The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee OA
1 other identifier
interventional
28
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 14, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2023
CompletedFirst Posted
Study publicly available on registry
May 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2024
CompletedMay 12, 2023
May 1, 2023
1 year
May 2, 2023
May 11, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Comparison between day 0, week 4, and week 8
Secondary Outcomes (13)
Change in Function
Comparison between day 0, week 4, and week 8
Change in Symptoms
Comparison between day 0, week 4, and week 8
Impact of Osteoarthritis on Quality of Life (Change in KOOS subscale is assessed)
Comparison between day 0, week 4, and week 8
Quality of life measured using the EQ5D survey (Change is assessed)
Comparison between day 0, week 4, and week 8
Change in strength measure of the quadriceps and hamstring muscles
Comparison between day 0, week 4, and week 8
- +8 more secondary outcomes
Study Arms (2)
Standard Physical Therapy exercise instructions for Knee Osteoarthritis
ACTIVE COMPARATORParticipants 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
EXPERIMENTALParticipants 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.
Interventions
Standard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis.
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirley Ryan AbilityLablead
- Fitness Cubed Inc.collaborator
- Northwestern Universitycollaborator
Study Sites (1)
Shirley Ryan AbilityLab
Chicago, Illinois, 60611, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prakash Jayabalan, MD, PhD
Shirley Ryan AbilityLab
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The Principal Investigator will be masked to the patient treatment group assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Clinical Musculoskeletal Research
Study Record Dates
First Submitted
May 2, 2023
First Posted
May 12, 2023
Study Start
March 14, 2023
Primary Completion
March 31, 2024
Study Completion
March 31, 2024
Last Updated
May 12, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share