search
Back to results

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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anti-Gravity Treadmill
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Knee Osteoarthritis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shirley Ryan AbilityLabRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

100% body weight walking

50% body weight walking

Arm Description

Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 100% full body weight loading

Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 50% full body weight loading

Outcomes

Primary Outcome Measures

Change in Cartilage oligomeric matrix protein serum concentration
Serum (blood) marker concentration
Change in Knee Joint Pain
Numeric pain rating scale (NPRS). Higher scores on this scale indicate higher pain

Secondary Outcome Measures

Change in Inflammatory cytokine (IL-6, IL-1B and TNF-A) concentration
Serum (blood) marker concentration

Full Information

First Posted
December 11, 2020
Last Updated
February 6, 2021
Sponsor
Shirley Ryan AbilityLab
search

1. Study Identification

Unique Protocol Identification Number
NCT04747444
Brief Title
Positive Pressure Treadmill Walking for Individuals With Knee Pathology
Acronym
LBPPKNEEOA
Official Title
The Effects of Anti-Gravity Treadmill Walking In Individuals With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shirley Ryan AbilityLab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 100% full body weight loading
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
100% body weight walking
Arm Type
Other
Arm Description
Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 100% full body weight loading
Arm Title
50% body weight walking
Arm Type
Other
Arm Description
Individuals with knee osteoarthritis will walk 45 minutes on a treadmill at 50% full body weight loading
Intervention Type
Other
Intervention Name(s)
Anti-Gravity Treadmill
Intervention Description
Treadmill in which the body weight percent placed on the lower extremities can be controlled
Primary Outcome Measure Information:
Title
Change in Cartilage oligomeric matrix protein serum concentration
Description
Serum (blood) marker concentration
Time Frame
baseline, and 45 minutes of walking
Title
Change in Knee Joint Pain
Description
Numeric pain rating scale (NPRS). Higher scores on this scale indicate higher pain
Time Frame
baseline, and 45 minutes of walking
Secondary Outcome Measure Information:
Title
Change in Inflammatory cytokine (IL-6, IL-1B and TNF-A) concentration
Description
Serum (blood) marker concentration
Time Frame
baseline, and 45 minutes of walking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prakash Jayabalan, MD, PhD
Phone
3122387326
Email
pjayabalan@sralab.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prakash Jayabalan, MD, PhD
Organizational Affiliation
Shirley Ryan AbilityLab
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shirley Ryan AbilityLab
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prakash Jayabalan
Phone
312-238-7326
Email
pjayabalan@sralab.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Positive Pressure Treadmill Walking for Individuals With Knee Pathology

We'll reach out to this number within 24 hrs