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Effects of Eccentric Training Intervention in Older Adults

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ClinicalTrials.gov Identifier: NCT04099316
Recruitment Status : Recruiting
First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Collaborator:
National Research Foundation of Korea
Information provided by (Responsible Party):
Jae-Young Lim, Seoul National University Bundang Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Sarcopenia Device: Eccentric exercise Device: Conventional resistance exercise Not Applicable

Detailed Description:

This is prospective study. The goals of this study are to:

  1. Examine the effects of eccentric training on physical function (gait speed, stair climb, chair stand) in older adults.
  2. Examine the effects of eccentric training on muscle strength (Isometric strength, Isokinetic strength, power) in older adults.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Eccentric-based Training on Muscle Strength and Physical Function in Older Adults
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : October 31, 2019

Arm Intervention/treatment
Experimental: Older adults
Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.
Device: Eccentric exercise
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).

Experimental: Older adults-Control
Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.
Device: Conventional resistance exercise
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).

No Intervention: No intervention
Metabolic diseases, Hypertension (150/90mmHg), Myocardial infarction within 6 months. Fractures within 6 months.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Isokinetic knee strength [ Time Frame: Change from baseline isokinetic knee strength at 8 weeks ]

    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.


  2. Isometric knee strength [ Time Frame: Change from baseline isometric knee strength at 8 weeks ]
    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.

  3. Power [ Time Frame: Change from baseline power at 8 weeks ]

    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.




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Ages Eligible for Study:   60 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who can agree voluntarily
  • Older men/women: Age (60 - 80 yrs)

Exclusion Criteria:

  • Uncontrolled hypertension
  • Acute coronary syndrome
  • Subjects who took drugs which can affects neuromuscular system
  • 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): NCT04099316


Contacts
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Contact: Jae-Young Lim, Ph.D. +821053900373 drlim1@snu.ac.kr
Contact: Dae Young Kim, M.S. 821037570435 day22311@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Geyonggi, Korea, Republic of, 463-707
Contact: Jae-Young Lim, Ph.D.    +821053900373    drlim1@snu.ac.kr   
Contact: Dae Young Kim, M.S.    +821037570435    day22311@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
National Research Foundation of Korea
Publications:

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Responsible Party: Jae-Young Lim, Professor, Department of Rehabilitation Medicine, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT04099316    
Other Study ID Numbers: B-1705-397-004
First Posted: September 23, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 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
Eccentric training
Muscle strength
Physical function
Sarcopenia
Additional relevant MeSH terms:
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Sarcopenia
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical
Signs and Symptoms