NCT00000406

Brief Summary

To understand the effects of leg strengthening exercise, we will study the effects of strength training of the legs in four groups of people: (1) osteoarthritis (OA) with knee pain; (2) OA without knee pain; (3) no OA but elderly with knee pain; and (4) normal elderly with no OA or knee pain. In each of the first three groups, we will look at whether people who do strength training have less pain and/or slower progression of x-ray signs of OA over 30 months than people who perform nonstrengthening, range-of-motion exercises. We are including the fourth group to find out whether people with OA (groups 1 \& 2) have the same response to strength training as healthy elderly people, and whether those with knee pain (groups 1 \& 3) have the same response to training as those without joint pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 1977

Longer than P75 for phase_2

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

September 1, 1977

Completed
22.2 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

29.2 years

First QC Date

November 3, 1999

Last Update Submit

April 29, 2013

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis (OA)KneeRadiographic OAStrength trainingPhysical therapyExerciseBody compositionStriated muscleDepressionRadiographic OA with knee painRadiographic OA without knee painKnee pain without radiographic OANormal elderly (no radiographic OA, no knee pain)

Interventions

Progressive resistance exercisePROCEDURE

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males and females 60 to 100 years of age

You may not qualify if:

  • Knee joint replacement surgery
  • Diabetes mellitus
  • Uncontrollable hypertension
  • Neuropathies of the lower extremity
  • Poor mental cognition (i.e., inability to follow instructions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute for Fitness and Sport

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • Mikesky AE, Mazzuca SA, Brandt KD, Perkins SM, Damush T, Lane KA. Effects of strength training on the incidence and progression of knee osteoarthritis. Arthritis Rheum. 2006 Oct 15;55(5):690-9. doi: 10.1002/art.22245.

    PMID: 17013851RESULT

MeSH Terms

Conditions

Osteoarthritis, KneeOsteoarthritisMotor ActivityDepression

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehaviorBehavioral Symptoms

Study Officials

  • Alan Mikesky, PhD

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

September 1, 1977

Primary Completion

November 1, 2006

Study Completion

November 1, 2006

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

US(1)