Eccentric Contraction-based Resistance Exercise for Chronic Stroke Patients

October 18, 2020 updated by: Jae-Young Lim, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae-Young Lim, M.D., Ph.D.
  • Phone Number: +821053900373
  • Email: drlim1@snu.ac.kr

Study Contact Backup

  • Name: Seung-Lyul Oh, Ph.D.
  • Phone Number: +821043014212
  • Email: oh3328@gmail.com

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Isokinetic knee extensor strength
Time Frame: Change from Baseline muscle function at 8 weeks of intervention.
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
Time Frame: Change from Baseline physical function at 8 weeks of intervention.
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
Time Frame: Change from Baseline physical function at 8 weeks of intervention
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
Time Frame: Change from Baseline physical function at 8 weeks of intervention
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
Time Frame: Change from Baseline physical function at 8 weeks of intervention
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
Time Frame: Change from Baseline muscle function at 8 weeks of intervention.
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
Time Frame: Change from Baseline physical function at 8 weeks of intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

National Rehabilitation Center, Seoul, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

January 31, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

October 18, 2020

First Posted (Actual)

October 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 18, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRCRSP-EX20010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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