The Benefit of Functional Movement Control for Patients With Knee Osteoarthritis

August 26, 2018 updated by: National Yang Ming University

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 6 months after intervention

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Partial foot pressure as a percentage of body weight
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and up to 1 week after intervention
the number of steps per minute
Baseline and up to 1 week after intervention
Walking speed
Time Frame: Baseline and up to 1 week after intervention
the velocity of single step
Baseline and up to 1 week after intervention
Single leg stance time
Time Frame: Baseline and up to 1 week after intervention
the time of the stance phase of each foot
Baseline and up to 1 week after intervention
Step length
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and up to 1 week after intervention
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
Time Frame: Baseline and 1, 3, 6 month after intervention
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Yang Ming University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 28, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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