Exercise Programs for Knee Arthritis

Recruiting in Palo Alto (17 mi)

Overseen byPrakash Jayabalan, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study will examine and compare the changes in serum biomarkers, joint kinematics, and thigh muscle strength based on three different 8-week exercise protocols in individuals with knee pathology: Lower-body positive-pressure (LBPP) supported low-load treadmill walking and Aquatic exercise program and standard of care treadmill or community walking. Investigators hypothesize that both the 8-week exercise programs which aim to partially off-load the knee joint will be associated with a significant reduction in serum biological markers of joint disease (tissue turnover, cartilage degradation and inflammation) in response to the exercise. The serum biological markers will be directly correlated to participant reported knee pain. Both the LBPP-supported low-load and the aquatic exercise regimens will result in significant increases in thigh muscle strength about the degenerative knee which in-turn will result in diminished knee pain and enhanced joint function. Investigators aim to compare these two exercise programs to understand if benefits of one far exceeds the other as compared to standard of care treadmill or community walking.

Eligibility Criteria

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.

Inclusion Criteria

Age ≥ 50 years

If the participant has not had a diagnostic radiograph within the previous 2 years, the participant will complete a bilateral standing anteroposterior radiograph for the purpose of this study. These images are consistent with clinical care for diagnostic OA and minimally expose the individual to radiation (see attached form from radiology technician). All images taken as part of the study will be stored using the assigned study identifier, and therefore will not require any HIPAA authorization

You have been diagnosed with knee osteoarthritis in one or both knees.

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Exclusion Criteria

You are currently experiencing pain in your ankle or hip.

Currently pregnant for female participants

Age < 50 years

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Treatment Details

Interventions

Exercise for Knee Osteoarthritis - (Aquatic Walking) (Behavioural Intervention)
Exercise for Knee Osteoarthritis -(Land Based Treadmill or Community Walking) (Behavioural Intervention)
Exercise for Knee Osteoarthritis -(LBPP supported low-load treadmill Walking) (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

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.