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Exercise Programs for Knee Arthritis
N/A
Recruiting
Led By Prakash Jayabalan, MD, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Awards & highlights
Study Summary
This trial will compare 3 exercise protocols to see how they affect knee pain & joint function in people with knee pathology.
Who is the study for?
This trial is for individuals over 50 with knee osteoarthritis, able to walk unaided and have a Kellgren-Lawrence score of 2+ on knee radiographs. Excluded are those under 50, pregnant women, people with certain cardiovascular conditions or extreme body sizes, joint replacements, or neurological disorders affecting leg function.Check my eligibility
What is being tested?
The study compares three different 8-week exercise programs for knee osteoarthritis: standard treadmill/community walking, LBPP-supported low-load treadmill walking, and aquatic walking. It aims to assess their impact on serum biomarkers related to joint disease and thigh muscle strength.See study design
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects from these exercises may include muscle soreness, joint pain flare-ups during initial adaptation periods or if improperly performed.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Cartilage oligomeric matrix protein (COMP) serum concentration
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Secondary outcome measures
Analysis of cardiovascular parameters
Change in Cardiometabolic (serum adiponectin) concentrations
Change in Inflammatory cytokine (IL-1B) concentration
+8 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group 2: Aquatic Walking exerciseExperimental Treatment1 Intervention
Participants enrolled in the aquatic exercise program will complete a total of two aquatic walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each aquatic exercise program will include walking in the pool for 30 minutes at self-selected speeds under the guidance of an aquatic therapy instructor.
Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
Group II: Intervention group 1: Lower-body positive-pressure supported low-load treadmill walking exerciseExperimental Treatment1 Intervention
Participants enrolled in the Lower-body positive-pressure (LBPP) supported low-load treadmill walking exercise will complete a total of two walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each walking session will include 30-minute walking on a G-Trainer (AlterG Inc., Fremont, CA) under low-load walking conditions.
Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
Group III: Control group: Standard of care land-based walking exerciseActive Control1 Intervention
Participants enrolled in the land-based walking exercise program will complete a total of two community walking or normal treadmill (not LBPP) walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all).
Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
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Who is running the clinical trial?
Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,840 Total Patients Enrolled
Northwestern UniversityOTHER
1,585 Previous Clinical Trials
917,186 Total Patients Enrolled
Prakash Jayabalan, MD, PhDPrincipal InvestigatorShirley Ryan AbilityLab
3 Previous Clinical Trials
118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently experiencing pain in your ankle or hip.You have had surgery to replace a joint in your leg.You have been diagnosed with knee osteoarthritis in one or both knees.You have knee osteoarthritis, which means you experience at least two symptoms: knee pain, morning stiffness, joint noise, joint tenderness, joint swelling, and no warmth in the joint.You have knee osteoarthritis, which can be confirmed by clinical examination or X-ray images.You have a past or current neurological condition that affects the movement and function of your legs. This includes conditions like stroke, peripheral neuropathy, multiple sclerosis, and Parkinson's disease.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many people have been enrolled in this experiment so far?
"Indeed, according to clinicaltrials.gov this trial is actively recruiting its participants. The initial posting of the study was on March 1st 2023 and it has been most recently updated on May 2nd 2023. 45 patients are being sought from a single medical site for enrolment in the experiment."
Answered by AI
Is the age range for this clinical experiment limited to those over 35 years old?
"This medical trial is open to individuals aged 50 to 75. Meanwhile, there are 115 studies catering to those under 18 years old and 1082 investigations available for people above 65."
Answered by AI
Could I potentially qualify to participate in this research?
"This scientific study is seeking 45 volunteer candidates who are 50-75 years old and exhibit symptoms of osteoarthritis."
Answered by AI
Can individuals still join this clinical experiment?
"Based on the available data, this clinical trial is in a state of active recruitment. The study was initially posted to clinicaltrials.gov on March 1st 2023 and had its most recent update on May 2nd 2023."
Answered by AI
What are the desired outcomes of this examination?
"The primary purpose of this investigation, which will be assessed between baseline and 8 weeks later, is to evaluate the Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey). Secondary objectives encompass Functionality through KOOS subscales from day 0 up until week 8; Symptoms understood by means of KOOS's specified criteria over a similar period frame; as well as Impact of Osteoarthritis on Quality of Life determined by scores ranging from 0-100 with lower numbers denoting more severe issues."
Answered by AI
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