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Muscle Strengthening Device for Knee Osteoarthritis

This study has been completed.
Sponsor:
Information provided by:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:
NCT00007241
First received: December 16, 2000
Last updated: January 2, 2007
Last verified: February 2003
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Device: Isometric exercise
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Osteoarthritic Knee Isometric Exerciser for Home Use

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Estimated Enrollment: 92
Study Start Date: September 2001
Estimated Study Completion Date: July 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00007241

Locations
United States, Connecticut
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States, 06611
United States, New Jersey
Radiant Research, Inc.
Moorestown, New Jersey, United States, 08057
United States, New York
Rochester Clinical Research, Inc.
Rochester, New York, United States, 14609
United States, Pennsylvania
Preventive Medical Technologies, Inc.
Philadelphia, Pennsylvania, United States, 19104
Radiant Research, Inc.
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
Omega Medical Research
Warwick, Rhode Island, United States, 02886
Sponsors and Collaborators
Investigators
Principal Investigator: Kirk A. Reinbold, PhD Preventive Medical Technologies, Inc.
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00007241     History of Changes
Other Study ID Numbers: R44 AR45153, NIAMS-053
Study First Received: December 16, 2000
Last Updated: January 2, 2007
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Osteoarthritis
Knee
OA
Isometric
Exercise
Strengthening
Joint-related pain

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 27, 2014