Positive Pressure Treadmill Walking for Individuals With Knee Pathology

NCT04747444 | Unknown

• 1 other identifier: 00209531
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

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

  baseline, and 45 minutes of walking

Study Arms (2)

100% body weight walking

OTHER

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

Other: Anti-Gravity Treadmill

50% body weight walking

OTHER

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

Other: Anti-Gravity Treadmill

Interventions

Anti-Gravity Treadmill OTHER

Treadmill in which the body weight percent placed on the lower extremities can be controlled

100% body weight walking; 50% body weight walking

Eligibility Criteria

• Age: 50 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.

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

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

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

Study Officials

• Prakash Jayabalan, MD, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prakash Jayabalan, MD, PhD

CONTACT

3122387326; pjayabalan@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

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

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: February 10, 2021
• Study Start: June 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)