The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Aerobic exercise & movement control; Behavioral: 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
    • Sub-Investigator: Shuo-Suei Hung, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerobic exercise & movement control; The duration of intervention is 8 weeks.; Individualized functional movement control training is 60 min/week; Aerobic exercise is 60 min/week	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
Active Comparator: Aerobic exercise; The duration of intervention is 8 weeks.; Frequency: 2 times/ week; Duration: 60min/ time	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Gait Cadence	the number of steps per minute	Baseline and up to 1 week after intervention
Walking speed	the velocity of single step	Baseline and up to 1 week after intervention
Single leg stance time	the time of the stance phase of each foot	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	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	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	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.	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	Baseline and 1, 3, 6 month after intervention

Collaborators and Investigators

• Sponsor: National Yang Ming University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: January 28, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): August 28, 2018
• Last Update Submitted That Met QC Criteria: August 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Exercise; Physical activity; Knee osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 06-M03-038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No