Clinical trial NCT05857605: The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee OA
Official title: The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Knee Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Keywords: Osteoarthritis
Knee
Knee Osteoarthritis Exercise
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Fitness Cubed Inc.
name: Northwestern University
First posted: 2023-05-12
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey)
timeFrame: Comparison between day 0, week 4, and week 8
Secondary outcomes:
measure: Change in Function
timeFrame: Comparison between day 0, week 4, and week 8
measure: Change in Symptoms
timeFrame: Comparison between day 0, week 4, and week 8
measure: Impact of Osteoarthritis on Quality of Life (Change in KOOS subscale is assessed)
timeFrame: Comparison between day 0, week 4, and week 8
measure: Quality of life measured using the EQ5D survey (Change is assessed)
timeFrame: Comparison between day 0, week 4, and week 8
measure: Change in strength measure of the quadriceps and hamstring muscles
timeFrame: Comparison between day 0, week 4, and week 8
measure: Change in walking speed
timeFrame: Comparison between day 0, week 4, and week 8
measure: Change in walking endurance
timeFrame: Comparison between day 0, week 4, and week 8
measure: Stair negotiation (Change is assessed)
timeFrame: Comparison between day 0, week 4, and week 8
measure: 5 times sit-to-stand (Change is assessed)
timeFrame: Comparison between day 0, week 4, and week 8
measure: Participant Exercise Log
timeFrame: 8 weeks
measure: Patient satisfaction
timeFrame: At 8 week evaluation visit
measure: Need for medication to treat knee osteoarthritis symptoms (Change is assessed)
timeFrame: Comparison between day 0, week 4, and week 8
measure: System Usability Scale (for intervention group)
timeFrame: At 8 week evaluation visit
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
affiliation: Shirley Ryan AbilityLab
name: Prakash Jayabalan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: