Positive Pressure Treadmill Walking for Individuals With Knee Pathology (LBPPKNEEOA)

The Effects of Anti-Gravity Treadmill Walking In Individuals With Knee Osteoarthritis

Our goal is to compare the serum biomarker changes of joint disease that occur in response to partially off-loaded (50%) walking exercise to regular (100%) walking exercise while on a Lower Body Positive Pressure (LBPP) treadmill. Secondly we are determining the relationship between changes in the concentration of these serum biomarkers and participant reported knee pain while walking on a LBPP treadmill.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Anti-Gravity Treadmill

Detailed Description

The morphology and composition of healthy mature articular cartilage is optimized to its primary function of load transfer and distribution. In the osteoarthritic state however, homeostasis of the knee joint is significantly altered, such that as load is placed on the joint there is progressive worsening of cartilage damage over time. Altered joint mechanics and intra-articular biological processes are thought to play pivotal roles in the initial breakdown and potentiation of cartilage damage which is the hallmark finding in knee OA leading to knee pain. Walking or running with weight support on a lower-body positive-pressure (LBPP) treadmill is a novel training and rehabilitation modality for individuals with lower extremity pathologies due to its ability to limit pain. This treadmill provides a controlled off-loading of the lower extremities with significant benefit being shown after 12 weeks of training in overweight individuals with knee OA on knee pain, function and muscle strength. Although this methodology alters the joint mechanics, the intra-articular biological effect on joint disease remains unknown.

A recent study from our laboratory compared walking exercise on a regular treadmill at a defined speed with and without rest breaks in 27 participants with knee OA and demonstrated that one-hour rest breaks had significant benefits. This conclusion was based on reduction in knee joint contact force and decreased levels of a serum marker commonly associated with cartilage degradation (cartilage oligomeric matrix protein, COMP) at 45 minutes of walking. This investigation assessed patterns of walking, but the impact of varying knee joint contact force, such as by walking on a LBPP treadmill on the biological profiles of joint disease is not known. The present study will establish the conditions and parameters for a future longer-term clinical trial that aims to individualize the amount of joint loading during LBPP treadmill training in participants with knee OA based on their biomarker profile.

Objective 1: Compare the serum biomarker changes of joint disease that occur in response to partially off-loaded (50%) walking exercise to regular (100%) walking exercise while on a LBPP treadmill.

Objective 2: Determine the relationship between changes in the concentration of these serum biomarkers and participant reported knee pain while walking on a LBPP treadmill.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan Abilitylab
      • Contact: Prakash Jayabalan; Phone Number: 312-238-7326; Email: pjayabalan@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age > 50 years
• Diagnosis of unilateral or bilateral knee osteoarthritis
• Clinical AND/OR radiographic knee osteoarthritis.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 100% body weight walking; Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 100% full body weight loading	Other: Anti-Gravity Treadmill; Treadmill in which the body weight percent placed on the lower extremities can be controlled
Other: 50% body weight walking; Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 50% full body weight loading	Other: Anti-Gravity Treadmill; Treadmill in which the body weight percent placed on the lower extremities can be controlled

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Cartilage oligomeric matrix protein serum concentration	Serum (blood) marker concentration	baseline, and 45 minutes of walking
Change in Knee Joint Pain	Numeric pain rating scale (NPRS). Higher scores on this scale indicate higher pain	baseline, and 45 minutes of walking

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Inflammatory cytokine (IL-6, IL-1B and TNF-A) concentration	Serum (blood) marker concentration	baseline, and 45 minutes of walking

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab
• Investigators: Principal Investigator: Prakash Jayabalan, MD, PhD, Shirley Ryan Abilitylab

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): September 1, 2021

Study Registration Dates

• First Submitted: December 11, 2020
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 00209531

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No