The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Aerobic exercise & movement control
Aerobic exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Knee Osteoarthritis focused on measuring Knee osteoarthritis, Physical activity, Exercise
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with walking disability
- Cannot complete 8 weeks intervention program
- Received arthroscopy or other surgery before 6 months
Sites / Locations
- Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Aerobic exercise & movement control
Aerobic exercise
Arm Description
The duration of intervention is 8 weeks. Individualized functional movement control training is 60 min/week Aerobic exercise is 60 min/week
The duration of intervention is 8 weeks. Frequency: 2 times/ week Duration: 60min/ time
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
Gait Cadence
the number of steps per minute
Walking speed
the velocity of single step
Single leg stance time
the time of the stance phase of each foot
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
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
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
The Knee injury and Osteoarthritis Outcome Score
A questionnaire to assess the patient's opinion about their knee and associated problems.
Sort Form-12v2 Healthy Survey
12 question to measure functional health and well-being from the patient's point of view
Full Information
NCT ID
NCT03431298
First Posted
January 28, 2018
Last Updated
August 26, 2018
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT03431298
Brief Title
The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis
Official Title
The Benefit of Increasing Physical Activity and Functional Movement Control for Patients With Stage II or III Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
December 31, 2018 (Anticipated)
Study Completion Date
December 31, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee osteoarthritis, Physical activity, Exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aerobic exercise & movement control
Arm Type
Experimental
Arm Description
The duration of intervention is 8 weeks.
Individualized functional movement control training is 60 min/week
Aerobic exercise is 60 min/week
Arm Title
Aerobic exercise
Arm Type
Active Comparator
Arm Description
The duration of intervention is 8 weeks.
Frequency: 2 times/ week
Duration: 60min/ time
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise & movement control
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Aerobic exercise
Intervention Description
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
Primary Outcome Measure Information:
Title
reaching proportions of the level of health enhancing physical activity
Description
the recommended level of health enhancing physical activity is at least 150 min of moderate intensity physical activity per week
Time Frame
up to 6 months after intervention
Secondary Outcome Measure Information:
Title
Partial foot pressure as a percentage of body weight
Description
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.
Time Frame
Baseline and up to 1 week after intervention
Title
Partial foot area as a percentage of body mass index
Description
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.
Time Frame
Baseline and up to 1 week after intervention
Title
Gait Cadence
Description
the number of steps per minute
Time Frame
Baseline and up to 1 week after intervention
Title
Walking speed
Description
the velocity of single step
Time Frame
Baseline and up to 1 week after intervention
Title
Single leg stance time
Description
the time of the stance phase of each foot
Time Frame
Baseline and up to 1 week after intervention
Title
Step length
Description
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
Time Frame
Baseline and up to 1 week after intervention
Title
Step width
Description
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
Time Frame
Baseline and up to 1 week after intervention
Title
Axis angle
Description
the angle formed by the medial tangent of the foot and the line from the second/third toe to the center of the heel
Time Frame
Baseline and up to 1 week after intervention
Title
The Knee injury and Osteoarthritis Outcome Score
Description
A questionnaire to assess the patient's opinion about their knee and associated problems.
Time Frame
Baseline and up to 1 week after intervention
Title
Sort Form-12v2 Healthy Survey
Description
12 question to measure functional health and well-being from the patient's point of view
Time Frame
Baseline and 1, 3, 6 month after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients with walking disability
Cannot complete 8 weeks intervention program
Received arthroscopy or other surgery before 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chuan-Hsin Yen, BS
Phone
+886933301155
Email
Yanlisa0728@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen-Yin Chen, PhD
Email
wychen@ym.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Yin Chen, PhD
Organizational Affiliation
National Yang-Ming University The Department of Physical Therapy and Assistive Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
City
New Taipei City
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shuo-Suei Hung, PhD
Phone
+886970333582
Email
hung_ortho@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Shuo-Suei Hung, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis
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