- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000406
Effects of Strength Training on Knee Osteoarthritis
Effects of Strength Training on Knee Osteoarthritis (OA)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Several studies have confirmed that weak leg muscles are associated with osteoarthritis (OA) of the knee. Studies of body composition in these people have also shown that, despite being weaker, people with OA have significantly greater muscle mass than those without OA, suggesting that those with OA may have the potential to greatly increase their strength. However, research has not clearly shown whether exercises designed to improve leg strength will decrease the severity of pain or slow the progression of OA based on radiographic (x-ray) analysis. To understand the effects of leg strengthening exercise, we will perform a randomized clinical trial of lower extremity strength training using four subgroups of people: (1) OA with knee pain; (2) OA without knee pain; (3) no OA with knee pain; and (4) normal elderly with no OA or knee pain.
In each of the first three groups, we will determine whether people assigned to strength training have lower pain scores and/or slower progression of radiographic changes of OA over 30 months than controls who perform nonstrengthening exercises (i.e., range-of-motion exercises). We are including the fourth group to determine whether those with OA (groups 1 & 2) exhibit 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. We will also prospectively monitor changes in body composition and bone mass, quality of life, and symptoms of depression.
Study Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Locations
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Indiana
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Indianapolis, Indiana, United States, 46202
- National Institute for Fitness and Sport
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males and females 60 to 100 years of age
Exclusion Criteria:
- Knee joint replacement surgery
- Diabetes mellitus
- Uncontrollable hypertension
- Neuropathies of the lower extremity
- Poor mental cognition (i.e., inability to follow instructions)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alan Mikesky, PhD, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P60 AR20582 Substudy EEHSR3
- P60AR020582 (NIH)
- NIAMS-022
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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