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Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

Primary Purpose

Stroke

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

About this trial

This is an interventional treatment trial for Stroke focused on measuring Eccentric exercise, Stroke, Physical function, Muscle function

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with disabilities 50 years of age or older who have been diagnosed with a stroke (ischemic and hemorrhagic cerebral hemorrhage) for at least one year
  • Patients can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher
  • Patients have a functional ambulation category (FAC) score of 3 to 5

Exclusion Criteria:

  • Patients with brain lesions and quadriplegia excluding stroke
  • Patients with uncontrolled hypertension with limited exercise intervention
  • Patients diagnosed with angina
  • Patients with congestive heart failure (CHF)
  • Patients with upper/lower extremity fracture within 6 months

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group: stroke patients with education

Experimental: stroke patients with exercise

Arm Description

Outcomes

Primary Outcome Measures

Isokinetic knee extensor strength
Evaluation of change from baseline isokinetic knee extensor strength to 8 weeks after the initial assessment. Isokinetic knee extensor strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 60° per second.
Short physical performance battery (SPPB) scores
Evaluation of change from baseline SPPB score to 8 weeks after the initial assessment. The SPPB is a group of measures that combine the results of the gait speed, timed chair stand and balance tests. For the static standing balance test, participants were asked to stand in side-by-side, semi-tandem and tandem positions, and maintain each position for 10 s. For the gait speed test, participants were asked to walk along a 4-m distance at their normal walking speed. For the repeated chair rise test, participants were asked to fold their arms across their chest and stand up from a sitting position five times consecutively as quickly as possible. Performance scores for each SPPB individual test and a summary score aggregating the individual tests were calculated as per standard SPPB protocol (range 0-12). The scores range from 0 (worst performance) to 12 (best performance).

Secondary Outcome Measures

Hand grip strength
Evaluation of change from baseline hand grip strength to 8 weeks after the 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 (Takei 5401, Tokyo, Japan). The maximum value from either hand is used for analysis.
Isotonic knee power
Evaluation of change from baseline isotonic knee power to 8 weeks after the initial assessment. knee extension and flexion were performed as quickly as possible during a period of 10 seconds and is measured in watts.
Isometric knee strength
Evaluation of change from baseline isometric knee strength to 8 weeks after the initial assessment. Isometric knee strength was measured in Newton-meters (Nm) using a baltimore therapeutic equipment (BTE) Primus RS (BTE Tech., Hanover, MD, USA). The participants were 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.
Isokinetic knee extensor eccentric strength
Evaluation of change from baseline isokinetic knee extensor eccentric strength to 8 weeks after the initial assessment. Isokinetic knee extensor eccentric strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 30° per second.
Timed up and go
Evaluation of change from baseline timed up and go to 8 weeks after the initial assessment. Participants sat on a chair and measured the time (second) that it took the participants to stand up, walk 3 m as quickly and safely as possible, turn around at a marked line on the floor, walk back, and sit down.

Full Information

First Posted
September 15, 2020
Last Updated
October 18, 2020
Sponsor
Seoul National University Bundang Hospital
Collaborators
National Rehabilitation Center, Seoul, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT04600050
Brief Title
Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients
Official Title
Effect of Eccentric Contraction-based Resistance Exercise on Functional Recovery in Chronic Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 11, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
National Rehabilitation Center, Seoul, 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
The purpose of this study is to develop an evidence-based rehabilitation treatment method suitable for recovery and improvement of physical function in chronic stroke patients using an eccentric overload flywheel device. Participants are disabled with chronic stroke (ischemic and hemorrhagic cerebral hemorrhage) over 50 years of age, who can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher, and whose functional gait score is 3-5 points. The investigators will enroll 40 participants and randomly assign them to either the control (Con, n=20) or the exercise (Ex, n=20) group. The investigators will verify the effectiveness of the exercise program through the evaluation of changes in muscle and physical function before and after intervention in both groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Eccentric exercise, Stroke, Physical function, Muscle function

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Control group: stroke patients with education
Arm Type
Active Comparator
Arm Title
Experimental: stroke patients with exercise
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
usual care and exercise education
Intervention Description
Provide exercise training materials after the education of exercise and health to enable home-based exercise
Intervention Type
Other
Intervention Name(s)
Eccentric exercise
Intervention Description
Under the face-to-face supervisor, the eccentric exercise using a flywheel, and the self-directed home-based eccentric overload exercise using an elastic band are performed.
Primary Outcome Measure Information:
Title
Isokinetic knee extensor strength
Description
Evaluation of change from baseline isokinetic knee extensor strength to 8 weeks after the initial assessment. Isokinetic knee extensor strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 60° per second.
Time Frame
Change from Baseline muscle function at 8 weeks of intervention.
Title
Short physical performance battery (SPPB) scores
Description
Evaluation of change from baseline SPPB score to 8 weeks after the initial assessment. The SPPB is a group of measures that combine the results of the gait speed, timed chair stand and balance tests. For the static standing balance test, participants were asked to stand in side-by-side, semi-tandem and tandem positions, and maintain each position for 10 s. For the gait speed test, participants were asked to walk along a 4-m distance at their normal walking speed. For the repeated chair rise test, participants were asked to fold their arms across their chest and stand up from a sitting position five times consecutively as quickly as possible. Performance scores for each SPPB individual test and a summary score aggregating the individual tests were calculated as per standard SPPB protocol (range 0-12). The scores range from 0 (worst performance) to 12 (best performance).
Time Frame
Change from Baseline physical function at 8 weeks of intervention.
Secondary Outcome Measure Information:
Title
Hand grip strength
Description
Evaluation of change from baseline hand grip strength to 8 weeks after the 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 (Takei 5401, Tokyo, Japan). The maximum value from either hand is used for analysis.
Time Frame
Change from Baseline physical function at 8 weeks of intervention
Title
Isotonic knee power
Description
Evaluation of change from baseline isotonic knee power to 8 weeks after the initial assessment. knee extension and flexion were performed as quickly as possible during a period of 10 seconds and is measured in watts.
Time Frame
Change from Baseline physical function at 8 weeks of intervention
Title
Isometric knee strength
Description
Evaluation of change from baseline isometric knee strength to 8 weeks after the initial assessment. Isometric knee strength was measured in Newton-meters (Nm) using a baltimore therapeutic equipment (BTE) Primus RS (BTE Tech., Hanover, MD, USA). The participants were 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.
Time Frame
Change from Baseline physical function at 8 weeks of intervention
Title
Isokinetic knee extensor eccentric strength
Description
Evaluation of change from baseline isokinetic knee extensor eccentric strength to 8 weeks after the initial assessment. Isokinetic knee extensor eccentric strength is measured in peak torque (Nm) achieved on an isokinetic dynamometer (BTE Primus, BTE tech, MD, USA) at 30° per second.
Time Frame
Change from Baseline muscle function at 8 weeks of intervention.
Title
Timed up and go
Description
Evaluation of change from baseline timed up and go to 8 weeks after the initial assessment. Participants sat on a chair and measured the time (second) that it took the participants to stand up, walk 3 m as quickly and safely as possible, turn around at a marked line on the floor, walk back, and sit down.
Time Frame
Change from Baseline physical function at 8 weeks of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with disabilities 50 years of age or older who have been diagnosed with a stroke (ischemic and hemorrhagic cerebral hemorrhage) for at least one year Patients can communicate with a Korean simple mental state test (MMSE-K) of 24 points or higher Patients have a functional ambulation category (FAC) score of 3 to 5 Exclusion Criteria: Patients with brain lesions and quadriplegia excluding stroke Patients with uncontrolled hypertension with limited exercise intervention Patients diagnosed with angina Patients with congestive heart failure (CHF) Patients with upper/lower extremity fracture within 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jae-Young Lim, M.D., Ph.D.
Phone
+821053900373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Seung-Lyul Oh, Ph.D.
Phone
+821043014212
Email
oh3328@gmail.com
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph.D.
Phone
+82-10-5390-0373
Email
drlim1@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jae-Young Lim, M.D., Ph. D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25192875
Citation
Anker SD, von Haehling S. Efforts begin to sprout: publications in JCSM on cachexia, sarcopenia and muscle wasting receive attention. J Cachexia Sarcopenia Muscle. 2014 Sep;5(3):171-6. doi: 10.1007/s13539-014-0158-6. Epub 2014 Sep 6. No abstract available. Erratum In: J Cachexia Sarcopenia Muscle. 2015 Jun;6(2):192.
Results Reference
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PubMed Identifier
27854226
Citation
Arvanitidis A, Henriksen K, Karsdal MA, Nedergaard A. Neo-epitope Peptides as Biomarkers of Disease Progression for Muscular Dystrophies and Other Myopathies. J Neuromuscul Dis. 2016 Aug 30;3(3):333-346. doi: 10.3233/JND-160150.
Results Reference
background
PubMed Identifier
22397710
Citation
Chang TF, Liou TH, Chen CH, Huang YC, Chang KH. Effects of elastic-band exercise on lower-extremity function among female patients with osteoarthritis of the knee. Disabil Rehabil. 2012;34(20):1727-35. doi: 10.3109/09638288.2012.660598. Epub 2012 Mar 8.
Results Reference
background
PubMed Identifier
21431924
Citation
Choi SJ, Lim JY, Nibaldi EG, Phillips EM, Frontera WR, Fielding RA, Widrick JJ. Eccentric contraction-induced injury to type I, IIa, and IIa/IIx muscle fibers of elderly adults. Age (Dordr). 2012 Feb;34(1):215-26. doi: 10.1007/s11357-011-9228-2. Epub 2011 Mar 24.
Results Reference
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PubMed Identifier
20303404
Citation
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.
Results Reference
background
PubMed Identifier
28462115
Citation
Lim 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.
Results Reference
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PubMed Identifier
22910301
Citation
Kim KE, Jang SN, Lim S, Park YJ, Paik NJ, Kim KW, Jang HC, Lim JY. Relationship between muscle mass and physical performance: is it the same in older adults with weak muscle strength? Age Ageing. 2012 Nov;41(6):799-803. doi: 10.1093/ageing/afs115. Epub 2012 Aug 21.
Results Reference
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PubMed Identifier
26017097
Citation
Kim YH, Kim KI, Paik NJ, Kim KW, Jang HC, Lim JY. Muscle strength: A better index of low physical performance than muscle mass in older adults. Geriatr Gerontol Int. 2016 May;16(5):577-85. doi: 10.1111/ggi.12514. Epub 2015 May 28.
Results Reference
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Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

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