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Completed

NCT Number: NCT03039452

High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

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.

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Key information

Conditions

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

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

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

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
  • 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 6 months
  • Diabetics (medications include exogenous insulin)
  • Total joint replacement knee surgery, other knee surgery, meniscus tear, or ACL tear in the past 12 months
  • On a waiting list for total joint replacement
  • Severely impaired hearing or speech
  • Pregnant or planning to become pregnant in the next 8 weeks
  • 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.

Treatment and study plan

High Intensity Interval Training

Behavioral

Each training session 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.

Other names: Stationary bike

Primary outcomes

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

    Time frame: baseline

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

    Time frame: 6 weeks

Secondary outcomes

  1. Compliance: average number of training session completed per week

    Time frame: 6 weeks

  2. Adherence: total number of training session completed per week

    Time frame: 6 weeks

  3. Adherence: total number of training weeks completed

    Time frame: 6 weeks

  4. Whole body metabolism measured by insulin

    Time frame: 6 weeks

  5. Whole body metabolism measured by amino acids

    Time frame: 6 weeks

  6. Whole body metabolism measured by free fatty acids

    Time frame: 6 weeks

  7. Whole body metabolism measured by an oral glucose tolerance test

    Time frame: 6 weeks

  8. Inflammation measured from interleukin-6 and tumor necrosis factor alpha

    Time frame: 6 weeks

  9. Change in Pain score from baseline to 6 weeks

    Time frame: baseline, 6 weeks

    Determined from WOMAC pain subscale (range 0-20)

  10. Change in symptomatic burden score from baseline to 6 weeks

    Time frame: baseline, 6 weeks

    Determined from the total WOMAC (range 0-96)

  11. Cardiorespiratory Fitness from peak oxygen consumption test

    Time frame: 6 weeks

  12. Knee Strength (extensors and flexors) from dynamometry

    Time frame: 6 weeks

  13. Body Composition from dual energy x-ray absorptiometry

    Time frame: 6 weeks

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

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 1, 2017
Registry last updated
Oct 31, 2017

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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