Impact of Different Exercise Programs on Knee OA

NCT05844124 | Active Not Recruiting DMC

• 1 other identifier: STU00215669
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis; Knee Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Keywords

Osteoarthritis; Knee; Knee Osteoarthritis Exercise

Outcome Measures

Primary Outcomes (1)

• Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)

  Measured by the Pain Knee injury and Osteoarthritis Outcome Score subscale (KOOS subscales) as a comparison between different groups of the evolution of pain between Day 0 and Week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8.

Secondary Outcomes (9)

• Function

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8

• Symptoms

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8

• Impact of Osteoarthritis on Quality of Life

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8

• Change in Inflammatory cytokine (IL-6) concentration

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8

• Change in Inflammatory cytokine (IL-1B) concentration

  Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8

Study Arms (3)

Control group: Standard of care land-based walking exercise

ACTIVE COMPARATOR

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.

Other: Exercise for Knee Osteoarthritis Recommendations (Control group)

Intervention group 1: Lower-body positive-pressure supported low-load treadmill walking exercise

EXPERIMENTAL

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.

Other: Exercise for Knee Osteoarthritis -(LBPP supported low-load treadmill Walking)

Intervention group 2: Aquatic Walking exercise

EXPERIMENTAL

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.

Other: Exercise for Knee Osteoarthritis - (Aquatic Walking)

Interventions

Exercise for Knee Osteoarthritis Recommendations (Control group) OTHER

Patients in this group will receive available exercise recommendations of 150 minutes of moderate intensity exercise per week (30 minutes per day).

Control group: Standard of care land-based walking exercise

Exercise for Knee Osteoarthritis -(LBPP supported low-load treadmill Walking) OTHER

Lower-body positive-pressure (LBPP) supported low-load treadmill walking exercise

Intervention group 1: Lower-body positive-pressure supported low-load treadmill walking exercise

Exercise for Knee Osteoarthritis - (Aquatic Walking) OTHER

Aquatic Walking exercise

Intervention group 2: Aquatic Walking exercise

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years
• Diagnosis of unilateral or bilateral knee osteoarthritis
• Clinical AND/OR radiographic knee osteoarthritis.
• Clinical radiographic knee osteoarthritis: Symptoms of 2 or more knee pain, morning stiffness in the joint, crepitus on active movement, tenderness of the joint, bony enlargement of the joint, and lack of palpable warmth of the synovium
• Radiographic knee osteoarthritis: Kellgren-Lawrence score of 2 or greater using radiographs of the involved knee
• If the participant has had diagnostic radiographs within the previous 2 years at Shirley Ryan AbilityLab, we will use these previous radiographs to confirm diagnosis (these participants will complete a HIPAA authorization form so that we can access these images).
• 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.
• Ability to walk without the use of aids (e.g., cane, walker)

You may not qualify if:

• Age \< 50 years
• History of lower extremity total joint arthroplasty
• Current cardiovascular disease or hypertension that is uncontrolled
• History of neurological disorder that effects lower extremity function (i.e., stroke, peripheral neuropathy, multiple sclerosis, Parkinson's disease)
• Current ankle or hip pain
• Currently pregnant for female participants
• Weight over 400 lbs (181.4 kg), height less than 4'8" (142 cm) or over 6'4" (193 cm), 18.5" (47 cm) hip width, or 58" (147 cm) hip circumference

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• Northwestern University: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Interventions

Exercise; Control Groups

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Prakash Jayabalan, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The Principal Investigator will be masked to the patient treatment group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Musculoskeletal Research

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 6, 2023
• Study Start: April 1, 2023
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)