Knee Osteoarthritis
Conditions
Brief summary
Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT. Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.
Interventions
BEHAVIORALHigh intensity interval training
Each training session will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
Sponsors
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of North Carolina, Chapel Hill
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Must exhibit symptomatic knee OA (WOMAC \> 31), radiographic evidence of tibiofemoral OA (2-4 Kellgren-Lawrence scale) * Age 40-70 years * Body mass index 20-35 kg/m² * Cleared by study physician from 12 lead EKG and medical history review
Exclusion criteria
* Individuals diagnosed with a cardiovascular condition restricting exercise Individuals currently meeting Department of Health and Human Services Guidelines for Physical Activity (meeting \>150 minutes of exercise per week) * Individuals currently doing HIIT * Individuals currently participating in physical therapy for knee OA * Individuals currently participating in another OA intervention study * Received a corticosteroid or hyaluronic acid injection involved in the knee in the previous 3 weeks or scheduled for during the intervention * Diagnosis of gout in the knee * Diagnosis of Rheumatoid arthritis * Diagnosis of Fibromyalgia * Other systemic rheumatic disease * Severe dementia or other memory loss * Active diagnosis of psychosis or uncontrolled substance abuse disorder * Hospitalization for a stroke, heart attack, or heart failure, or had surgery for blocked arteries in the past 6 months * Diabetics (medications include exogenous insulin) * Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear in the past 12 months * On a waiting list for total joint replacement * Severely impaired hearing or speech * Pregnant or planning to become pregnant in the next 8 weeks * Inability to speak English * Serious or terminal illness as indicated by referral to hospice or palliative care * Nursing home residence * Inability to ride a stationary bike * Any other health problems that would prohibit safe participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility - proportion of potential participants screened for the study who are enrolled | baseline |
| Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing | 6 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence: total number of training weeks completed | 6 weeks | — |
| Whole body metabolism measured by insulin | 6 weeks | — |
| Whole body metabolism measured by amino acids | 6 weeks | — |
| Whole body metabolism measured by free fatty acids | 6 weeks | — |
| Whole body metabolism measured by an oral glucose tolerance test | 6 weeks | — |
| Compliance: average number of training session completed per week | 6 weeks | — |
| Change in Pain score from baseline to 6 weeks | baseline, 6 weeks | Determined from WOMAC pain subscale (range 0-20) |
| Change in symptomatic burden score from baseline to 6 weeks | baseline, 6 weeks | Determined from the total WOMAC (range 0-96) |
| Cardiorespiratory Fitness from peak oxygen consumption test | 6 weeks | — |
| Knee Strength (extensors and flexors) from dynamometry | 6 weeks | — |
| Body Composition from dual energy x-ray absorptiometry | 6 weeks | — |
| Inflammation measured from interleukin-6 and tumor necrosis factor alpha | 6 weeks | — |
| Adherence: total number of training session completed per week | 6 weeks | — |
Countries
United States
Outcome results
None listed