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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02938416
Other study ID # CF12251
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date December 2024

Study information

Verified date November 2023
Source Taichung Veterans General Hospital
Contact Yuan-Yang Cheng, MD, PhD
Phone +886-4-23592525
Email rifampin@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 70 Years
Eligibility 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 Design


Intervention

Device:
Isokinetic strengthening exercise
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.
Isotonic strengthening exercise
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.
Behavioral:
isometric strengthening exercise
home exercise education on isometric quadriceps strengthening on the day of out-patient appointment

Locations

Country Name City State
Taiwan Department of Physical Medicine and Rehabilitation Taichung City

Sponsors (1)

Lead Sponsor Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 4 weeks
Secondary Timed Up and Go test stand up from a chair, walk for 3 meters and go back and sit down 4 weeks
Secondary Short Form 36 (SF-36) questionnaire Use the 36-item, patient-reported questionnaire to survey the self-perceived health status 4 weeks
Secondary Oxford Hip/Knee Score symptoms score during daily activities 4 weeks
Secondary The plasma concentration of hsCRP, and the level of substance P in saliva check by drawing blood and test 4 weeks
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