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Clinical Trials/NCT03281668
NCT03281668
Completed
Not Applicable

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

University of North Carolina, Chapel Hill1 site in 1 country29 target enrollmentNovember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of North Carolina, Chapel Hill
Enrollment
29
Locations
1
Primary Endpoint
Percentage of Enrolled Participants Retained at the End of the Study
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2017
End Date
November 9, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

  • Average Number of Training Sessions Completed Per Week(Weekly measures for 12 consecutive weeks)
  • Total Number of Training Sessions Completed(12 weeks)
  • Total Number of Training Weeks Completed(12 weeks)
  • Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks(Baseline,12 weeks)
  • Change in WOMAC Pain Subscale From Baseline to 12 Weeks(Baseline,12 weeks)
  • Change in WOMAC Function Subscale From Baseline to 12 Weeks(Baseline, 12 weeks)
  • Change in 20m Fast Paced Walk Test(Baseline, 12 weeks)
  • Change in Number of Chair Stand Repetitions Completed(Baseline, 12 weeks)
  • Change in Stair Climb Test(Baseline, 12 weeks)
  • Change in Timed Up and Go(Baseline, 12 weeks)
  • Change in Feet Together Stand(Baseline, 12 weeks)
  • Change in Semi-tandem Stand(Baseline, 12 weeks)
  • Change in Tandem Stand(Baseline, 12 weeks)
  • Change in One Leg Stand(Baseline, 12 weeks)
  • Change in Cardiorespiratory Fitness(Baseline, 12 weeks)
  • Change in Whole Body Fat Mass(Baseline, 12 weeks)
  • Change in Lean Body Mass(Baseline, 12 weeks)
  • Change in Visceral Fat(Baseline, 12 weeks)
  • Change in Knee Strength(Baseline, 12 weeks)

Study Sites (1)

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