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

Last updated: May 11, 2023
Sponsor: Shirley Ryan AbilityLab
Overall Status: Active - Recruiting

Phase

N/A

Condition

Connective Tissue Diseases

Osteoarthritis

Lupus

Treatment

Compact seated elliptical exercise machine- Cubii JR-1

Exercise for Knee Osteoarthritis

Clinical Study ID

NCT05857605
STU00217711
  • Ages 50-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, morningstiffness in the joint, crepitus on active movement, tenderness of the joint, bonyenlargement of the joint, and lack of palpable warmth of the synovium
  • Radiographic knee osteoarthritis: Kellgren-Lawrence score of 2 or greater usingradiographs of the involved knee
  • If the participant has had diagnostic radiographs within the previous 2 years atShirley Ryan AbilityLab, we will use these previous radiographs to confirm diagnosis (these participants will complete a HIPAA authorization form so that we can accessthese 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 thepurpose of this study. These images are consistent with clinical care for diagnosticOA and minimally expose the individual to radiation (see attached form from radiologytechnician). All images taken as part of the study will be stored using the assignedstudy identifier, and therefore will not require any HIPAA authorization.
  • Ability to walk without the use of aids (e.g., cane, walker)

Exclusion

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

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Compact seated elliptical exercise machine- Cubii JR-1
Phase:
Study Start date:
March 14, 2023
Estimated Completion Date:
March 31, 2024

Study 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.

Connect with a study center

  • Shirley Ryan AbilityLab

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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