Resistance TrainingNCT02938416
The Effect of Isokinetic Strengthening Training
A study testing Isokinetic strengthening exercise, Isotonic strengthening exercise and isometric strengthening exercise in people with Resistance Training and Stroke, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Resistance Training, Stroke, Arthroplasty, Replacement, Hip
- What is being tested?
- Isokinetic strengthening exercise, Isotonic strengthening exercise and isometric strengthening exercise
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- within one month of acute stroke
- receive total hip/knee replacement within two to four weeks before
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Physical Medicine and Rehabilitation
Taichung, 40705
Yuan-Yang Cheng, MD, PhD, +886423592525 ext. 3533, rifampin@gmail.com
Yuan-Yang Cheng, MD, PhD
About this study
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
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.
Read the 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
- Conditions
- Resistance Training, Stroke, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Being tested
- Isokinetic strengthening exercise, Isotonic strengthening exercise, isometric strengthening exercise
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isokinetic strengthening exerciseDevice
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 exerciseDevice
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.
isometric strengthening exerciseBehavioural
home exercise education on isometric quadriceps strengthening on the day of out-patient appointment
| Study group | Role | What they receive |
|---|---|---|
| Isokinetic training | Experimental | Ten times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec Receives: Device: Isokinetic strengthening exercise |
| Isotonic training | Active comparator | Ten times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee Receives: Device: Isotonic strengthening exercise |
| isometric training | Placebo comparator | home exercise education on isometric quadriceps strengthening on the day of out-patient appointment Receives: Behavioral: isometric strengthening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 weeks
Secondary outcomes (4)
Timed Up and Go test
stand up from a chair, walk for 3 meters and go back and sit down
Measured: 4 weeks
Short Form 36 (SF-36) questionnaire
Use the 36-item, patient-reported questionnaire to survey the self-perceived health status
Measured: 4 weeks
Oxford Hip/Knee Score
symptoms score during daily activities
Measured: 4 weeks
The plasma concentration of hsCRP, and the level of substance P in saliva
check by drawing blood and test
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistance TrainingStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Yang Cheng, Taichung Veterans General Hospital
- Investigators
- Yuan-Yang Cheng, MD, PhD, Principal investigator, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938416
- Sponsor's protocol ID
- CF12251
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2016
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Cheng YY, Chen CH, Wang SP. Isokinetic training of lower extremity during the early stage promote functional restoration in elder patients with disability after Total knee replacement (TKR) - a randomized control trial. BMC Geriatr. 2024 Feb 19;24(1):173. doi: 10.1186/s12877-024-04778-9.
PubMed 38373934Cheng 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.
PubMed 35757239
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02938416
- Acronym / sponsor ID
- CF12251
- Conditions
- Resistance Training, Stroke, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Isokinetic training | Experimental | Device: Isokinetic strengthening exerciseTen times, three sets of isokinetic strengthening exercise using 30 degree/sec and 120 degree/sec |
| Isotonic training | Active comparator | Device: Isotonic strengthening exerciseTen times, three sets of isotonic strengthening exercise using consistent resistance of 60% of 1-repetition maximum of hip or knee |
| isometric training | Placebo comparator | Behavioral: isometric strengthening exercisehome exercise education on isometric quadriceps strengthening on the day of out-patient appointment |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- within one month of acute stroke
- receive total hip/knee replacement within two to four weeks before
Key exclusion criteria (7 listed)
- cannot perform from sitting to standing
- Body Mass Index > 30
- Lower limbs fracture history
- Diabetic polyneuropathy
- Cardiopulmonary diseases that impede exercise prescription
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isokinetic strengthening exerciseIsokinetic 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. | Device | Isokinetic training |
| Isotonic strengthening exerciseIsotonic 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. | Device | Isotonic training |
| isometric strengthening exercisehome exercise education on isometric quadriceps strengthening on the day of out-patient appointment | Behavioural | isometric training |
Primary outcome
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
4 secondary outcomes
Timed Up and Go test
Time frame: 4 weeks
Short Form 36 (SF-36) questionnaire
Time frame: 4 weeks
Oxford Hip/Knee Score
Time frame: 4 weeks
The plasma concentration of hsCRP, and the level of substance P in saliva
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Derived from this study: PubMed 38373934Cheng YY, Chen CH, Wang SP. Isokinetic training of lower extremity during the early stage promote functional restoration in elder patients with disability after Total knee replacement (TKR) - a randomized control trial. BMC Geriatr. 2024 Feb 19;24(1):173. doi: 10.1186/s12877-024-04778-9.
- Derived from this study: PubMed 35757239Cheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuan-Yang Cheng, MD, PhD principal investigator
Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isokinetic strengthening exercise, Isotonic strengthening exercise and isometric strengthening exercise in people with Resistance Training and Stroke, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuan-Yang Cheng, MD, PhD (+886-4-23592525 ext. 3500, rifampin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02938416, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.