OsteoarthritisNCT05857605
The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee OA
A study testing Exercise for Knee Osteoarthritis and Compact seated elliptical exercise machine- Cubii JR-1 in people with Osteoarthritis and Knee Osteoarthritis, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
Exercise is considered the most effective, non-drug treatment for reducing pain and improving movement in patients with osteoarthritis. Diminished muscle strength is a common symptom associated with the onset of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee Osteoarthritis, Arthritis
- What is being tested?
- Exercise for Knee Osteoarthritis and Compact seated elliptical exercise machine- Cubii JR-1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2023to 31 Mar 2024
- 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
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Shirley Ryan AbilityLab
Chicago, Illinois, 60611
Juliana Couri, 818-301-9213, jcouri02@sralab.org
Vikram Darbhe, 312-238-7535, vdarbhe@sralab.org
About this study
Official title: The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee Osteoarthritis.
Exercise is considered the most effective, non-drug treatment for reducing pain and improving movement in patients with osteoarthritis. Diminished muscle strength is a common symptom associated with the onset of knee osteoarthritis. The evidence supports the benefit of exercise therapy, 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. The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis.
Read the detailed description
Objective: The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis. This includes a range of motion of the knee and ankle, level of pain as measured using a standard questionnaire, muscle strength as well as satisfaction scores with this device. This study will contain two groups: A control group receiving a standard physical therapy exercise program instruction, and a treatment group that will receive standard physical therapy exercise program instruction in conjunction with a home exercise program using a seated compact elliptical machine (Cubii JR1).
Hypothesis: The hypothesis is that subjects with knee osteoarthritis who use the at-home seated compact elliptical trainer for a minimum of 30-minutes per day in conjunction with standard physical therapy program instruction will have a greater reduction in pain, increased range of motion at the knee, and ankle joint, increase in quality of life and greater quadriceps and hamstring muscle strength than those who receive just the standard physical therapy program instruction.
- Conditions
- Osteoarthritis, Knee Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Being tested
- Exercise for Knee Osteoarthritis, Compact seated elliptical exercise machine- Cubii JR-1
- Keywords
- Osteoarthritis, Knee, Knee Osteoarthritis Exercise
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise for Knee OsteoarthritisOther
Standard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis.
Compact seated elliptical exercise machine- Cubii JR-1Device
Compact seated elliptical machine exerice program in conjunction with standard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis.
| Study group | Role | What they receive |
|---|---|---|
| Standard Physical Therapy exercise instructions for Knee Osteoarthritis | Active comparator | Participants enrolled in the control group will be provided standard physical therapy exercise instruction based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis. During their first visit, the participants will meet the trained research staff to trial a series of therapeutic exercises for medial knee OA. They will be provided a handout with pictures of these exercises after they have demonstrated the ability to complete them at the initial visit. The participants will then complete this program on their own for 8 weeks; performing the exercises 3 times per week.
Apart from these home-based exercise sessions participants in this group will complete 3 separate evaluation sessions onsite at the beginning, interim, and end of the study where they will complete a series of functional tests and fill standard questionnaires evaluating their pain, symptoms and knee function followed by thigh muscle strength testing. Receives: Other: Exercise for Knee Osteoarthritis |
| Standard Physical Therapy exercise instructions for Knee Osteoarthritis + seated elliptical device | Experimental | Participants in the intervention group will be provided physical therapy (PT) exercise instruction based on Arthritis Foundation guidelines for physical activity specific to individuals with knee OA. Participants will be provided a handout with pictures of these exercises after they have demonstrated the ability to complete them at the initial visit. They will then complete this program on their own for 8 weeks; performing the exercises 3 times per week. This group will also receive a compact seated elliptical device which they will be expected to use for a min of 30 min for 5 days per week in conjunction with PT exercise instruction.
Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions on-site at the beginning, interim, and end of the study where they will complete a series of functional tests and fill standard questionnaires evaluating their pain, symptoms, and knee function followed by thigh muscle strength testing. Receives: Other: Exercise for Knee Osteoarthritis; Device: Compact seated elliptical exercise machine- Cubii JR-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 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.
Measured: Comparison between day 0, week 4, and week 8
Secondary outcomes (13)
Change in Function
Measured by the Function 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.
Measured: Comparison between day 0, week 4, and week 8
Change in 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.
Measured: Comparison between day 0, week 4, and week 8
Impact of Osteoarthritis on Quality of Life (Change in KOOS subscale is assessed)
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.
Measured: Comparison between day 0, week 4, and week 8
Quality of life measured using the EQ5D survey (Change is assessed)
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.
Measured: Comparison between day 0, week 4, and week 8
Change in 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).
Measured: Comparison between day 0, week 4, and week 8
Change in walking speed
Measured using the 10 m walk test: participants are timed as they walk 10m and this walking speed is calculated using (speed = distance/time) in m/s
Measured: Comparison between day 0, week 4, and week 8
Change in walking endurance
Measured using 6min walk test: participant walks for 6 minutes and the distance (m) walked is measured. If needed, the number of breaks taken is noted.
Measured: Comparison between day 0, week 4, and week 8
Stair negotiation (Change is assessed)
Participants are timed (seconds) as they ascend and descend a flight of stairs.
Measured: Comparison between day 0, week 4, and week 8
5 times sit-to-stand (Change is assessed)
Participants are timed (seconds) as they stand from a seated position in a chair and sit back down 5 times.
Measured: Comparison between day 0, week 4, and week 8
Participant Exercise Log
Self-reported compliance with exercise program
Measured: 8 weeks
Patient satisfaction
Survey administered after the 8 week intervention that assessed patient satisfaction using questions about likelihood of having knee surgical treatment in the 12 months that followed the study.
One question asked if patients were A. More Likely, B. Less Likely, C. Unchanged Another question asked patients to indicate on a scale of 0-100, how likely they were to get surgery where 0=unlikely and 100=very likely.
Another question that asked whether or not patients would continue to use the program after completion of the study time period.
Measured: At 8 week evaluation visit
Need for medication to treat knee osteoarthritis symptoms (Change is assessed)
Assessed in the form of a survey question that asked participants to describe the amount of medication they take for their knee osteoarthritis since the onset of the study.
The answer choices were: UNCHANGED, STOPPED, DECREASED, INCREASED, N/A
Measured: Comparison between day 0, week 4, and week 8
System Usability Scale (for intervention group)
A survey administered to get feedback on the user-friendliness of the device and application. With an optional space for additional feedback. Participants' impression of the program are assessed by presenting multiple sentences such as "I found this device easy to use" and asking the participant to rank the statement on a scale of 1 to 5, where 1 = strongly disagree and 5 = strongly agree.
Measured: At 8 week evaluation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start14 Mar 2023
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- Fitness Cubed Inc., Northwestern University
- Responsible party
- Principal investigator, Prakash Jayabalan MD, PhD, Shirley Ryan AbilityLab
- Investigators
- Prakash Jayabalan, MD, PhD, Principal investigator, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857605
- Sponsor's protocol ID
- STU00217711
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 12 May 2023
- 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 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee Osteoarthritis.
- ClinicalTrials.gov ID
- NCT05857605
- Acronym / sponsor ID
- STU00217711
- Conditions
- Osteoarthritis, Knee Osteoarthritis, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases
- Keywords
- Osteoarthritis, Knee, Knee Osteoarthritis Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- Fitness Cubed Inc., Northwestern University
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 12 May 2023 (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.
Exercise is considered the most effective, non-drug treatment for reducing pain and improving movement in patients with osteoarthritis. Diminished muscle strength is a common symptom associated with the onset of knee osteoarthritis. The evidence supports the benefit of exercise therapy, 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. The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis.
Detailed description
Objective: The primary objective of this study is to evaluate how the use of a seated compact elliptical machine (Cubii JR1) exercise program in conjunction with a standard physical therapy regimen will impact the health of individuals with knee osteoarthritis. This includes a range of motion of the knee and ankle, level of pain as measured using a standard questionnaire, muscle strength as well as satisfaction scores with this device. This study will contain two groups: A control group receiving a standard physical therapy exercise program instruction, and a treatment group that will receive standard physical therapy exercise program instruction in conjunction with a home exercise program using a seated compact elliptical machine (Cubii JR1).
Hypothesis: The hypothesis is that subjects with knee osteoarthritis who use the at-home seated compact elliptical trainer for a minimum of 30-minutes per day in conjunction with standard physical therapy program instruction will have a greater reduction in pain, increased range of motion at the knee, and ankle joint, increase in quality of life and greater quadriceps and hamstring muscle strength than those who receive just the standard physical therapy program instruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Physical Therapy exercise instructions for Knee Osteoarthritis | Active comparator | Other: Exercise for Knee OsteoarthritisParticipants enrolled in the control group will be provided standard physical therapy exercise instruction based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis. During their first visit, the participants will meet the trained research staff to trial a series of therapeutic exercises for medial knee OA. They will be provided a handout with pictures of these exercises after they have demonstrated the ability to complete them at the initial visit. The participants will then complete this program on their own for 8 weeks; performing the exercises 3 times per week. Apart from these home-based exercise sessions participants in this group will complete 3 separate evaluation sessions onsite at the beginning, interim, and end of the study where they will complete a series of functional tests and fill standard questionnaires evaluating their pain, symptoms and knee function followed by thigh muscle strength testing. |
| Standard Physical Therapy exercise instructions for Knee Osteoarthritis + seated elliptical device | Experimental | Other: Exercise for Knee Osteoarthritis, Device: Compact seated elliptical exercise machine- Cubii JR-1Participants in the intervention group will be provided physical therapy (PT) exercise instruction based on Arthritis Foundation guidelines for physical activity specific to individuals with knee OA. Participants will be provided a handout with pictures of these exercises after they have demonstrated the ability to complete them at the initial visit. They will then complete this program on their own for 8 weeks; performing the exercises 3 times per week. This group will also receive a compact seated elliptical device which they will be expected to use for a min of 30 min for 5 days per week in conjunction with PT exercise instruction. Apart from these exercise sessions participants in this group will complete 3 separate evaluation sessions on-site at the beginning, interim, and end of the study where they will complete a series of functional tests and fill standard questionnaires evaluating their pain, symptoms, and knee function followed by thigh muscle strength testing. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Exercise for Knee OsteoarthritisStandard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis. | Other | Standard Physical Therapy exercise instructions for Knee Osteoarthritis, Standard Physical Therapy exercise instructions for Knee Osteoarthritis + seated elliptical device |
| Compact seated elliptical exercise machine- Cubii JR-1Compact seated elliptical machine exerice program in conjunction with standard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis. | Device | Standard Physical Therapy exercise instructions for Knee Osteoarthritis + seated elliptical device |
Primary outcome
Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
Time frame: Comparison between day 0, week 4, and week 8
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.
13 secondary outcomes
Change in Function
Time frame: Comparison between day 0, week 4, and week 8
Change in Symptoms
Time frame: Comparison between day 0, week 4, and week 8
Impact of Osteoarthritis on Quality of Life (Change in KOOS subscale is assessed)
Time frame: Comparison between day 0, week 4, and week 8
Quality of life measured using the EQ5D survey (Change is assessed)
Time frame: Comparison between day 0, week 4, and week 8
Change in strength measure of the quadriceps and hamstring muscles
Time frame: Comparison between day 0, week 4, and week 8
Change in walking speed
Time frame: Comparison between day 0, week 4, and week 8
Change in walking endurance
Time frame: Comparison between day 0, week 4, and week 8
Stair negotiation (Change is assessed)
Time frame: Comparison between day 0, week 4, and week 8
5 times sit-to-stand (Change is assessed)
Time frame: Comparison between day 0, week 4, and week 8
Participant Exercise Log
Time frame: 8 weeks
Patient satisfaction
Time frame: At 8 week evaluation visit
Need for medication to treat knee osteoarthritis symptoms (Change is assessed)
Time frame: Comparison between day 0, week 4, and week 8
System Usability Scale (for intervention group)
Time frame: At 8 week evaluation visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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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.
Prakash Jayabalan, MD, PhD principal investigator
Shirley Ryan AbilityLab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise for Knee Osteoarthritis and Compact seated elliptical exercise machine- Cubii JR-1 in people with Osteoarthritis and Knee Osteoarthritis, run by Shirley Ryan AbilityLab 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 8 inclusion and 7 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 12 May 2023. 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 Juliana Couri (818-301-9213, jcouri02@sralab.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey) (time frame: Comparison between day 0, week 4, and week 8). 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 12 May 2023.