Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Q-Factor Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee
Eligibility Criteria
Inclusion Criteria:
- Men and Women between the ages of 50 and 75 years old.
- Diagnosed with medial compartment tibiofemoral osteoarthritis in one of their knees.
- Be able to walk unaided for at least 25 consecutive minutes.
- Present with knee pain for at least 6 months occurring on a majority of the days in the month, or on most days (more than or equal to 4 of 7 days in a week) in one or both knees for at least 4 months.
- Osteophytes on knee x-rays.
- Grade 2 or higher out of a maximum of 4 on a modified Kellgren/Lawrence grade on the knee radiograph.
Exclusion Criteria:
- Initial Visual Analog Scale pain scores greater than 7.
- Diagnosed osteoarthritis of ankles, hips, or symptomatic osteoarthritis of the spine.
- Arthroplasty of any other lower extremity joint.
- BMI value greater than 40 kg/m2.
- Any major lower extremity injury in the past 6 months.
- Systemic Inflammatory Arthritis.
- Systemic Pain Conditions.
- Neurological Conditions that impact gait or cycling.
- Pregnant or Nursing Women.
- Major cardiovascular disease with an exercise limitation prescribed by a physician.
- Steroid injection at the knee within the previous 3 months.
Sites / Locations
- Biomechanics/Sports Medicine LabRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Q-Factor Intervention
Arm Description
Participants will progress through three increasing Q-Factors for each cycling workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated.
Outcomes
Primary Outcome Measures
Knee Abduction Moment - Cycling
Change in Knee Extension Moment during cycling.
Knee Abduction Moment - Gait
Change in Knee Extension Moment during gait.
Secondary Outcome Measures
Visual Analog Pain
Self-Reported pain intensity during gait and cycling reported on a scale from 1-10 with higher scores reflecting more pain.
Knee Extension Moment - Cycling
Change in Knee Extension Moment during cycling
Knee Extension Moment - Gait
Change in Knee Extension Moment during Gait
Knee Injury and Osteoarthritis Outcome Score
Change in Knee Injury and Osteoarthritis Outcome Score reported on a scale from 0 to 100, with 0 representing extreme problems and 100 representing no problems.
Full Information
NCT ID
NCT04139161
First Posted
October 22, 2019
Last Updated
April 6, 2020
Sponsor
The University of Tennessee, Knoxville
1. Study Identification
Unique Protocol Identification Number
NCT04139161
Brief Title
Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
Official Title
Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 17, 2019 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
May 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Tennessee, Knoxville
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
This study is designed to determine the effect of a cycling training program which modulates frontal and sagittal plane knee joint loading with graded increases of Q-Factor and cycling workrate in persons with symptomatic knee osteoarthritis.
Detailed Description
The knee joint is one of the most common joints affected by osteoarthritis, and knee osteoarthritis is primarily observed in the medial compartment. This is in part attributable to the increased load experienced by the medial compartment during level walking. Patients with symptomatic knee osteoarthritis exhibit altered gait mechanics; namely a reduced loading response knee extension moment and an increased internal knee abduction moment. As a surrogate measure for medial compartment joint loading, loading response knee abduction moment in level walking has been shown to increase with the severity of knee osteoarthritis.
Recent gait modification research has shown that increased step-width decreases peak Knee abduction moment for persons with knee osteoarthritis. The inter-pedal width of a bicycle or cycle ergometer, known as Q-Factor, is analogous in cycling to step-width in gait. In contrast to gait, increased Q-Factor has been shown to increase the knee abduction moment during stationary cycling. Modulating sagittal and frontal plane loading of the knee in a graded manner during cycling may promote healthy adaptation to muscle weakness and pain. This adaptation may be manifest through restoration of altered knee joint biomechanics (knee extension moment, knee abduction moment), which, in turn, may also provide benefit to gait mechanics.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Q-Factor Intervention
Arm Type
Experimental
Arm Description
Participants will progress through three increasing Q-Factors for each cycling workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated.
Intervention Type
Procedure
Intervention Name(s)
Q-Factor Intervention
Intervention Description
The intervention period will consist of 12 training sessions across four consecutive weeks, with three training sessions held per week. If pain is not increased or reduced and Rating of Perceived Exertion is ≤12, the participant will progress to the next bout. If pain is increased from the pre-bout pain score, participants will repeat the bout, at the same workrate and Q-Factor settings. Following this fashion, participants will progress through three increasing Q-Factors for each given workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated. For each training session, participants will complete bouts of cycling until 1) the maximum number of bouts (4 bouts) has been accomplished, 2) self-reported Rating of Perceived Exertion >12, indicating a transition to moderate physical activity, or 3) self-reported pain >5.
Primary Outcome Measure Information:
Title
Knee Abduction Moment - Cycling
Description
Change in Knee Extension Moment during cycling.
Time Frame
Baseline, 1 month, 2 month
Title
Knee Abduction Moment - Gait
Description
Change in Knee Extension Moment during gait.
Time Frame
Baseline, 1 month, 2 month
Secondary Outcome Measure Information:
Title
Visual Analog Pain
Description
Self-Reported pain intensity during gait and cycling reported on a scale from 1-10 with higher scores reflecting more pain.
Time Frame
Immediately following exercise (walking and cycling).
Title
Knee Extension Moment - Cycling
Description
Change in Knee Extension Moment during cycling
Time Frame
Baseline, 1 month, 2 month
Title
Knee Extension Moment - Gait
Description
Change in Knee Extension Moment during Gait
Time Frame
Baseline, 1 month, 2 month
Title
Knee Injury and Osteoarthritis Outcome Score
Description
Change in Knee Injury and Osteoarthritis Outcome Score reported on a scale from 0 to 100, with 0 representing extreme problems and 100 representing no problems.
Time Frame
Baseline, 1 month, 2 month
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:
Men and Women between the ages of 50 and 75 years old.
Diagnosed with medial compartment tibiofemoral osteoarthritis in one of their knees.
Be able to walk unaided for at least 25 consecutive minutes.
Present with knee pain for at least 6 months occurring on a majority of the days in the month, or on most days (more than or equal to 4 of 7 days in a week) in one or both knees for at least 4 months.
Osteophytes on knee x-rays.
Grade 2 or higher out of a maximum of 4 on a modified Kellgren/Lawrence grade on the knee radiograph.
Exclusion Criteria:
Initial Visual Analog Scale pain scores greater than 7.
Diagnosed osteoarthritis of ankles, hips, or symptomatic osteoarthritis of the spine.
Arthroplasty of any other lower extremity joint.
BMI value greater than 40 kg/m2.
Any major lower extremity injury in the past 6 months.
Systemic Inflammatory Arthritis.
Systemic Pain Conditions.
Neurological Conditions that impact gait or cycling.
Pregnant or Nursing Women.
Major cardiovascular disease with an exercise limitation prescribed by a physician.
Steroid injection at the knee within the previous 3 months.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanner Thorsen, MS
Phone
865-974-2091
Email
tthorsen@vols.utk.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Songning Zhang, PhD
Phone
865-974-4716
Email
szhang@utk.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanner Thorsen, MS
Organizational Affiliation
University of Tennessee, Knoxville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biomechanics/Sports Medicine Lab
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37996
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tanner ThorsenZhang, MS
Phone
865-974-2091
Email
tthorsen@vols.utk.edu
First Name & Middle Initial & Last Name & Degree
Songning Zhang, PhD
Phone
865-974-4716
Email
szhang@utk.edu
First Name & Middle Initial & Last Name & Degree
Tanner Thorsen, MS
First Name & Middle Initial & Last Name & Degree
Songning Zhang, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
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Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
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