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Effects of Eccentric Training Intervention in Older Adults

Primary Purpose

Sarcopenia

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Eccentric exercise
Conventional resistance exercise
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sarcopenia focused on measuring Aging, Eccentric training, Muscle strength, Physical function, Sarcopenia

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Older adults

Older adults-Control

No intervention

Arm Description

Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.

Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.

Metabolic diseases, Hypertension (150/90mmHg), Myocardial infarction within 6 months. Fractures within 6 months.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
May 16, 2019
Last Updated
September 19, 2019
Sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04099316
Brief Title
Effects of Eccentric Training Intervention in Older Adults
Official Title
Effects of Eccentric-based Training on Muscle Strength and Physical Function in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2017 (Actual)
Primary Completion Date
September 30, 2019 (Anticipated)
Study Completion Date
October 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
National Research Foundation of Korea

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcopenia
Keywords
Aging, Eccentric training, Muscle strength, Physical function, Sarcopenia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Older adults
Arm Type
Experimental
Arm Description
Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.
Arm Title
Older adults-Control
Arm Type
Experimental
Arm Description
Older adults (Over the 60 years), Subjects did not suffer from musculoskeletal or metabolic diseases.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Metabolic diseases, Hypertension (150/90mmHg), Myocardial infarction within 6 months. Fractures within 6 months.
Intervention Type
Device
Intervention Name(s)
Eccentric exercise
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Conventional resistance exercise
Intervention Description
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).
Primary Outcome Measure Information:
Title
Gait speed
Description
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.
Time Frame
Change from baseline gaitspeed at 8 weeks
Title
Stair climb
Description
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.
Time Frame
Change from baseline stair climb at 8 weeks
Title
Chair stand
Description
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.
Time Frame
Change from baseline chair stand at 8 weeks
Secondary Outcome Measure Information:
Title
Isokinetic knee strength
Description
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.
Time Frame
Change from baseline isokinetic knee strength at 8 weeks
Title
Isometric knee strength
Description
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.
Time Frame
Change from baseline isometric knee strength at 8 weeks
Title
Power
Description
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.
Time Frame
Change from baseline power at 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Young Lim, Ph.D.
Phone
+821053900373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Dae Young Kim, M.S.
Phone
821037570435
Email
day22311@gmail.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Geyonggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, Ph.D.
Phone
+821053900373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Dae Young Kim, M.S.
Phone
+821037570435
Email
day22311@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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Effects of Eccentric Training Intervention in Older Adults

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