Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

Study Overview
=================
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.

Official Title
-----------------
Effect of Eccentric Contraction-based Resistance Exercise on Functional Recovery in Chronic Stroke Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: usual care and exercise education
* Other: Eccentric exercise


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group: stroke patients with education<br> | Other: usual care and exercise education<br>* Provide exercise training materials after the education of exercise and health to enable home-based exercise<br>|
| Experimental: Experimental: stroke patients with exercise<br> | Other: Eccentric exercise<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from Baseline physical function at 8 weeks of intervention | 
| 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. | Change from Baseline physical function at 8 weeks of intervention | 
| 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. | Change from Baseline physical function at 8 weeks of intervention | 
| 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. | Change from Baseline muscle function at 8 weeks of intervention. | 
| 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. | Change from Baseline physical function at 8 weeks of intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Eccentric exercise, Stroke, Physical function, Muscle function