High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

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

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: High intensity interval training

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Applied Physiology Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Stationary bike

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Feasibility - proportion of potential participants screened for the study who are enrolled	baseline
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance: average number of training session completed per week		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
Whole body metabolism measured by amino acids		6 weeks
Whole body metabolism measured by free fatty acids		6 weeks
Whole body metabolism measured by an oral glucose tolerance test		6 weeks
Inflammation measured from interleukin-6 and tumor necrosis factor alpha		6 weeks
Change in Pain score from baseline to 6 weeks	Determined from WOMAC pain subscale (range 0-20)	baseline, 6 weeks
Change in symptomatic burden score from baseline to 6 weeks	Determined from the total WOMAC (range 0-96)	baseline, 6 weeks
Cardiorespiratory Fitness from peak oxygen consumption test		6 weeks
Knee Strength (extensors and flexors) from dynamometry		6 weeks
Body Composition from dual energy x-ray absorptiometry		6 weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: January 18, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): February 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 31, 2017
• Last Update Submitted That Met QC Criteria: October 27, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 16-0829; 1P2CHD086851-01 (U.S. NIH Grant/Contract)