NCT03431298

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

August 28, 2018

Status Verified

January 1, 2018

Enrollment Period

10 months

First QC Date

January 28, 2018

Last Update Submit

August 26, 2018

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritisPhysical activityExercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Partial foot pressure as a percentage of body weight

    Baseline and up to 1 week after intervention

  • Partial foot area as a percentage of body mass index

    Baseline and up to 1 week after intervention

  • Gait Cadence

    Baseline and up to 1 week after intervention

  • Walking speed

    Baseline and up to 1 week after intervention

  • Single leg stance time

    Baseline and up to 1 week after intervention

  • +5 more secondary outcomes

Study Arms (2)

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

Behavioral: Aerobic exercise & movement control

Aerobic exercise

ACTIVE COMPARATOR

The duration of intervention is 8 weeks. * Frequency: 2 times/ week * Duration: 60min/ time

Behavioral: Aerobic exercise

Interventions

Aerobic exercise & movement controlBEHAVIORAL

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 & movement control
Aerobic exerciseBEHAVIORAL

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

Aerobic exercise

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with walking disability
  • Cannot complete 8 weeks intervention program
  • Received arthroscopy or other surgery before 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

New Taipei City, Taiwan

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Wen-Yin Chen, PhD

    National Yang-Ming University The Department of Physical Therapy and Assistive Technology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chuan-Hsin Yen, BS

CONTACT

+886933301155Yanlisa0728@gmail.com

Wen-Yin Chen, PhD

CONTACT

wychen@ym.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2018

First Posted

February 13, 2018

Study Start

March 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

August 28, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)