Feasibility of High Intensity Interval Training in Knee Osteoarthritis

Not Applicable

Completed

Conditions: Knee Osteoarthritis

Interventions: Behavioral: High intensity interval training (HIIT)

Registration Number: NCT03281668

Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary: The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).

Detailed Description: All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 29

Inclusion Criteria

between the ages of 40 and 75 years old
body mass index of 18.5-50 kg/m²
exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.

Exclusion Criteria

individuals diagnosed with a cardiovascular condition restricting exercise
individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes 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 intra-articular injection in the knee during 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 3 months
total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months
on a waiting list for total joint replacement
severely impaired hearing or speech
pregnant or planning to become pregnant while enrolled in the study
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
EKG results EKG suggesting the individual would not be able to safely participate in this study

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	High intensity interval training (HIIT)	Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.

Primary Outcome Measures

Name	Time	Method
Percentage of Enrolled Participants Retained at the End of the Study	Study completion (12 weeks)	Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments
Percent of Potential Participants Screened for the Study Who Are Enrolled	Baseline	Number of participants screened and enrolled divided by the total number of participants screened

Secondary Outcome Measures

Name	Time	Method
Change in Feet Together Stand	Baseline, 12 weeks	Feet together stand for up to 10 seconds without assistive device
Change in Semi-tandem Stand	Baseline, 12 weeks	Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds
Change in Tandem Stand	Baseline, 12 weeks	One foot in front of the other, heel touching toe, for up to 10 seconds
Change in One Leg Stand	Baseline, 12 weeks	One leg stand for up to 30 seconds
Change in Cardiorespiratory Fitness	Baseline, 12 weeks	Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
Change in Whole Body Fat Mass	Baseline, 12 weeks	fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
Change in Lean Body Mass	Baseline, 12 weeks	lean body mass in kilograms, measured with DXA
Change in Visceral Fat	Baseline, 12 weeks	visceral fat in kilograms, measured with DXA
Change in Knee Strength	Baseline, 12 weeks	Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors
Average Number of Training Sessions Completed Per Week	Weekly measures for 12 consecutive weeks	Up to 2 training sessions were possible each week over the 12 week intervention
Total Number of Training Sessions Completed	12 weeks	Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
Total Number of Training Weeks Completed	12 weeks	Total number of training weeks (up to 12 weeks possible)
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks	Baseline,12 weeks	The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.
Change in WOMAC Pain Subscale From Baseline to 12 Weeks	Baseline,12 weeks	The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.
Change in WOMAC Function Subscale From Baseline to 12 Weeks	Baseline, 12 weeks	The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.
Change in 20m Fast Paced Walk Test	Baseline, 12 weeks	Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.
Change in Number of Chair Stand Repetitions Completed	Baseline, 12 weeks	Number of chair stand repetitions completed in 30 seconds
Change in Stair Climb Test	Baseline, 12 weeks	Time in seconds to ascend and descend a flight of stairs
Change in Timed Up and Go	Baseline, 12 weeks	Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down