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Clinical Trials/NCT03039452
NCT03039452
Completed
Not Applicable

Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics

University of North Carolina, Chapel Hill1 site in 1 country15 target enrollmentJanuary 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
University of North Carolina, Chapel Hill
Enrollment
15
Locations
1
Primary Endpoint
Feasibility - proportion of potential participants screened for the study who are enrolled
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Purpose: The purpose of this study will be to examine the feasibility and acceptability of a 6-week high intensity interval training (HIIT) program in patients with knee OA symptoms ranging from mild to severe. A secondary purpose will be to evaluated changes in whole body metabolism induced by 6-weeks of HIIT.

Participants: Fifteen patients (age 40-70 yrs; BMI 20-35 kg/m²) with symptomatic knee OA

Procedures (methods): All participants will be assigned to the single-arm of the study in which all participants will receive 6 weeks of HIIT, delivered twice per week. Outcomes will be assessed at baseline and 6 weeks. The primary outcome will evaluate tolerability, feasibility, acceptability, compliance, and adherence to the HIIT program. Secondary outcomes will include whole body metabolism markers, inflammation, and a set of physical function including knee osteoarthritis symptomatic burden and pain, cardiorespiratory fitness, isometric knee extensor and flexor strength (factors associated with physical function and symptomatic knee OA progression), and body composition.

Registry
clinicaltrials.gov
Start Date
January 2017
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Must exhibit symptomatic knee OA (WOMAC \> 31), radiographic evidence of tibiofemoral OA (2-4 Kellgren-Lawrence scale)
  • Age 40-70 years
  • Body mass index 20-35 kg/m²
  • Cleared by study physician from 12 lead EKG and medical history review

Exclusion Criteria

  • Individuals diagnosed with a cardiovascular condition restricting exercise Individuals currently meeting Department of Health and Human Services Guidelines for Physical Activity (meeting \>150 minutes of exercise 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 injection involved in the knee in 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

Outcomes

Primary Outcomes

Feasibility - proportion of potential participants screened for the study who are enrolled

Time Frame: baseline

Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing

Time Frame: 6 weeks

Secondary Outcomes

  • Whole body metabolism measured by amino acids(6 weeks)
  • Whole body metabolism measured by an oral glucose tolerance test(6 weeks)
  • Change in Pain score from baseline to 6 weeks(baseline, 6 weeks)
  • Change in symptomatic burden score from baseline to 6 weeks(baseline, 6 weeks)
  • Body Composition from dual energy x-ray absorptiometry(6 weeks)
  • Adherence: total number of training session completed per week(6 weeks)
  • Adherence: total number of training weeks completed(6 weeks)
  • Whole body metabolism measured by insulin(6 weeks)
  • Cardiorespiratory Fitness from peak oxygen consumption test(6 weeks)
  • Whole body metabolism measured by free fatty acids(6 weeks)
  • Knee Strength (extensors and flexors) from dynamometry(6 weeks)
  • Compliance: average number of training session completed per week(6 weeks)
  • Inflammation measured from interleukin-6 and tumor necrosis factor alpha(6 weeks)

Study Sites (1)

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