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Completed

NCT Number: NCT03281668

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

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).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Interval Training (HIIT)

Behavioral

Each training session for High Intensity Interval Training 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.

Primary outcomes

  1. Percent of Potential Participants Screened for the Study Who Are Enrolled

    Time frame: Baseline

    Number of participants screened and enrolled divided by the total number of participants screened

  2. Percentage of Enrolled Participants Retained at the End of the Study

    Time frame: 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

Secondary outcomes

  1. Average Number of Training Sessions Completed Per Week

    Time frame: Weekly measures for 12 consecutive weeks

    Up to 2 training sessions were possible each week over the 12 week intervention

  2. Total Number of Training Sessions Completed

    Time frame: 12 weeks

    Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)

  3. Total Number of Training Weeks Completed

    Time frame: 12 weeks

    Total number of training weeks (up to 12 weeks possible)

  4. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks

    Time frame: 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.

  5. Change in WOMAC Pain Subscale From Baseline to 12 Weeks

    Time frame: 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.

  6. Change in WOMAC Function Subscale From Baseline to 12 Weeks

    Time frame: 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.

  7. Change in 20m Fast Paced Walk Test

    Time frame: 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.

  8. Change in Number of Chair Stand Repetitions Completed

    Time frame: Baseline, 12 weeks

    Number of chair stand repetitions completed in 30 seconds

  9. Change in Stair Climb Test

    Time frame: Baseline, 12 weeks

    Time in seconds to ascend and descend a flight of stairs

  10. Change in Timed Up and Go

    Time frame: Baseline, 12 weeks

    Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down

  11. Change in Feet Together Stand

    Time frame: Baseline, 12 weeks

    Feet together stand for up to 10 seconds without assistive device

  12. Change in Semi-tandem Stand

    Time frame: Baseline, 12 weeks

    Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds

  13. Change in Tandem Stand

    Time frame: Baseline, 12 weeks

    One foot in front of the other, heel touching toe, for up to 10 seconds

  14. Change in One Leg Stand

    Time frame: Baseline, 12 weeks

    One leg stand for up to 30 seconds

  15. Change in Cardiorespiratory Fitness

    Time frame: Baseline, 12 weeks

    Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.

  16. Change in Whole Body Fat Mass

    Time frame: Baseline, 12 weeks

    fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)

  17. Change in Lean Body Mass

    Time frame: Baseline, 12 weeks

    lean body mass in kilograms, measured with DXA

  18. Change in Visceral Fat

    Time frame: Baseline, 12 weeks

    visceral fat in kilograms, measured with DXA

  19. Change in Knee Strength

    Time frame: Baseline, 12 weeks

    Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2017
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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