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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03431298
Other study ID # 06-M03-038
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2018
Est. completion date December 31, 2018

Study information

Verified date January 2018
Source National Yang Ming University
Contact Chuan-Hsin Yen, BS
Phone +886933301155
Email Yanlisa0728@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 exercise.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Aerobic exercise & movement control
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 exercise
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

Locations

Country Name City State
Taiwan Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 up to 6 months after intervention
Secondary 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. Baseline and up to 1 week after intervention
Secondary 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. Baseline and up to 1 week after intervention
Secondary Gait Cadence the number of steps per minute Baseline and up to 1 week after intervention
Secondary Walking speed the velocity of single step Baseline and up to 1 week after intervention
Secondary Single leg stance time the time of the stance phase of each foot Baseline and up to 1 week after intervention
Secondary 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 Baseline and up to 1 week after intervention
Secondary 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 Baseline and up to 1 week after intervention
Secondary 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 Baseline and up to 1 week after intervention
Secondary The Knee injury and Osteoarthritis Outcome Score A questionnaire to assess the patient's opinion about their knee and associated problems. Baseline and up to 1 week after intervention
Secondary Sort Form-12v2 Healthy Survey 12 question to measure functional health and well-being from the patient's point of view Baseline and 1, 3, 6 month after intervention
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