Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

Effects of Retro Walking Exercise Using Lower Body Positive Pressure on Knee Pain and Physical Function in People With Knee Osteoarthritis

The goal of this clinical trial is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on knee pain, physical function, and quadriceps muscle strength in people with mild to moderate knee OA. The secondary aim is to compare effects of retro walking exercise versus forward walking using lower body positive pressure on mobility function, balance, and self-reported health outcomes in people with mild to moderate knee OA. The main questions it aims to answer are:

• Does retro walking exercise improve knee pain, physical function and Quadriceps muscle strength compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?
• Does retro walking exercise improve Mobility function, balance, and self-reported health outcomes compared to forward walking exercise using lower body positive pressure in people with mild to moderate knee osteoarthritis?

Participants will walk (retro versus forward) on a lower body positive pressure treadmill.

If there is a comparison group: Researchers will compare [retro walking compares to forward walking] to see if [improve in knee pain, physical function, and quadriceps muscles strength]

Study Overview

• Status: Recruiting
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Other: Exercise

• Study Type: Interventional
• Enrollment (Estimated): 26
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sattam M Almutairi, Ph.D; Phone Number: +966505102644; Email: A.sattam@qu.edu.sa

Study Locations

• Saudi Arabia
  • Buraidah, Saudi Arabia
    • Recruiting
    • Medical City in Qassim University
    • Contact: Sattam Almutairi; Phone Number: 0505102644
  • Almuledia
    • Buraydah, Almuledia, Saudi Arabia, 52373
      • Recruiting
      • Qassim University Medical City
      • Contact: Sattam M Almutairi; Phone Number: +966505102644; Email: A.sattam@qu.edu.sa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Mild to moderate knee osteoarthritis
• Edge bigger or equal 40 years
• Knee pain reported by participants in the past 30 days
• One or both knees osteoarthritis graded with Kellgren & Lawrence grade 1 - 3

Exclusion Criteria:

• If they didn't meet the inclusion criteria
• History of hip, knee or ankle injury or surgery within the last year
• Kellgren & Lawrence grade > 3 of severe knee OA
• Diagnosed with rheumatoid arthritis
• History of knee injection with any medicine that reduce pain within the last year
• History of other medical condition that would disturb normal walking function
• Receive physical therapy in the last three months
• Pregnant
• Other conditions that are Contra indication to lower body positive pressure.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Participants will walk in retro walking exercise on lower body positive pressure treadmill.	Other: Exercise; Participants will stand on lower body positive pressure treadmill and participate in walking exercise.; Other Names: Walking exercise
Other: Control; Participants will walk in forward walking exercise on lower body positive pressure treadmill.	Other: Exercise; Participants will stand on lower body positive pressure treadmill and participate in walking exercise.; Other Names: Walking exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric pain rating scale	The NPRS is an 11-point scale with "0" representing "no pain" and "10" representing "most imaginable pain" used to assess pain intensity.	Change from baseline pain at 6 weeks
Knee injury and osteoarthritis outcome score (KOOS)	The KOOS is a self-reported, knee-specific questionnaire that is aimed to measure knee pain, symptoms, and level of disability during the last week.	Change from baseline pain, symptoms, and level of disability at 6 weeks.
Thigh muscle strength test	A Biodex isokinetic dynamometer (Model 4Pro) connected to a computer will be used to assess bilateral knee's flexor and extensor isometric muscle strength.	Change from baseline thigh muscle strength at 6 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Five times sit to stand test	The FTSST is used to assess lower extremity strength and balance and is an indicator of postural control.	Change from baseline balance at 6 weeks.
3-M Backward Walk Test	Patients will be instructed to walk backwards when the assessor says "go" and stop when the participant pass the end line colored tape. The participant will be allowed to look back.	Change from baseline backward walking at six weeks.
Timed up and go test	The TUG assesses functional mobility by assessing an individual's ability to stand up, walk 3 meters at a comfortable pace, turn 180 degrees, walk back 3 meters, and sit down	Change from baseline Functional mobility at six weeks.
4 square step test	The test is designed to assess dynamic balance and coordination.	Change from baseline dynamic balance and coordination at six weeks
Functional reach test	FRT used to assess participant's stability and balance by measuring the maximum distance participant can reach forward while standing in fixed position.	Change from baseline static balance at six weeks
10-Meter Walk Test	The 10-MWT evaluates walking speed over a short duration with or without an assistive device.	Change from baseline walking speed at six weeks
6 minute walk test	6MWT assesses the distance walked over 6 minutes as a test of aerobic capacity and endurance.	Change from baseline aerobic capacity and endurance at six week
Medical Outcomes Study Short Form 12 (SF-12)	It is a health survey that evaluates health related quality of life in a clinical practice and research purpose	Change from baseline quality of life at six weeks
Patient Health Questionnaire -9	PHQ-9 is an instrument to evaluate depression symptoms among different populations.	Change from baseline depression at six week
Rapid Assessment of Physical Activity	RAPA is a 9-items, self-reported questionnaire measures the levels of physical activity of adult older than 50 years.	Change from baseline physical activity at six week

Collaborators and Investigators

• Sponsor: Qassim University

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: October 15, 2022
• First Submitted That Met QC Criteria: October 15, 2022
• First Posted (Actual): October 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

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: 22-07-07

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