Clinical trial NCT03281668: Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Official title: Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: Knee osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-09-13
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group assignment
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent of Potential Participants Screened for the Study Who Are Enrolled
timeFrame: Baseline
measure: Percentage of Enrolled Participants Retained at the End of the Study
timeFrame: Study completion (12 weeks)
Secondary outcomes:
measure: Average Number of Training Sessions Completed Per Week
timeFrame: Weekly measures for 12 consecutive weeks
measure: Total Number of Training Sessions Completed
timeFrame: 12 weeks
measure: Total Number of Training Weeks Completed
timeFrame: 12 weeks
measure: Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks
timeFrame: Baseline,12 weeks
measure: Change in WOMAC Pain Subscale From Baseline to 12 Weeks
timeFrame: Baseline,12 weeks
measure: Change in WOMAC Function Subscale From Baseline to 12 Weeks
timeFrame: Baseline, 12 weeks
measure: Change in 20m Fast Paced Walk Test
timeFrame: Baseline, 12 weeks
measure: Change in Number of Chair Stand Repetitions Completed
timeFrame: Baseline, 12 weeks
measure: Change in Stair Climb Test
timeFrame: Baseline, 12 weeks
measure: Change in Timed Up and Go
timeFrame: Baseline, 12 weeks
measure: Change in Feet Together Stand
timeFrame: Baseline, 12 weeks
measure: Change in Semi-tandem Stand
timeFrame: Baseline, 12 weeks
measure: Change in Tandem Stand
timeFrame: Baseline, 12 weeks
measure: Change in One Leg Stand
timeFrame: Baseline, 12 weeks
measure: Change in Cardiorespiratory Fitness
timeFrame: Baseline, 12 weeks
measure: Change in Whole Body Fat Mass
timeFrame: Baseline, 12 weeks
measure: Change in Lean Body Mass
timeFrame: Baseline, 12 weeks
measure: Change in Visceral Fat
timeFrame: Baseline, 12 weeks
measure: Change in Knee Strength
timeFrame: Baseline, 12 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Yvonne Golightly, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: