The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee OA

Shirley Ryan AbilityLab

Status: Enrolling

Conditions: Osteoarthritis; Joint Diseases; Arthritis; Musculoskeletal Diseases; Knee Osteoarthritis; Rheumatic Diseases

Treatments: Other: Exercise for Knee Osteoarthritis; Device: Compact seated elliptical exercise machine- Cubii JR-1

Study type: Interventional

Funder types: Other

Identifiers

NCT05857605

STU00217711

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 estimated patients

Sex: All

Ages: 50 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Standard Physical Therapy exercise instructions for Knee Osteoarthritis

Active Comparator group

Description:

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.

Treatment:

Other: Exercise for Knee Osteoarthritis

Standard Physical Therapy exercise instructions for Knee Osteoarthritis + seated elliptical device

Experimental group

Description:

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.

Treatment:

Device: Compact seated elliptical exercise machine- Cubii JR-1

Other: Exercise for Knee Osteoarthritis