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NCT05857605 | RECRUITING | Osteoarthritis

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

Shirley Ryan AbilityLab

Information provided by (Responsible Party):

Prakash Jayabalan MD, PhD

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.

Condition or disease

Osteoarthritis

Knee Osteoarthritis

Arthritis

Joint Diseases

Musculoskeletal Diseases

Rheumatic Diseases

Intervention/treatment

Exercise for Knee Osteoarthritis

Compact seated elliptical exercise machine- Cubii JR-1

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 28 participants
Masking : SINGLE
Masking Description : The Principal Investigator will be masked to the patient treatment group assignment.
Primary Purpose : TREATMENT
Official Title : The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee Osteoarthritis.
Actual Study Start Date : 2023-03-14
Estimated Primary Completion Date : 2024-03-31
Estimated Study Completion Date : 2024-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 50 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
The Impact of a Seated Compact Elliptical Trainer on Individuals With Knee OA

Location Details

NCT05857605

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How to Participate

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Locations

RECRUITING

United States, Illinois

Shirley Ryan AbilityLab

Chicago, Illinois, United States, 60611