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Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Exercise
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Qassim university medical cityRecruiting
  • Medical City in Qassim UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental

Control

Arm Description

Participants will walk in retro walking exercise on lower body positive pressure treadmill.

Participants will walk in forward walking exercise on lower body positive pressure treadmill.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Five times sit to stand test
The FTSST is used to assess lower extremity strength and balance and is an indicator of postural control.
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.
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
4 square step test
The test is designed to assess dynamic balance and coordination.
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.
10-Meter Walk Test
The 10-MWT evaluates walking speed over a short duration with or without an assistive device.
6 minute walk test
6MWT assesses the distance walked over 6 minutes as a test of aerobic capacity and endurance.
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
Patient Health Questionnaire -9
PHQ-9 is an instrument to evaluate depression symptoms among different populations.
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.

Full Information

First Posted
October 15, 2022
Last Updated
June 19, 2023
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT05585099
Brief Title
Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis
Official Title
Effects of Retro Walking Exercise Using Lower Body Positive Pressure on Knee Pain and Physical Function in People With Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2023 (Actual)
Primary Completion Date
November 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University

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
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]

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
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
Participants will walk in retro walking exercise on lower body positive pressure treadmill.
Arm Title
Control
Arm Type
Other
Arm Description
Participants will walk in forward walking exercise on lower body positive pressure treadmill.
Intervention Type
Other
Intervention Name(s)
Exercise
Other Intervention Name(s)
Walking exercise
Intervention Description
Participants will stand on lower body positive pressure treadmill and participate in walking exercise.
Primary Outcome Measure Information:
Title
Numeric pain rating scale
Description
The NPRS is an 11-point scale with "0" representing "no pain" and "10" representing "most imaginable pain" used to assess pain intensity.
Time Frame
Change from baseline pain at 6 weeks
Title
Knee injury and osteoarthritis outcome score (KOOS)
Description
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.
Time Frame
Change from baseline pain, symptoms, and level of disability at 6 weeks.
Title
Thigh muscle strength test
Description
A Biodex isokinetic dynamometer (Model 4Pro) connected to a computer will be used to assess bilateral knee's flexor and extensor isometric muscle strength.
Time Frame
Change from baseline thigh muscle strength at 6 weeks.
Secondary Outcome Measure Information:
Title
Five times sit to stand test
Description
The FTSST is used to assess lower extremity strength and balance and is an indicator of postural control.
Time Frame
Change from baseline balance at 6 weeks.
Title
3-M Backward Walk Test
Description
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.
Time Frame
Change from baseline backward walking at six weeks.
Title
Timed up and go test
Description
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
Time Frame
Change from baseline Functional mobility at six weeks.
Title
4 square step test
Description
The test is designed to assess dynamic balance and coordination.
Time Frame
Change from baseline dynamic balance and coordination at six weeks
Title
Functional reach test
Description
FRT used to assess participant's stability and balance by measuring the maximum distance participant can reach forward while standing in fixed position.
Time Frame
Change from baseline static balance at six weeks
Title
10-Meter Walk Test
Description
The 10-MWT evaluates walking speed over a short duration with or without an assistive device.
Time Frame
Change from baseline walking speed at six weeks
Title
6 minute walk test
Description
6MWT assesses the distance walked over 6 minutes as a test of aerobic capacity and endurance.
Time Frame
Change from baseline aerobic capacity and endurance at six week
Title
Medical Outcomes Study Short Form 12 (SF-12)
Description
It is a health survey that evaluates health related quality of life in a clinical practice and research purpose
Time Frame
Change from baseline quality of life at six weeks
Title
Patient Health Questionnaire -9
Description
PHQ-9 is an instrument to evaluate depression symptoms among different populations.
Time Frame
Change from baseline depression at six week
Title
Rapid Assessment of Physical Activity
Description
RAPA is a 9-items, self-reported questionnaire measures the levels of physical activity of adult older than 50 years.
Time Frame
Change from baseline physical activity at six week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sattam M Almutairi, Ph.D
Phone
+966505102644
Email
A.sattam@qu.edu.sa
Facility Information:
Facility Name
Qassim university medical city
City
Buraydah
State/Province
Almuledia
ZIP/Postal Code
52373
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sattam M Almutairi
Phone
+966505102644
Email
A.sattam@qu.edu.sa
Facility Name
Medical City in Qassim University
City
Buraidah
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sattam Almutairi
Phone
0505102644

12. IPD Sharing Statement

Plan to Share IPD
No

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Effects of Lower Body Positive Pressure in People With Knee Osteoarthritis

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