High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: High intensity interval training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High intensity interval training<br> | Behavioral: High intensity interval training<br>* 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.<br>* Other names: Stationary bike;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance: average number of training session completed per week |  | 6 weeks | 
| Adherence: total number of training session completed per week |  | 6 weeks | 
| 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 | 
| Inflammation measured from interleukin-6 and tumor necrosis factor alpha |  | 6 weeks | 
| Change in Pain score from baseline to 6 weeks | Determined from WOMAC pain subscale (range 0-20) | baseline, 6 weeks | 
| Change in symptomatic burden score from baseline to 6 weeks | Determined from the total WOMAC (range 0-96) | baseline, 6 weeks | 
| 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 |