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Trial record 80 of 46507 for:    intensity

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03281668
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : February 5, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE November 1, 2017
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Proportion enrolled [ Time Frame: baseline ]
    percent of potential participants screened for the study who are enrolled
  • Proportion retained [ Time Frame: study completion (12 weeks) ]
    proportion of enrolled participants retained at the end of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03281668 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Compliance [ Time Frame: 12 weeks ]
    average number of training sessions completed per week
  • Adherence - sessions per week [ Time Frame: 12 weeks ]
    total number of training sessions completed per week
  • Adherence - weeks of training [ Time Frame: 12 weeks ]
    total number of training weeks completed
  • 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 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 [ 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.
  • 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.
  • Change in 40m fast paced walk test [ Time Frame: Baseline, 12 weeks ]
    Measure of the ability to walk quickly over short distances. Participants walks at fast pace that is timed over 4 x 10m.
  • Change in 30-second chair stand test [ Time Frame: Baseline, 12 weeks ]
    Number of chair stand repetitions completed in 30 seconds
  • Change in Stair climb test [ Time Frame: Baseline, 12 weeks ]
    Time in seconds to ascend and descend a flight of stairs
  • 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
  • Change in Feet Together Stand [ Time Frame: Baseline, 12 weeks ]
    Feet together stand for up to 10 seconds without assistive device
  • 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
  • Change in Tandem stand [ Time Frame: Baseline, 12 weeks ]
    One foot in front of the other, heel touching toe, for up to 10 seconds
  • Change in One Leg Stand [ Time Frame: Baseline, 12 weeks ]
    One leg stand for up to 30 seconds
  • 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.
  • Change in whole body fat mass [ Time Frame: Baseline, 12 weeks ]
    fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
  • Change in lean body mass [ Time Frame: Baseline, 12 weeks ]
    lean body mass in kilograms, measured with DXA
  • Change in visceral fat [ Time Frame: Baseline, 12 weeks ]
    visceral fat in kilograms, measured with DXA
  • Change in Knee Strength [ Time Frame: Baseline, 12 weeks ]
    Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors and extensors
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Official Title  ICMJE Feasibility of High Intensity Interval Training in Knee Osteoarthritis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthritis
Intervention  ICMJE Behavioral: High intensity interval training (HIIT)
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.
Study Arms  ICMJE Experimental: Intervention
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.
Intervention: Behavioral: High intensity interval training (HIIT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 11, 2017)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 9, 2018
Actual Primary Completion Date November 9, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03281668
Other Study ID Numbers  ICMJE 16-2996
1R21HD088852-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of North Carolina, Chapel Hill
Study Sponsor  ICMJE University of North Carolina, Chapel Hill
Collaborators  ICMJE
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators  ICMJE
Principal Investigator: Yvonne Golightly, PT, PhD University of North Carolina, Chapel Hill
PRS Account University of North Carolina, Chapel Hill
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP