High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03039452
• Other study ID #: 16-0829
• Secondary ID: 1P2CHD086851-01
• Status: Completed
• Phase: N/A
• First received: January 18, 2017
• Last updated: October 27, 2017
• Start date: January 2017
• Est. completion date: October 2017

Study information

• Verified date: October 2017
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	Applied Physiology Laboratory	Chapel Hill	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - proportion of potential participants screened for the study who are enrolled		baseline
Primary	Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing		6 weeks
Secondary	Compliance: average number of training session completed per week		6 weeks
Secondary	Adherence: total number of training session completed per week		6 weeks
Secondary	Adherence: total number of training weeks completed		6 weeks
Secondary	Whole body metabolism measured by insulin		6 weeks
Secondary	Whole body metabolism measured by amino acids		6 weeks
Secondary	Whole body metabolism measured by free fatty acids		6 weeks
Secondary	Whole body metabolism measured by an oral glucose tolerance test		6 weeks
Secondary	Inflammation measured from interleukin-6 and tumor necrosis factor alpha		6 weeks
Secondary	Change in Pain score from baseline to 6 weeks	Determined from WOMAC pain subscale (range 0-20)	baseline, 6 weeks
Secondary	Change in symptomatic burden score from baseline to 6 weeks	Determined from the total WOMAC (range 0-96)	baseline, 6 weeks
Secondary	Cardiorespiratory Fitness from peak oxygen consumption test		6 weeks
Secondary	Knee Strength (extensors and flexors) from dynamometry		6 weeks
Secondary	Body Composition from dual energy x-ray absorptiometry		6 weeks