Muscle Strengthening Device for Knee Osteoarthritis

Osteoarthritic Knee Isometric Exerciser for Home Use

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Device: Isometric exercise

Detailed Description

Previous studies have shown that isometric strengthening is beneficial in managing osteoarthritis of the knee. This type of exercise can decrease joint-related pain and stiffness while increasing strength and functional measures. However, individuals rarely adhere to isometric exercise for any lengthy period of time because there has not been a way to measure applied force and performance over time in the home setting. In addition, this type of exercise has often been described as "boring." We believe that being able to monitor one's progress is essential in maintaining adherence to an isometric exercise program. This study will examine the effectiveness of a portable isometric exercise device for home use that guides the user through an exercise protocol by means of various forms of feedback.

We hypothesize that individuals exercising with the device will achieve better outcomes in pain, stiffness, strength, and functional measures than a control group or a group exercising according to printed material from arthritis advocacy groups. We will randomly assign study participants meeting eligibility criteria to the exercise device group, exercise according to printed material group, or control group. We will conduct measures in all groups during a clinic visit at baseline, 2, 4, 6, and 8 weeks. As subjects in the exercise device group strengthen their leg muscles, a physical therapist will likely need to adjust upward the target force for different leg positions during every clinic visit, 2 weeks apart.

• Study Type: Interventional
• Enrollment: 92
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Trumbull, Connecticut, United States, 06611
      • Clinical Research Consultants, Inc.
  • New Jersey
    • Moorestown, New Jersey, United States, 08057
      • Radiant Research, Inc.
  • New York
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Preventive Medical Technologies, Inc.
    • Wyomissing, Pennsylvania, United States, 19610
      • Radiant Research, Inc.
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Omega Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Symptomatic spine, hip, ankle, or foot disease other than osteoarthritis that would interfere with assessment of the knee.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Collaborators and Investigators

• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Kirk A. Reinbold, PhD, Preventive Medical Technologies, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Study Completion: July 1, 2002

Study Registration Dates

• First Submitted: December 16, 2000
• First Submitted That Met QC Criteria: December 16, 2000
• First Posted (Estimate): December 18, 2000

Study Record Updates

• Last Update Posted (Estimate): January 4, 2007
• Last Update Submitted That Met QC Criteria: January 2, 2007
• Last Verified: February 1, 2003

More Information

Terms related to this study

• Keywords: Exercise; Osteoarthritis; Knee; OA; Strengthening; Isometric; Joint-related pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: R44AR045153 (U.S. NIH Grant/Contract); NIAMS-053