The Effect of Isokinetic Strengthening Training
Primary Purpose
Resistance Training, Stroke, Arthroplasty, Replacement, Hip
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Isokinetic strengthening exercise
Isotonic strengthening exercise
Sponsored by
About this trial
This is an interventional treatment trial for Resistance Training
Eligibility Criteria
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
Sites / Locations
- Department of Physical Medicine and RehabilitationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Isokinetic training
Isotonic training
Arm Description
Ten times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec
Ten times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee
Outcomes
Primary Outcome Measures
Peak torque
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
Secondary Outcome Measures
Timed Up and Go test
stand up from a chair, walk for 3 meters and go back and sit down
Short Form 36 (SF-36) questionnaire
Use the 36-item, patient-reported questionnaire to survey the self-perceived health status
Oxford Hip/Knee Score
symptoms score during daily activities
The plasma concentration of hsCRP, and the level of substance P in saliva
check by drawing blood and test
Full Information
NCT ID
NCT02938416
First Posted
October 18, 2016
Last Updated
April 25, 2022
Sponsor
Taichung Veterans General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02938416
Brief Title
The Effect of Isokinetic Strengthening Training
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taichung Veterans General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Our participants will include 40 patients within one month of stroke, 40 patients who received total hip replacement or total knee replacement two to four weeks before. The participants will be randomly assigned to the isokinetic training group or the isotonic training group. 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.
Detailed Description
Our participants will include 40 patients within one month of stroke, 40 patients who received total hip replacement or total knee replacement two to four weeks before. The participants will be randomly assigned to the isokinetic training group or the isotonic training group. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Resistance Training, Stroke, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Isokinetic training
Arm Type
Experimental
Arm Description
Ten times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec
Arm Title
Isotonic training
Arm Type
Active Comparator
Arm Description
Ten times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee
Intervention Type
Device
Intervention Name(s)
Isokinetic strengthening exercise
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Isotonic strengthening exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak torque
Description
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
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Timed Up and Go test
Description
stand up from a chair, walk for 3 meters and go back and sit down
Time Frame
4 weeks
Title
Short Form 36 (SF-36) questionnaire
Description
Use the 36-item, patient-reported questionnaire to survey the self-perceived health status
Time Frame
4 weeks
Title
Oxford Hip/Knee Score
Description
symptoms score during daily activities
Time Frame
4 weeks
Title
The plasma concentration of hsCRP, and the level of substance P in saliva
Description
check by drawing blood and test
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan-Yang Cheng, MD, PhD
Phone
+886-4-23592525
Ext
3500
Email
rifampin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuan-Yang Cheng, MD, PhD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation
City
Taichung City
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuan-Yang Cheng, MD, PhD
Phone
+886423592525
Ext
3533
Email
rifampin@gmail.com
First Name & Middle Initial & Last Name & Degree
Yuan-Yang Cheng, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35757239
Citation
Cheng YY, Liu CC, Lin SY, Lee CH, Chang ST, Wang SP. Comparison of the Therapeutic Effects Between Isokinetic and Isotonic Strength Training in Patients After Total Knee Replacement: A Prospective, Randomized Controlled Trial. Orthop J Sports Med. 2022 Jun 21;10(6):23259671221105852. doi: 10.1177/23259671221105852. eCollection 2022 Jun.
Results Reference
derived
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The Effect of Isokinetic Strengthening Training
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