Knee OsteoarthritisNCT03431298
The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis
A study testing Aerobic exercise in people with Knee Osteoarthritis, run by National Yang Ming Chiao Tung University at 1 site in Taiwan.
Trial summary
The study purpose is to explore the effect of functional movement control for patients who have stage II or III degenerative knee joint disease and also physical inactive. Half of patients will receive aerobic exercise and functional movement control training in combination, while the other will simply receive aerobic… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Aerobic exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2018to 31 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant who was diagnosed has knee osteoarthritis
- Above 40 years old
- Participant who didn't achieve at least 150 min moderate intensity physical activity level per week
Who cannot join
- Patients with walking disability
- Cannot complete 8 weeks intervention program
- Received arthroscopy or other surgery before 6 months
Trial locations and contacts
1 site in 1 country.
Wen-Yin Chen, PhD contact
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City
Shuo-Suei Hung, PhD, +886970333582, hung_ortho@yahoo.com.tw
Shuo-Suei Hung, PhD
About this study
Official title: The Benefit of Increasing Physical Activity and Functional Movement Control for Patients With Stage II or III Knee Osteoarthritis
The study purpose is to explore the effect of functional movement control for patients who have stage II or III degenerative knee joint disease and also physical inactive. Half of patients will receive aerobic exercise and functional movement control training in combination, while the other will simply receive aerobic exercise.
Read the detailed description
Physical inactivity, which is a common phenomenon among patients with degenerative knee joint disease has been proved a predictor of increased symptoms and poor general health. However, changing the lifestyle of people with this disease who is physical inactive is still a problem which has not been solved. Knee pain may act as barrier to engage in physical activity and can influence patient's movement performance.
The different effectiveness between the aerobic exercise and functional movement control training.
Aerobic exercise has been proved could improve knee pain for the patients with degenerative knee joint disease.
The functional movement control training could improve knee alignment during walking and other functional activities to increase patient's movement awareness.
- Conditions
- Knee Osteoarthritis
- Being tested
- Aerobic exercise & movement control, Aerobic exercise
- Keywords
- Knee osteoarthritis, Physical activity, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exercise & movement controlBehavioural
The aerobic exercise content is no different between the experimental group and the active comparator group.
The movement control is individual training which divided into fourths progressing sessions.
- First, lumbo-pelvic and hip dynamic direction control.
- Second, trunk muscle groups, hip muscle groups and thigh muscle groups extensibility control.
- Third, trunk muscle groups and hip muscle groups through range control.
- Fourth, functional movement control training
Aerobic exerciseBehavioural
The aerobic exercise will organized in groups. Each group has 6-8 persons. The exercise form is fixed at each time.
The description of exercise form is as below:
- 10 min Warm up
- 40 min Aerobic exercise (which focus on lower extremity muscle strengthening and increasing muscle endurance)
- 10 min Cool down
| Study group | Role | What they receive |
|---|---|---|
| Aerobic exercise & movement control | Experimental | The duration of intervention is 8 weeks.
* Individualized functional movement control training is 60 min/week
* Aerobic exercise is 60 min/week Receives: Behavioral: Aerobic exercise & movement control |
| Aerobic exercise | Active comparator | The duration of intervention is 8 weeks.
* Frequency: 2 times/ week
* Duration: 60min/ time Receives: Behavioral: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
reaching proportions of the level of health enhancing physical activity
the recommended level of health enhancing physical activity is at least 150 min of moderate intensity physical activity per week
Measured: up to 6 months after intervention
Secondary outcomes (10)
Partial foot pressure as a percentage of body weight
The area footprinted during gait was divided into 6 parts according to the average foot areas of subject. Then, the partial foot pressure as a percentage of body weight was calculated as the average value during the stance phase of each step in each part as a percentage of the body weight.
Measured: Baseline and up to 1 week after intervention
Partial foot area as a percentage of body mass index
The area footprinted during gait was divided into 6 parts. The partial foot area as a percentage of body mass index was calculated as the average value during the stance phase of each step in each part as a percentage of the body mass index.
Measured: Baseline and up to 1 week after intervention
Gait Cadence
the number of steps per minute
Measured: Baseline and up to 1 week after intervention
Walking speed
the velocity of single step
Measured: Baseline and up to 1 week after intervention
Single leg stance time
the time of the stance phase of each foot
Measured: Baseline and up to 1 week after intervention
Step length
the distance between the first point of contact of a limb with the ground and the first point of contact of the limb on the opposite side
Measured: Baseline and up to 1 week after intervention
Step width
the distance between the centre of the first heel contact and the following one calculated perpendicularly to the direction of the horizontal axis drawn between the feet
Measured: Baseline and up to 1 week after intervention
Axis angle
the angle formed by the medial tangent of the foot and the line from the second/third toe to the center of the heel
Measured: Baseline and up to 1 week after intervention
The Knee injury and Osteoarthritis Outcome Score
A questionnaire to assess the patient's opinion about their knee and associated problems.
Measured: Baseline and up to 1 week after intervention
Sort Form-12v2 Healthy Survey
12 question to measure functional health and well-being from the patient's point of view
Measured: Baseline and 1, 3, 6 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study start1 Mar 2018
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Yin Chen, PhD, Principal investigator, National Yang-Ming University The Department of Physical Therapy and Assistive Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03431298
- Sponsor's protocol ID
- 06-M03-038
- Status last verified
- Jan 2018
- First submitted
- 28 Jan 2018
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Benefit of Increasing Physical Activity and Functional Movement Control for Patients With Stage II or III Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03431298
- Acronym / sponsor ID
- 06-M03-038
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis, Physical activity, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 13 Feb 2018 (actual)
- 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.
The study purpose is to explore the effect of functional movement control for patients who have stage II or III degenerative knee joint disease and also physical inactive. Half of patients will receive aerobic exercise and functional movement control training in combination, while the other will simply receive aerobic exercise.
Detailed description
Physical inactivity, which is a common phenomenon among patients with degenerative knee joint disease has been proved a predictor of increased symptoms and poor general health. However, changing the lifestyle of people with this disease who is physical inactive is still a problem which has not been solved. Knee pain may act as barrier to engage in physical activity and can influence patient's movement performance.
The different effectiveness between the aerobic exercise and functional movement control training.
Aerobic exercise has been proved could improve knee pain for the patients with degenerative knee joint disease.
The functional movement control training could improve knee alignment during walking and other functional activities to increase patient's movement awareness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aerobic exercise & movement control | Experimental | Behavioral: Aerobic exercise & movement controlThe duration of intervention is 8 weeks. * Individualized functional movement control training is 60 min/week * Aerobic exercise is 60 min/week |
| Aerobic exercise | Active comparator | Behavioral: Aerobic exerciseThe duration of intervention is 8 weeks. * Frequency: 2 times/ week * Duration: 60min/ time |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant who was diagnosed has knee osteoarthritis
- Above 40 years old
- Participant who didn't achieve at least 150 min moderate intensity physical activity level per week
Key exclusion criteria (3 listed)
- Patients with walking disability
- Cannot complete 8 weeks intervention program
- Received arthroscopy or other surgery before 6 months
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 |
|---|---|---|
| Aerobic exercise & movement controlThe aerobic exercise content is no different between the experimental group and the active comparator group. The movement control is individual training which divided into fourths progressing sessions. * First, lumbo-pelvic and hip dynamic direction control. * Second, trunk muscle groups, hip muscle groups and thigh muscle groups extensibility control. * Third, trunk muscle groups and hip muscle groups through range control. * Fourth, functional movement control training | Behavioural | Aerobic exercise & movement control |
| Aerobic exerciseThe aerobic exercise will organized in groups. Each group has 6-8 persons. The exercise form is fixed at each time. The description of exercise form is as below: * 10 min Warm up * 40 min Aerobic exercise (which focus on lower extremity muscle strengthening and increasing muscle endurance) * 10 min Cool down | Behavioural | Aerobic exercise |
Primary outcome
reaching proportions of the level of health enhancing physical activity
Time frame: up to 6 months after intervention
the recommended level of health enhancing physical activity is at least 150 min of moderate intensity physical activity per week
10 secondary outcomes
Partial foot pressure as a percentage of body weight
Time frame: Baseline and up to 1 week after intervention
Partial foot area as a percentage of body mass index
Time frame: Baseline and up to 1 week after intervention
Gait Cadence
Time frame: Baseline and up to 1 week after intervention
Walking speed
Time frame: Baseline and up to 1 week after intervention
Single leg stance time
Time frame: Baseline and up to 1 week after intervention
Step length
Time frame: Baseline and up to 1 week after intervention
Step width
Time frame: Baseline and up to 1 week after intervention
Axis angle
Time frame: Baseline and up to 1 week after intervention
The Knee injury and Osteoarthritis Outcome Score
Time frame: Baseline and up to 1 week after intervention
Sort Form-12v2 Healthy Survey
Time frame: Baseline and 1, 3, 6 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- 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.
Wen-Yin Chen, PhD contact
Wen-Yin Chen, PhD principal investigator
National Yang-Ming University The Department of Physical Therapy and Assistive Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Knee Osteoarthritis, run by National Yang Ming Chiao Tung University 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 3 inclusion and 3 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 28 Aug 2018. 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. 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 Chuan-Hsin Yen, BS (+886933301155, Yanlisa0728@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reaching proportions of the level of health enhancing physical activity (time frame: up to 6 months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2018; AzTrials last refreshed its copy on 7 Nov 2026.