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High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

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ClinicalTrials.gov Identifier: NCT03039452
Recruitment Status : Completed
First Posted : February 1, 2017
Last Update Posted : October 31, 2017
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

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.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: High intensity interval training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
Actual Study Start Date : January 2017
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: High intensity interval training Behavioral: High intensity interval training
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 Name: Stationary bike




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03039452


Locations
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United States, North Carolina
Applied Physiology Laboratory
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: Abbie Smith-Ryan, PhD University of North Carolina, Chapel Hill

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03039452     History of Changes
Other Study ID Numbers: 16-0829
1P2CHD086851-01 ( U.S. NIH Grant/Contract )
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases