NCT00007241

Brief Summary

Studies have shown that isometric strengthening helps people with osteoarthritis of the knee. Isometric strengthening is muscle-strengthening exercise without movement, in which a person applies a force against a resistant object--for example, pushing against a brick wall. This study will test the effectiveness of a portable isometric exercise device for home use that guides a person through an exercise program using various forms of feedback. We will look at whether people exercising with the device achieve better outcomes (results) in pain, stiffness, strength, and functional measures compared to people who do not use the device or people exercising according to printed material from arthritis organizations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2001

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

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

First Submitted

Initial submission to the registry

December 16, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 18, 2000

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2001

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
Last Updated

January 4, 2007

Status Verified

February 1, 2003

First QC Date

December 16, 2000

Last Update Submit

January 2, 2007

Conditions

Osteoarthritis

Keywords

OsteoarthritisKneeOAIsometricExerciseStrengtheningJoint-related pain

Interventions

Isometric exerciseDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to give conformed consent.
  • Age \> 18.
  • Pain symptoms provoked by activity in the more symptomatic knee of between (and inclusive of) 3/10 and 8/10 on a verbal analog scale.

You may not qualify if:

  • Participation in a strengthening program of the knees in the past month.
  • Uncontrolled or functionally limiting cardiac disease.
  • Uncontrolled hypertension.
  • Severe peripheral neuropathy (i.e., insensate to the Simmes 5.07 monofilament).
  • Knee flexion contracture greater than 10 degrees.
  • Intra-articular steroids in the past 3 months, or hyaluronic acid in the last 9 months.
  • Poor health that would impair compliance or assessment.
  • Arthroscopy of either knee in the past six months.
  • Lateral instability of \> 15 degrees, or posterio-anterior instability of greater than 1 cm.
  • Knee pain due to pes anserine bursitis.
  • Active fibromyalgia.
  • Active alcohol or substance abuse.
  • Arthritis other than osteoarthritis in the more symptomatic knee.
  • Pregnancy.
  • History of cancer (other than skin cancer) not in remission.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Clinical Research Consultants, Inc.

Trumbull, Connecticut, 06611, United States

Location

Radiant Research, Inc.

Moorestown, New Jersey, 08057, United States

Location

Rochester Clinical Research, Inc.

Rochester, New York, 14609, United States

Location

Preventive Medical Technologies, Inc.

Philadelphia, Pennsylvania, 19104, United States

Location

Radiant Research, Inc.

Wyomissing, Pennsylvania, 19610, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Related Publications (1)

  • Goldman RJ, Reinbold KA, Iglarsh ZA, Neustadter LM, Oatis CA, Schumacher HR. Phase I design and evaluation of an isometric muscle reeducation device for knee osteoarthritis rehabilitation. J Rehabil Res Dev. 2003 Mar-Apr;40(2):95-107. doi: 10.1682/jrrd.2003.03.0095.

    PMID: 15077636BACKGROUND

MeSH Terms

Conditions

OsteoarthritisMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Kirk A. Reinbold, PhD

    Preventive Medical Technologies, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 16, 2000

First Posted

December 18, 2000

Study Start

September 1, 2001

Study Completion

July 1, 2002

Last Updated

January 4, 2007

Record last verified: 2003-02

Locations

US(6)