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Impact of Different Exercise Programs on Knee OA

Primary Purpose

Osteoarthritis, Knee Osteoarthritis, Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise for Knee Osteoarthritis -(Land Based Treadmill or Community Walking)
Exercise for Knee Osteoarthritis -(LBPP supported low-load treadmill Walking)
Exercise for Knee Osteoarthritis - (Aquatic Walking)
Sponsored by
Shirley Ryan AbilityLab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee, Knee Osteoarthritis Exercise

Eligibility Criteria

50 Years - 75 Years (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. Clinical radiographic knee osteoarthritis: Symptoms of 2 or more knee pain, morning stiffness in the joint, crepitus on active movement, tenderness of the joint, bony enlargement of the joint, and lack of palpable warmth of the synovium Radiographic knee osteoarthritis: Kellgren-Lawrence score of 2 or greater using radiographs of the involved knee If the participant has had diagnostic radiographs within the previous 2 years at Shirley Ryan AbilityLab, we will use these previous radiographs to confirm diagnosis (these participants will complete a HIPAA authorization form so that we can access these images). If the participant has not had a diagnostic radiograph within the previous 2 years, the participant will complete a bilateral standing anteroposterior radiograph for the purpose of this study. These images are consistent with clinical care for diagnostic OA and minimally expose the individual to radiation (see attached form from radiology technician). All images taken as part of the study will be stored using the assigned study identifier, and therefore will not require any HIPAA authorization. Ability to walk without the use of aids (e.g., cane, walker) 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 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Control group: Standard of care land-based walking exercise

Intervention group 1: Lower-body positive-pressure supported low-load treadmill walking exercise

Intervention group 2: Aquatic Walking exercise

Arm Description

Participants enrolled in the land-based walking exercise program will complete a total of two community walking or normal treadmill (not LBPP) walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.

Participants enrolled in the Lower-body positive-pressure (LBPP) supported low-load treadmill walking exercise will complete a total of two walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each walking session will include 30-minute walking on a G-Trainer (AlterG Inc., Fremont, CA) under low-load walking conditions. Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.

Participants enrolled in the aquatic exercise program will complete a total of two aquatic walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each aquatic exercise program will include walking in the pool for 30 minutes at self-selected speeds under the guidance of an aquatic therapy instructor. Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.

Outcomes

Primary Outcome Measures

Change in Cartilage oligomeric matrix protein (COMP) serum concentration
Serum (blood) marker concentration
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Measured by the Pain Knee injury and Osteoarthritis Outcome Score subscale (KOOS subscales) as a comparison between different groups of the evolution of pain between Day 0 and Week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.

Secondary Outcome Measures

Strength measure of the quadriceps and hamstring muscles
The peak torque [measured in Newton meters (N·m)] achieved over the 4 repetitions measured using Biodex. To obtain a relative strength score for comparison between subjects, peak torque (N·m) will be divided by body weight (kg) to obtain a strength ratio (N·m/kg).
Function
Measured by the Function Knee injury and osteoarthritis score subscales (KOOS subscales) as a comparison between different groups of the evolution of function between Day 0 and Week 8.subscales) as a comparison between day 0, week 4, and week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Symptoms
Measured by the Symptoms Knee injury and Osteoarthritis Outcome Score subscales (KOOS subscales) as a comparison between different groups of the evolution of symptoms between Day 0 and Week 8.
Impact of Osteoarthritis on Quality of Life
Measured by the Quality of life Knee injury and Osteoarthritis Outcome Score subscales (KOOS subscales). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Quality of life measured using the EQ5D survey
Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
Change in Inflammatory cytokine (IL-6) concentration
Serum (blood) marker concentration
Change in Inflammatory cytokine (IL-1B) concentration
Serum (blood) marker concentration
Change in Inflammatory cytokine (TNF-A) concentration
Serum (blood) marker concentration
Questionnaire on Non-steroidal anti-inflammatory drugs (NSAID) use
This questionnaire will include questions on participants' use of any pain medications and their frequency/dosage. The response will be recorded during pre, interim and post-evaluation sessions and will be studied for any changes.
Analysis of cardiovascular parameters
Heart Rate measured at different time points
Change in Cardiometabolic (serum adiponectin) concentrations
Serum (blood) marker concentration

Full Information

First Posted
February 6, 2023
Last Updated
May 2, 2023
Sponsor
Shirley Ryan AbilityLab
Collaborators
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT05844124
Brief Title
Impact of Different Exercise Programs on Knee OA
Official Title
A Comparison of Impacts of Different Exercise Programs on Individuals With Knee Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
This study will examine and compare the changes in serum biomarkers, joint kinematics, and thigh muscle strength based on three different 8-week exercise protocols in individuals with knee pathology: Lower-body positive-pressure (LBPP) supported low-load treadmill walking and Aquatic exercise program and standard of care treadmill or community walking. Investigators hypothesize that both the 8-week exercise programs which aim to partially off-load the knee joint will be associated with a significant reduction in serum biological markers of joint disease (tissue turnover, cartilage degradation and inflammation) in response to the exercise. The serum biological markers will be directly correlated to participant reported knee pain. Both the LBPP-supported low-load and the aquatic exercise regimens will result in significant increases in thigh muscle strength about the degenerative knee which in-turn will result in diminished knee pain and enhanced joint function. Investigators aim to compare these two exercise programs to understand if benefits of one far exceeds the other as compared to standard of care treadmill or community walking.
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 the load is placed on the joint there is a 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. Aquatic therapy alleviates stress on joints and provides people with pain or arthritis a safe opportunity to engage in activity. Walking or running with weight support on a lower-body positive-pressure (LBPP) treadmill similar to aquatic exercise therapy 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 these methodologies (LBPP treadmill and aquatic therapy) alter the joint mechanics, the intra-articular biological effect on joint disease remains unknown. Diminished muscle strength is a common symptom associated with onset of knee osteoarthritis. Quadriceps muscle impairment in patients with knee OA is well documented in the literature. Muscle impairments in patients with OA are not limited to quadriceps but also involve hamstrings. Muscle strength, especially quadriceps, is a major determinant of both performance-based and self-reported physical function in subjects with knee OA. The evidence supports the benefit of exercise therapy (both land and aquatic), including global and targeted resistance training, in reducing pain and improving function in subjects with knee OA however research to date has been unable to quantify the disease-modifying effect of any form of exercise. A recent study from investigators laboratory in individuals with knee OA, walking at self-selected speed, found that at a single session of 45 minutes of 50% body weight (BW) walking on this treadmill leads to a significant decrease in knee joint pain, and reduced pathologic gait features. It also decreased the serum concentration of biomarkers of inflammation (IL-6 and IL-8), adipokines and cartilage tissue turnover (cartilage oligomeric matrix protein, COMP)24 compared to 100% full body weight walking. The benefits of both types of exercise are primarily as a result of the decreased effects of gravity with buoyancy or positive pressure being associated with decreased compressive and shear joint forces at the knee.25 To investigators' knowledge no prior study has performed a longitudinal clinical trial of either treatment in sedentary older individuals as a treatment for concurrent knee OA and CVD. The longitudinal use of such a treadmill may allow these individuals to safely engage in physical activity, reducing joint pain, improving function, and improving cardiovascular parameters. The present pilot study will establish the conditions and parameters for a future longer-term clinical trial that aims to compare of impacts of aquatic therapy exercise program and lower body positive pressure treadmill walking on biological markers of joint disease, joint kinematics and thigh muscle strength in individuals with knee pathology. The study investigators propose is a randomized controlled trial in individuals with mild to moderate knee OA (n=15 in each group), evaluating the symptomatic, biochemical, and biomechanical benefits of 3 walking exercise treatments: 1) LBPP treadmill walking 2) aquatic walking 3) standard of care land-based or community walking exercise for the same duration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
Keywords
Osteoarthritis, Knee, Knee Osteoarthritis Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The Principal Investigator will be masked to the patient treatment group assignment.
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group: Standard of care land-based walking exercise
Arm Type
Active Comparator
Arm Description
Participants enrolled in the land-based walking exercise program will complete a total of two community walking or normal treadmill (not LBPP) walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
Arm Title
Intervention group 1: Lower-body positive-pressure supported low-load treadmill walking exercise
Arm Type
Experimental
Arm Description
Participants enrolled in the Lower-body positive-pressure (LBPP) supported low-load treadmill walking exercise will complete a total of two walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each walking session will include 30-minute walking on a G-Trainer (AlterG Inc., Fremont, CA) under low-load walking conditions. Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
Arm Title
Intervention group 2: Aquatic Walking exercise
Arm Type
Experimental
Arm Description
Participants enrolled in the aquatic exercise program will complete a total of two aquatic walking exercise sessions per week for a total of eight consecutive weeks (i.e. 16 exercise sessions in all). Each aquatic exercise program will include walking in the pool for 30 minutes at self-selected speeds under the guidance of an aquatic therapy instructor. Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions at the beginning, interim, and end of the study where they will be walking on a standard-of care treadmill for 30 minutes with blood draws at 0 and 30 minutes (only during beginning and end session), kinematic measure of gait parameters, measures of different cardiovascular parameters and cardiometabolic markers followed by thigh muscle strength testing.
Intervention Type
Other
Intervention Name(s)
Exercise for Knee Osteoarthritis -(Land Based Treadmill or Community Walking)
Intervention Description
Standard-of-care Land-based walking exercise
Intervention Type
Other
Intervention Name(s)
Exercise for Knee Osteoarthritis -(LBPP supported low-load treadmill Walking)
Intervention Description
Lower-body positive-pressure (LBPP) supported low-load treadmill walking exercise
Intervention Type
Other
Intervention Name(s)
Exercise for Knee Osteoarthritis - (Aquatic Walking)
Intervention Description
Aquatic Walking exercise
Primary Outcome Measure Information:
Title
Change in Cartilage oligomeric matrix protein (COMP) serum concentration
Description
Serum (blood) marker concentration
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8
Title
Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Description
Measured by the Pain Knee injury and Osteoarthritis Outcome Score subscale (KOOS subscales) as a comparison between different groups of the evolution of pain between Day 0 and Week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8.
Secondary Outcome Measure Information:
Title
Strength measure of the quadriceps and hamstring muscles
Description
The peak torque [measured in Newton meters (N·m)] achieved over the 4 repetitions measured using Biodex. To obtain a relative strength score for comparison between subjects, peak torque (N·m) will be divided by body weight (kg) to obtain a strength ratio (N·m/kg).
Time Frame
Comparison between day 0, week 4, and week 8
Title
Function
Description
Measured by the Function Knee injury and osteoarthritis score subscales (KOOS subscales) as a comparison between different groups of the evolution of function between Day 0 and Week 8.subscales) as a comparison between day 0, week 4, and week 8. Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Title
Symptoms
Description
Measured by the Symptoms Knee injury and Osteoarthritis Outcome Score subscales (KOOS subscales) as a comparison between different groups of the evolution of symptoms between Day 0 and Week 8.
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Title
Impact of Osteoarthritis on Quality of Life
Description
Measured by the Quality of life Knee injury and Osteoarthritis Outcome Score subscales (KOOS subscales). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Title
Quality of life measured using the EQ5D survey
Description
Health-related quality of life will be measured using the EuroQol Five Dimensions (EQ-5D). The EQ-5D-5L is a valid extension of the 3-level questionnaire. It can be defined as a standardized non-disease specific value-based instrument to describe and value health-related quality of life. The instrument consists of two components: the EQ-5D descriptive system and the EQ visual analogue scale (EQ-VAS).The first part consists of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). The EQ-VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health.
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0, week 4, and week 8
Title
Change in Inflammatory cytokine (IL-6) concentration
Description
Serum (blood) marker concentration
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8
Title
Change in Inflammatory cytokine (IL-1B) concentration
Description
Serum (blood) marker concentration
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8
Title
Change in Inflammatory cytokine (TNF-A) concentration
Description
Serum (blood) marker concentration
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8
Title
Questionnaire on Non-steroidal anti-inflammatory drugs (NSAID) use
Description
This questionnaire will include questions on participants' use of any pain medications and their frequency/dosage. The response will be recorded during pre, interim and post-evaluation sessions and will be studied for any changes.
Time Frame
Comparison between day 0, week 4, and week 8
Title
Analysis of cardiovascular parameters
Description
Heart Rate measured at different time points
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8
Title
Change in Cardiometabolic (serum adiponectin) concentrations
Description
Serum (blood) marker concentration
Time Frame
Baseline, and 30 minutes of walking within session and also as a comparison between day 0 and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 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. Clinical radiographic knee osteoarthritis: Symptoms of 2 or more knee pain, morning stiffness in the joint, crepitus on active movement, tenderness of the joint, bony enlargement of the joint, and lack of palpable warmth of the synovium Radiographic knee osteoarthritis: Kellgren-Lawrence score of 2 or greater using radiographs of the involved knee If the participant has had diagnostic radiographs within the previous 2 years at Shirley Ryan AbilityLab, we will use these previous radiographs to confirm diagnosis (these participants will complete a HIPAA authorization form so that we can access these images). If the participant has not had a diagnostic radiograph within the previous 2 years, the participant will complete a bilateral standing anteroposterior radiograph for the purpose of this study. These images are consistent with clinical care for diagnostic OA and minimally expose the individual to radiation (see attached form from radiology technician). All images taken as part of the study will be stored using the assigned study identifier, and therefore will not require any HIPAA authorization. Ability to walk without the use of aids (e.g., cane, walker) 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
Sanchita Sen, MS
Phone
818-301-9213
Email
ssen@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
Sanchita Sen, MS
Phone
818-301-9213
Email
ssen@sralab.org
First Name & Middle Initial & Last Name & Degree
Vikram Darbhe, MS
Phone
3122387524
Email
vdarbhe@sralab.org
First Name & Middle Initial & Last Name & Degree
Prakash Jayabalan, MD, PhD
First Name & Middle Initial & Last Name & Degree
Vikram Darbhe, MS
First Name & Middle Initial & Last Name & Degree
Sanchita Sen, MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Different Exercise Programs on Knee OA

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