Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

NCT ID: NCT04600050

Last Updated: 2020-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-11

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control group: stroke patients with education

Group Type ACTIVE_COMPARATOR

usual care and exercise education

Intervention Type OTHER

Provide exercise training materials after the education of exercise and health to enable home-based exercise

Experimental: stroke patients with exercise

Group Type EXPERIMENTAL

Eccentric exercise

Intervention Type OTHER

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.

Interventions

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usual care and exercise education

Provide exercise training materials after the education of exercise and health to enable home-based exercise

Intervention Type OTHER

Eccentric exercise

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jae-Young Lim

Professor, Department of Rehabilitation Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jae-Young Lim, M.D., Ph.D.

Role: CONTACT

+821053900373

Seung-Lyul Oh, Ph.D.

Role: CONTACT

+821043014212

Facility Contacts

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Jae-Young Lim, M.D., Ph.D.

Role: primary

+82-10-5390-0373

References

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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.

Reference Type BACKGROUND
PMID: 25192875 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27854226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22397710 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21431924 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20303404 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28462115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22910301 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26017097 (View on PubMed)

Kim Y, Oh S, Kim DY, Lim JY. Effects of eccentric contraction-based resistance exercise on physical performance in chronic stroke patients: A randomized controlled trial. Medicine (Baltimore). 2025 Aug 8;104(32):e43491. doi: 10.1097/MD.0000000000043491.

Reference Type DERIVED
PMID: 40797445 (View on PubMed)

Other Identifiers

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NRCRSP-EX20010

Identifier Type: -

Identifier Source: org_study_id