NCT00265447

Brief Summary

The purpose of this project is to establish evidence to support specific, targeted exercise and rehabilitation recommendations for people over 50 with osteoarthritis of the knee.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at below P25 for phase_3 knee-osteoarthritis

Timeline
Completed

Started Dec 2005

Longer than P75 for phase_3 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2005

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

5.6 years

First QC Date

December 13, 2005

Last Update Submit

September 26, 2016

Conditions

Keywords

knee osteoarthritisexerciseaerobic exercisestrengthening exerciseexercise prescriptionrehabilitationphysical disabilityphysical functionphysical activityphysical fitness

Outcome Measures

Primary Outcomes (2)

  • WOMAC Pain scale

    baseline, 3 months, and 6 months

  • WOMAC physical function scale, muscle performance,flexibility, aerobic capacity, self-reported health status

    baseline, 3 months, 6 months

Secondary Outcomes (1)

  • AIMS2

    baseline, 3 months, 6 months

Study Arms (3)

Strength training

ACTIVE COMPARATOR

3 months of strength training

Behavioral: Strength training

Aerobic conditioning

ACTIVE COMPARATOR

3 months of aerobic conditioning

Behavioral: Aerobic conditioning

Delayed exercise

OTHER

delayed exercise control group

Behavioral: Delayed exercise

Interventions

3 months of strength training

Strength training

3 months of aerobic conditioning

Aerobic conditioning

delayed exercise control group

Delayed exercise

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • community-dwelling, physician diagnosed osteoarthritis of the knee, willingness to exercise regularly, willingness to perform 3 testing sessions over a 6-month period, ability to exercise safely at a moderate level of intensity, knee osteoarthritis by clinical criteria,
  • WOMAC Scores as follows:
  • PAIN:"mild" pain on 2 items or "moderate" pain on 1 item; PHYSICAL FUNCTION: "mild" difficulty in 4 items or "moderate" difficulty in 2 items -

You may not qualify if:

  • age\<50,inability to exercise and ambulate independently, physical limitation secondary to a condition that is not modifiable by exercise (e.g., active cancer), knee replacement (past or scheduled), total hip joint replacement less than 6 months ago, current participation in regular conditioning exercise, participation in another research study,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65211, United States

Location

MeSH Terms

Conditions

Osteoarthritis, KneeMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marian A Minor, PhD

    Department of Physical Therapy, School of Health Professions, University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2005

First Posted

December 14, 2005

Study Start

December 1, 2005

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 28, 2016

Record last verified: 2016-09

Locations