Recruiting

Seated Compact Elliptical Trainer

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05857605

Conditions

Osteoarthritis

Knee Osteoarthritis

Arthritis

Joint Diseases

Musculoskeletal Diseases

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise for Knee Osteoarthritis

Compact seated elliptical exercise machine- Cubii JR-1

Study Details

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.

Conditions

Osteoarthritis

Knee Osteoarthritis

Arthritis

Joint Diseases

Musculoskeletal Diseases

Study ID

NCT05857605

Start date

Mar 14, 2023

Status verified date

May, 2023

Completion date

Mar 31, 2024

Anticipated

Primary completion date

Mar 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Physical Therapy exercise instructions for Knee Osteoarthritis

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.

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

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.

Interventions

Exercise for Knee Osteoarthritis

Standard physical therapy exercise instructions based on Arthritis Foundation guidelines for physical activity specific to individuals with knee osteoarthritis.

Compact seated elliptical exercise machine- Cubii JR-1

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.

Primary outcome measure

  • Change in Pain subscore on the Knee injury and Osteoarthritis Score (KOOS Survey) [ Time Frame: Comparison between day 0, week 4, and week 8 ]

Central Contacts and Locations

Central contacts

Juliana Couri

818-301-9213jcouri02@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Juliana Couri

818-301-9213jcouri02@sralab.org

Vikram Darbhe

312-238-7535vdarbhe@sralab.org

Principal Investigator:

Prakash Jayabalan, MD, PhD

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 12, 2023

Last verified

May, 2023

Keywords

  • Osteoarthritis
  • Knee
  • Knee Osteoarthritis Exercise

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2023-05-12.