Osteoarthritis, KneeNCT04139161
Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
A study testing Q-Factor Intervention in people with Osteoarthritis, Knee, run by The University of Tennessee, Knoxville at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Q-Factor Intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Biomechanics/Sports Medicine Lab
Knoxville, Tennessee, 37996
Tanner ThorsenZhang, MS, 865-974-2091, tthorsen@vols.utk.edu
Songning Zhang, PhD, 865-974-4716, szhang@utk.edu
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Q-Factor Intervention
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-Factor InterventionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Q-Factor Intervention | Experimental | 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. Receives: Procedure: Q-Factor Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Abduction Moment - Cycling
Change in Knee Extension Moment during cycling.
Measured: Baseline, 1 month, 2 month
Knee Abduction Moment - Gait
Change in Knee Extension Moment during gait.
Measured: Baseline, 1 month, 2 month
Secondary outcomes (4)
Visual Analog Pain
Self-Reported pain intensity during gait and cycling reported on a scale from 1-10 with higher scores reflecting more pain.
Measured: Immediately following exercise (walking and cycling).
Knee Extension Moment - Cycling
Change in Knee Extension Moment during cycling
Measured: Baseline, 1 month, 2 month
Knee Extension Moment - Gait
Change in Knee Extension Moment during Gait
Measured: Baseline, 1 month, 2 month
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.
Measured: Baseline, 1 month, 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start17 Dec 2019
- Primary completion31 May 2021 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Tennessee, Knoxville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanner Thorsen, The University of Tennessee, Knoxville
- Investigators
- Tanner Thorsen, MS, Principal investigator, University of Tennessee, Knoxville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139161
- Sponsor's protocol ID
- UTK IRB-19-05254-XP
- Status last verified
- Apr 2020
- First submitted
- 22 Oct 2019
- Last updated
- 7 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cycling Intervention on Symptoms of Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04139161
- Acronym / sponsor ID
- UTK IRB-19-05254-XP
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Tennessee, KnoxvilleUniversity, hospital or other
- Study start
- 17 Dec 2019 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Q-Factor Intervention | Experimental | Procedure: Q-Factor InterventionParticipants 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. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-Factor InterventionThe 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. | Procedure or surgery | Q-Factor Intervention |
Primary outcome
Knee Abduction Moment - Cycling
Time frame: Baseline, 1 month, 2 month
Change in Knee Extension Moment during cycling.
Knee Abduction Moment - Gait
Time frame: Baseline, 1 month, 2 month
Change in Knee Extension Moment during gait.
4 secondary outcomes
Visual Analog Pain
Time frame: Immediately following exercise (walking and cycling).
Knee Extension Moment - Cycling
Time frame: Baseline, 1 month, 2 month
Knee Extension Moment - Gait
Time frame: Baseline, 1 month, 2 month
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline, 1 month, 2 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanner Thorsen, MS principal investigator
University of Tennessee, Knoxville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q-Factor Intervention in people with Osteoarthritis, Knee, run by The University of Tennessee, Knoxville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tanner Thorsen, MS (865-974-2091, tthorsen@vols.utk.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Abduction Moment - Cycling (time frame: Baseline, 1 month, 2 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2020.