Exercise Programs for Knee Arthritis

Overseen By Sanchita Sen, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Joint arthroplasty, Cardiovascular disease, Neurological disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 16

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores different exercise routines to reduce knee pain from arthritis. It compares three methods: walking on a special treadmill that reduces knee pressure, walking in a pool, and standard walking exercises. The goal is to determine which method most effectively strengthens thigh muscles and reduces pain. Individuals with knee arthritis who can walk without aids might be suitable participants for this study. As an unphased trial, this study offers a unique opportunity to contribute to understanding effective exercise methods for knee arthritis.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these exercise programs are safe for individuals with knee arthritis?

Previous studies have shown that water-based exercise programs are safe and effective for people with knee osteoarthritis. Participants experienced less pain and improved joint movement without increased side effects, suggesting that walking in water is generally gentle on the body.

Research also shows that using a treadmill with low pressure on the body is a safe option. Studies have found it helps reduce knee pain and improves walking ability for those with knee osteoarthritis. This type of exercise is easy to use and doesn't cause major negative effects.

Both exercise programs have been tested in other settings and shown to be safe. They focus on reducing pain and improving movement, making them promising options for people with knee issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these exercise programs for knee osteoarthritis because they offer unique approaches compared to traditional land-based exercises. The aquatic walking exercise provides a low-impact option that reduces stress on the joints, making it ideal for those with severe pain or mobility issues. The lower-body positive-pressure (LBPP) supported treadmill walking uses advanced technology to reduce the load on the knees, potentially allowing for safer and more comfortable exercise. These innovative methods could offer effective alternatives for managing knee arthritis, especially for individuals who struggle with conventional exercise routines.

What evidence suggests that this trial's exercise programs could be effective for knee arthritis?

This trial will compare different exercise programs for knee arthritis. Studies have shown that exercising in water, as participants in the aquatic walking exercise group will do, effectively reduces pain and improves joint function for those with knee arthritis. It also strengthens knee muscles and eases walking. Similarly, research indicates that using a special treadmill that supports part of the body weight, as in the lower-body positive-pressure supported low-load treadmill walking exercise group, can reduce knee pain and improve walking by relieving pressure on the knees. Both water exercises and this treadmill approach show promise in increasing muscle strength and reducing discomfort in worn-out knee conditions. ^{1 4 6 7 8}

Who Is on the Research Team?

Prakash Jayabalan, MD, PhD

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

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.

Exclusion Criteria

You are currently experiencing pain in your ankle or hip.

Currently pregnant for female participants

Age < 50 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo one of three 8-week exercise programs: LBPP treadmill walking, aquatic walking, or standard of care land-based walking

8 weeks

16 exercise sessions, 3 evaluation sessions

Follow-up

Participants are monitored for changes in serum biomarkers, joint kinematics, and muscle strength

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention group 2: Aquatic Walking exercise Experimental Treatment 1 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 exercise Experimental Treatment 1 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 exercise Active Control 1 Intervention

Participants enrolled in the control group will be recommended national exercise recommendations pertianing to engaging in 150 minutes a week of moderate intensity exercise five times per week. 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.

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8955208/

Effects of Aquatic Exercises for Patients with Osteoarthritis For patients with osteoarthritis, aquatic-exercise-based interventions are effective for reducing pain and joint dysfunction and improving quality of life.

2. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-022-03069-6

Overall treatment effects of aquatic physical therapy in knee ... Aquatic physical therapy had a positive effect on the pain, physical function, knee extension muscle strength, and walking ability among people with knee ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3141607/

Systematic review and meta-analysis comparing land and ... Outcomes following aquatic exercise for adults with arthritis appear comparable to land based exercise. When people are unable to exercise on land, or find ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1063458417308695

Effects of high intensity resistance aquatic training on body ... Our findings show that high intensity aquatic resistance training decreases fat mass and improves walking speed in post-menopausal women with mild knee OA.

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/7/e093163

Effectiveness of exercise therapy in patients with knee ... Furthermore, 63.7% of the systematic reviews revealed that exercise therapy improved all outcomes. The number of intervention-related adverse events was small.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10942168/

a meta-analysis of randomized controlled trials - PMC Hydrotherapy is efficacious and safe for reducing pain and improving functional status in individuals with knee OA, without increasing the risk of adverse ...

7. bmj.com bmj.com/content/391/bmj-2025-085242

systematic review and network meta-analysis The safety outcome was reported in a small proportion of studies (40 studies, 18%), and no clear differences were observed between exercise ...

8. kjfm.or.kr kjfm.or.kr/journal/view.php?number=4773

Aquatic versus Land-Based Exercise for Knee Osteoarthritis Both aquatic and land-based exercises improved pain intensity, functional impairment, degree of handicap, and quality of life impairment caused by OA.