciseDevice
Eccentric exercise with Eccentron electronic device. Exercise intervention: The exercise intervention is performed to twice a week (Total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage),(5-8 weeks; 2nd stage).
Conventional resistance exerciseDevice
Leg press exercise with leg press machine. Exercise intervention: The exercise intervention is performed to twice a week (total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage), (5-8 weeks; 2nd stage).
| Study group | Role | What they receive |
|---|---|---|
| Older adults | Experimental | Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases. Receives: Device: Eccentric exercise |
| Older adults-Control | Experimental | Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases. Receives: Device: Conventional resistance exercise |
| No intervention | No intervention | Metabolic diseases, Hypertension (150/90mmHg), Myocardial infarction within 6 months. Fractures within 6 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait speed
An examiner used a stopwatch to time how long it took subjects to walk along a marked tape. The Kinect device was used to measure gait speed.
Measured: Change from baseline gaitspeed at 8 weeks
Stair climb
Subjects were measured on eight 17-cm stairs twice, requiring a step by step pattern, where the timer activated when the first contact was made at the first step and ended when the contact occurred at the last step before and after the 8 weeks of exercise training.
Measured: Change from baseline stair climb at 8 weeks
Chair stand
Subjects had to get up from a chair measuring 41 cm in height with a flat seat. Subjects were asked to stand up and sit down 5 times as quickly as possible with their arms folded across the chest. They stood up until full extension was observed at the trunk and lower limb joints, and returned to a seated position with their back fully supported at the back of the chair.
Measured: Change from baseline chair stand at 8 weeks
Secondary outcomes (3)
Isokinetic knee strength
The isokinetic was measured using a baltimore therapeutic equipment (BTE) Primus RS (BTE Tech., Hanover, MD, USA). The subject performed a 60 degree per second knee flexion and extension five times. Each isokinetic contraction was performed through a full range of motion.Before each subject began the isokinetic test, the subject warmed up using a 50-60% knee extension/flexion once.
Isokinetic knee strength is measured in as peak torque achieved on an isokinetic dynamometer (BTE PrimusRS, BTE tech, MD, USA) at 60 degree per second.
Measured: Change from baseline isokinetic knee strength at 8 weeks
Isometric knee strength
Isometric knee strength was measured using a baltimore therapeutic equipment (BTE) Primus RS (BTE Tech., Hanover, MD, USA). The subject was asked to sit on the treatment chair and a standard stabilization strap was placed on the upper ankle. The knee was kept at 90 degree flexion, and the foot was positioned in dorsi flexion. The subject's hands were placed on the edge of the side of the chair and the trunk, hips, and mid-thigh were stabilized in the chair by the straps.
Measured: Change from baseline isometric knee strength at 8 weeks
Power
The test used same machine as the isometric and isokinetic tests. The ankle was placed in a neutral position, and the subjects performed a range of motion for 10 seconds, once. After the warm up, knee extension and flexion were performed as quickly as possible during a period of 10 seconds.
Isokinetic knee strength is measured in as peak torque achieved on an isokinetic dynamometer (BTE PrimusRS, BTE tech, MD, USA) at 60 degree per second.
Measured: Change from baseline power at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2019
- Study start20 Jul 2017
- Primary completion30 Sep 2019 (estimated)
- Study completion31 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 27 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04099316
- Sponsor's protocol ID
- B-1705-397-004
- Status last verified
- Sep 2019
- First submitted
- 16 May 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roig M, Macintyre DL, Eng JJ, Narici MV, Maganaris CN, Reid WD. Preservation of eccentric strength in older adults: Evidence, mechanisms and implications for training and rehabilitation. Exp Gerontol. 2010 Jun;45(6):400-9. doi: 10.1016/j.exger.2010.03.008. Epub 2010 Mar 18.
PubMed 20303404Frontera WR, Hughes VA, Krivickas LS, Roubenoff R. Contractile properties of aging skeletal muscle. Int J Sport Nutr Exerc Metab. 2001 Dec;11 Suppl:S16-20. doi: 10.1123/ijsnem.11.s1.s16. No abstract available.
PubMed 11915915Frontera WR, Reid KF, Phillips EM, Krivickas LS, Hughes VA, Roubenoff R, Fielding RA. Muscle fiber size and function in elderly humans: a longitudinal study. J Appl Physiol (1985). 2008 Aug;105(2):637-42. doi: 10.1152/japplphysiol.90332.2008. Epub 2008 Jun 12.
PubMed 18556434Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.
PubMed 23327448Chen TC, Tseng WC, Huang GL, Chen HL, Tseng KW, Nosaka K. Superior Effects of Eccentric to Concentric Knee Extensor Resistance Training on Physical Fitness, Insulin Sensitivity and Lipid Profiles of Elderly Men. Front Physiol. 2017 Apr 10;8:209. doi: 10.3389/fphys.2017.00209. eCollection 2017.
PubMed 28443029Dias CP, Toscan R, de Camargo M, Pereira EP, Griebler N, Baroni BM, Tiggemann CL. Effects of eccentric-focused and conventional resistance training on strength and functional capacity of older adults. Age (Dordr). 2015 Oct;37(5):99. doi: 10.1007/s11357-015-9838-1. Epub 2015 Sep 15.
PubMed 26374635Enoka RM. Eccentric contractions require unique activation strategies by the nervous system. J Appl Physiol (1985). 1996 Dec;81(6):2339-46. doi: 10.1152/jappl.1996.81.6.2339.
PubMed 9018476Gault ML, Willems ME. Aging, functional capacity and eccentric exercise training. Aging Dis. 2013 Sep 25;4(6):351-63. doi: 10.14336/AD.2013.0400351.
PubMed 24307968Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
PubMed 19910811LaStayo P, Marcus R, Dibble L, Wong B, Pepper G. Eccentric versus traditional resistance exercise for older adult fallers in the community: a randomized trial within a multi-component fall reduction program. BMC Geriatr. 2017 Jul 17;17(1):149. doi: 10.1186/s12877-017-0539-8.
PubMed 28716003Lim JY. Therapeutic potential of eccentric exercises for age-related muscle atrophy. Integr Med Res. 2016 Sep;5(3):176-181. doi: 10.1016/j.imr.2016.06.003. Epub 2016 Jun 18.
PubMed 28462115Mueller M, Breil FA, Vogt M, Steiner R, Lippuner K, Popp A, Klossner S, Hoppeler H, Dapp C. Different response to eccentric and concentric training in older men and women. Eur J Appl Physiol. 2009 Sep;107(2):145-53. doi: 10.1007/s00421-009-1108-4. Epub 2009 Jun 20.
PubMed 19543908Orer GE, Guzel NA, Arslan E. Recovery levels after eccentric and concentric loading in maximal force. J Phys Ther Sci. 2016 Jun;28(6):1743-7. doi: 10.1589/jpts.28.1743. Epub 2016 Jun 28.
PubMed 27390407Raj IS, Bird SR, Westfold BA, Shield AJ. Effects of eccentrically biased versus conventional weight training in older adults. Med Sci Sports Exerc. 2012 Jun;44(6):1167-76. doi: 10.1249/MSS.0b013e3182442ecd.
PubMed 22143107Roig M, O'Brien K, Kirk G, Murray R, McKinnon P, Shadgan B, Reid WD. The effects of eccentric versus concentric resistance training on muscle strength and mass in healthy adults: a systematic review with meta-analysis. Br J Sports Med. 2009 Aug;43(8):556-68. doi: 10.1136/bjsm.2008.051417. Epub 2008 Nov 3.
PubMed 18981046
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Eccentric-based Training on Muscle Strength and Physical Function in Older Adults
- ClinicalTrials.gov ID
- NCT04099316
- Acronym / sponsor ID
- B-1705-397-004
- Conditions
- Sarcopenia
- Keywords
- Aging, Eccentric training, Muscle strength, Physical function, Sarcopenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 20 Jul 2017 (actual)
- Primary completion
- 30 Sep 2019 (estimated)
- Study completion
- 31 Oct 2019 (estimated)
- First posted
- 23 Sep 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.
Sarcopenia leads to loss of muscle mass and muscle strength during the aging process. It has been reported that eccentric training has some positive effects on the preservation of eccentric strength, with less delayed onset muscle soreness (DOMS) in older groups, and lower metabolic costs.
Detailed description
This is prospective study. The goals of this study are to:
- Examine the effects of eccentric training on physical function (gait speed, stair climb, chair stand) in older adults.
- Examine the effects of eccentric training on muscle strength (Isometric strength, Isokinetic strength, power) in older adults.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older adults | Experimental | Device: Eccentric exerciseOlder adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases. |
| Older adults-Control | Experimental | Device: Conventional resistance exerciseOlder adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases. |
| No intervention | No intervention | –Metabolic diseases, Hypertension (150/90mmHg), Myocardial infarction within 6 months. Fractures within 6 months. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who can agree voluntarily
- Older men/women: Age (60 - 80 yrs)
Key exclusion criteria (4 listed)
- Uncontrolled hypertension
- Acute coronary syndrome
- Subjects who took drugs which can affects neuromuscular system
- 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 |
|---|---|---|
| Eccentric exerciseEccentric exercise with Eccentron electronic device. Exercise intervention: The exercise intervention is performed to twice a week (Total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage),(5-8 weeks; 2nd stage). | Device | Older adults |
| Conventional resistance exerciseLeg press exercise with leg press machine. Exercise intervention: The exercise intervention is performed to twice a week (total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage), (5-8 weeks; 2nd stage). | Device | Older adults-Control |
Primary outcome
Gait speed
Time frame: Change from baseline gaitspeed at 8 weeks
An examiner used a stopwatch to time how long it took subjects to walk along a marked tape. The Kinect device was used to measure gait speed.
Stair climb
Time frame: Change from baseline stair climb at 8 weeks
Subjects were measured on eight 17-cm stairs twice, requiring a step by step pattern, where the timer activated when the first contact was made at the first step and ended when the contact occurred at the last step before and after the 8 weeks of exercise training.
Chair stand
Time frame: Change from baseline chair stand at 8 weeks
Subjects had to get up from a chair measuring 41 cm in height with a flat seat. Subjects were asked to stand up and sit down 5 times as quickly as possible with their arms folded across the chest. They stood up until full extension was observed at the trunk and lower limb joints, and returned to a seated position with their back fully supported at the back of the chair.
3 secondary outcomes
Isokinetic knee strength
Time frame: Change from baseline isokinetic knee strength at 8 weeks
Isometric knee strength
Time frame: Change from baseline isometric knee strength at 8 weeks
Power
Time frame: Change from baseline power at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Background: PubMed 20303404Roig M, Macintyre DL, Eng JJ, Narici MV, Maganaris CN, Reid WD. Preservation of eccentric strength in older adults: Evidence, mechanisms and implications for training and rehabilitation. Exp Gerontol. 2010 Jun;45(6):400-9. doi: 10.1016/j.exger.2010.03.008. Epub 2010 Mar 18.
- Background: PubMed 11915915Frontera WR, Hughes VA, Krivickas LS, Roubenoff R. Contractile properties of aging skeletal muscle. Int J Sport Nutr Exerc Metab. 2001 Dec;11 Suppl:S16-20. doi: 10.1123/ijsnem.11.s1.s16. No abstract available.
- Background: PubMed 18556434Frontera WR, Reid KF, Phillips EM, Krivickas LS, Hughes VA, Roubenoff R, Fielding RA. Muscle fiber size and function in elderly humans: a longitudinal study. J Appl Physiol (1985). 2008 Aug;105(2):637-42. doi: 10.1152/japplphysiol.90332.2008. Epub 2008 Jun 12.
- Background: PubMed 23327448Cadore EL, Rodriguez-Manas L, Sinclair A, Izquierdo M. Effects of different exercise interventions on risk of falls, gait ability, and balance in physically frail older adults: a systematic review. Rejuvenation Res. 2013 Apr;16(2):105-14. doi: 10.1089/rej.2012.1397.
- Background: PubMed 28443029Chen TC, Tseng WC, Huang GL, Chen HL, Tseng KW, Nosaka K. Superior Effects of Eccentric to Concentric Knee Extensor Resistance Training on Physical Fitness, Insulin Sensitivity and Lipid Profiles of Elderly Men. Front Physiol. 2017 Apr 10;8:209. doi: 10.3389/fphys.2017.00209. eCollection 2017.
- Background: PubMed 26374635Dias CP, Toscan R, de Camargo M, Pereira EP, Griebler N, Baroni BM, Tiggemann CL. Effects of eccentric-focused and conventional resistance training on strength and functional capacity of older adults. Age (Dordr). 2015 Oct;37(5):99. doi: 10.1007/s11357-015-9838-1. Epub 2015 Sep 15.
- Background: PubMed 9018476Enoka RM. Eccentric contractions require unique activation strategies by the nervous system. J Appl Physiol (1985). 1996 Dec;81(6):2339-46. doi: 10.1152/jappl.1996.81.6.2339.
- Background: PubMed 24307968Gault ML, Willems ME. Aging, functional capacity and eccentric exercise training. Aging Dis. 2013 Sep 25;4(6):351-63. doi: 10.14336/AD.2013.0400351.
- Background: PubMed 19910811Hanson ED, Srivatsan SR, Agrawal S, Menon KS, Delmonico MJ, Wang MQ, Hurley BF. Effects of strength training on physical function: influence of power, strength, and body composition. J Strength Cond Res. 2009 Dec;23(9):2627-37. doi: 10.1519/JSC.0b013e3181b2297b.
- Background: PubMed 28716003LaStayo P, Marcus R, Dibble L, Wong B, Pepper G. Eccentric versus traditional resistance exercise for older adult fallers in the community: a randomized trial within a multi-component fall reduction program. BMC Geriatr. 2017 Jul 17;17(1):149. doi: 10.1186/s12877-017-0539-8.
- Background: PubMed 28462115Lim JY. Therapeutic potential of eccentric exercises for age-related muscle atrophy. Integr Med Res. 2016 Sep;5(3):176-181. doi: 10.1016/j.imr.2016.06.003. Epub 2016 Jun 18.
- Background: PubMed 19543908Mueller M, Breil FA, Vogt M, Steiner R, Lippuner K, Popp A, Klossner S, Hoppeler H, Dapp C. Different response to eccentric and concentric training in older men and women. Eur J Appl Physiol. 2009 Sep;107(2):145-53. doi: 10.1007/s00421-009-1108-4. Epub 2009 Jun 20.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric exercise and Conventional resistance exercise in people with Sarcopenia, 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Sep 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae-Young Lim, Ph.D. (+821053900373, drlim1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait speed (time frame: Change from baseline gaitspeed at 8 weeks). The study lists 3 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 NCT04099316, which also lists 17 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 23 Sep 2019.