- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02938416
The Effect of Isokinetic Strengthening Training
November 12, 2023 updated by: Yuan-Yang Cheng, Taichung Veterans General Hospital
Comparison of the Functional Recovery and Cytokines Changes Between Isokinetic and Isotonic Training in Patients With Acute Stroke, After Total Hip Replacement or After Total Knee Replacement
Our participants will include 40 patients within one month of stroke, 43 patients who received total hip replacement or total knee replacement two to four weeks before.
The participants will be randomly assigned to isokinetic, isotonic or isometric training groups.
Outcome measures including isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma concentration of hsCRP, and the level of substance P in saliva will be collected at the beginning and 4 weeks after the training program.
Statistical significant differences will be determined between the improvement of outcome measures of the isokinetic and the isotonic training groups.
Study Overview
Status
Recruiting
Conditions
Detailed Description
Our participants will include 40 patients within one month of stroke, 43 patients who received total hip replacement or total knee replacement two to four weeks before.
The participants will be randomly assigned to isokinetic, isotonic or isometric training groups.
Outcome measures including isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s, Short Form 36 (SF-36), the Timed Up and Go test, the Oxford Hip/knee Score, the plasma concentration of hsCRP, and the level of substance P in saliva will be collected at the beginning and 4 weeks after the training program.
Statistical significant differences will be determined between the
Study Type
Interventional
Enrollment (Estimated)
126
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: Yuan-Yang Cheng, MD, PhD
- Phone Number: 3500 +886-4-23592525
- Email: rifampin@gmail.com
Study Locations
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-
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Taichung City, Taiwan, 40705
- Recruiting
- Department of Physical Medicine and Rehabilitation
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Contact:
- Yuan-Yang Cheng, MD, PhD
- Phone Number: 3533 +886423592525
- Email: rifampin@gmail.com
-
Principal Investigator:
- Yuan-Yang Cheng, MD, PhD
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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
36 years to 66 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- within one month of acute stroke
- receive total hip/knee replacement within two to four weeks before
Exclusion Criteria:
- cannot perform from sitting to standing
- Body Mass Index > 30
- Lower limbs fracture history
- Diabetic polyneuropathy
- Cardiopulmonary diseases that impede exercise prescription
- Impaired cognitive function
- Infectious disease during the study period that may cause cytokine changes
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Isokinetic training
Ten times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec
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Isokinetic strengthening exercise provides muscle training throughout the range of motion of a joint at a pre-set constant speed of angular velocity.
It can be performed in an eccentric or concentric way in a controlled manner, and is evidenced to be an effective and safe training method in patients with anterior cruciate ligament reconstruction, burn injury, ankle instability, osteoarthritic knee, and chronic stroke in the past literatures.
|
|
Active Comparator: Isotonic training
Ten times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee
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Isotonic strengthening exercise keeps the tension remained unchanged during the muscle's length changing.
As the muscle's force changes via the length-tension relationship during a contraction, an isotonic contraction will keep force constant while velocity changes.
There are two types of isotonic contractions: (1) concentric and (2) eccentric.
In a concentric contraction, the muscle tension rises to meet the resistance, then remains the same as the muscle shortens.
In eccentric, the muscle lengthens due to the resistance being greater than the force the muscle is producing.
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Placebo Comparator: isometric training
home exercise education on isometric quadriceps strengthening on the day of out-patient appointment
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home exercise education on isometric quadriceps strengthening on the day of out-patient appointment
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak torque
Time Frame: 4 weeks
|
Isometric peak torque of hip/knee at 90 degree of flexion, peak torque of hip/knee at angular velocity of 60 degree/s and 120 degree/s
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4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Timed Up and Go test
Time Frame: 4 weeks
|
stand up from a chair, walk for 3 meters and go back and sit down
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4 weeks
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Short Form 36 (SF-36) questionnaire
Time Frame: 4 weeks
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Use the 36-item, patient-reported questionnaire to survey the self-perceived health status
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4 weeks
|
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Oxford Hip/Knee Score
Time Frame: 4 weeks
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symptoms score during daily activities
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4 weeks
|
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The plasma concentration of hsCRP, and the level of substance P in saliva
Time Frame: 4 weeks
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check by drawing blood and test
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuan-Yang Cheng, MD, PhD, Department of Physical Medicine and Rehabilitation
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.
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
January 1, 2013
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
October 18, 2016
First Submitted That Met QC Criteria
October 18, 2016
First Posted (Estimated)
October 19, 2016
Study Record Updates
Last Update Posted (Estimated)
November 14, 2023
Last Update Submitted That Met QC Criteria
November 12, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CF12251
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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