Clinical trial NCT03039452: High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics
Official title: Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-02-01
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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.

Primary outcomes:
measure: Feasibility - proportion of potential participants screened for the study who are enrolled
timeFrame: baseline
measure: Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
timeFrame: 6 weeks
Secondary outcomes:
measure: Compliance: average number of training session completed per week
timeFrame: 6 weeks
measure: Adherence: total number of training session completed per week
timeFrame: 6 weeks
measure: Adherence: total number of training weeks completed
timeFrame: 6 weeks
measure: Whole body metabolism measured by insulin
timeFrame: 6 weeks
measure: Whole body metabolism measured by amino acids
timeFrame: 6 weeks
measure: Whole body metabolism measured by free fatty acids
timeFrame: 6 weeks
measure: Whole body metabolism measured by an oral glucose tolerance test
timeFrame: 6 weeks
measure: Inflammation measured from interleukin-6 and tumor necrosis factor alpha
timeFrame: 6 weeks
measure: Change in Pain score from baseline to 6 weeks
timeFrame: baseline, 6 weeks
measure: Change in symptomatic burden score from baseline to 6 weeks
timeFrame: baseline, 6 weeks
measure: Cardiorespiratory Fitness from peak oxygen consumption test
timeFrame: 6 weeks
measure: Knee Strength (extensors and flexors) from dynamometry
timeFrame: 6 weeks
measure: Body Composition from dual energy x-ray absorptiometry
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Applied Physiology Laboratory
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Abbie Smith-Ryan, PhD
role: PRINCIPAL_INVESTIGATOR
References: