Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585099
• Other study ID #: 22-07-07
• Status: Recruiting
• Phase: N/A
• Start date: June 15, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: June 2023
• Source: Qassim University
• Contact: Sattam M Almutairi, Ph.D
• Phone: +966505102644
• Email: A.sattam[@]qu.edu.sa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Exercise
Participants will stand on lower body positive pressure treadmill and participate in walking exercise.

Locations

Country	Name	City	State
Saudi Arabia	Medical City in Qassim University	Buraidah
Saudi Arabia	Qassim university medical city	Buraydah	Almuledia

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	4 square step test	The test is designed to assess dynamic balance and coordination.	Change from baseline dynamic balance and coordination at six weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Patient Health Questionnaire -9	PHQ-9 is an instrument to evaluate depression symptoms among different populations.	Change from baseline depression at six week
Secondary	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