Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

NCT04600050 | Unknown DMC

• 1 other identifier: NRCRSP-EX20010
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Eccentric exercise; Stroke; Physical function; Muscle function

Outcome Measures

Primary Outcomes (2)

• 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.

  Change from Baseline muscle function at 8 weeks of intervention.

• 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).

  Change from Baseline physical function at 8 weeks of intervention.

Secondary Outcomes (5)

• Hand grip strength

  Change from Baseline physical function at 8 weeks of intervention

• Isotonic knee power

  Change from Baseline physical function at 8 weeks of intervention

• Isometric knee strength

  Change from Baseline physical function at 8 weeks of intervention

• Isokinetic knee extensor eccentric strength

  Change from Baseline muscle function at 8 weeks of intervention.

• Timed up and go

  Change from Baseline physical function at 8 weeks of intervention.

Study Arms (2)

Control group: stroke patients with education

ACTIVE COMPARATOR

Other: usual care and exercise education

Experimental: stroke patients with exercise

EXPERIMENTAL

Other: Eccentric exercise

Interventions

usual care and exercise education OTHER

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

Control group: stroke patients with education

Eccentric exercise 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.

Experimental: stroke patients with exercise

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead
• National Rehabilitation Center, Seoul, Korea: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

RECRUITING

Related Publications (9)

• 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.

  PMID: 25192875 BACKGROUND

• 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.

  PMID: 27854226 BACKGROUND

• 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.

  PMID: 22397710 BACKGROUND

• 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.

  PMID: 21431924 BACKGROUND

• 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.

  PMID: 20303404 BACKGROUND

• 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.

  PMID: 28462115 BACKGROUND

• 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.

  PMID: 22910301 BACKGROUND

• 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.

  PMID: 26017097 BACKGROUND

• 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.

  PMID: 40797445 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

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

CONTACT

+821053900373; drlim1@snu.ac.kr

Seung-Lyul Oh, Ph.D.

CONTACT

+821043014212; oh3328@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Rehabilitation Medicine

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 23, 2020
• Study Start: August 11, 2020
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)