Clinical trial NCT04600050: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Eccentric exercise
Stroke
Physical function
Muscle function
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: National Rehabilitation Center, Seoul, Korea
First posted: 2020-10-23
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Isokinetic knee extensor strength
timeFrame: Change from Baseline muscle function at 8 weeks of intervention.
measure: Short physical performance battery (SPPB) scores
timeFrame: Change from Baseline physical function at 8 weeks of intervention.
Secondary outcomes:
measure: Hand grip strength
timeFrame: Change from Baseline physical function at 8 weeks of intervention
measure: Isotonic knee power
timeFrame: Change from Baseline physical function at 8 weeks of intervention
measure: Isometric knee strength
timeFrame: Change from Baseline physical function at 8 weeks of intervention
measure: Isokinetic knee extensor eccentric strength
timeFrame: Change from Baseline muscle function at 8 weeks of intervention.
measure: Timed up and go
timeFrame: Change from Baseline physical function at 8 weeks of intervention.
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References:
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.
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.
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.
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.
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.
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.
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.
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.