Feasibility of High Intensity Interval Training in Knee Osteoarthritis

The focus of this pilot study is to evaluate the feasibility of utilizing an evidenced-based high intensity interval training program (HIIT) to improve physical function in patients with knee osteoarthritis (OA).

Study Overview

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

Detailed Description

All participants will be assigned to the single-arm of the study in which all participants will receive 12 weeks of HIIT, delivered twice per week. The primary outcome will examine the feasibility and acceptability of the 12 week HIIT program in patients with knee OA symptoms ranging from mild to severe. The investigators will determine adherence to and tolerability of HIIT, acceptability, and recruitment and retention rates during the 12 week program. Additional outcomes will include physical function, knee OA symptomatic burden (pain), static standing balance, isometric knee extensor and flexor strength, cardiorespiratory fitness, and body composition.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• between the ages of 40 and 75 years old
• body mass index of 18.5-50 kg/m²
• exhibits symptomatic knee OA, defined as a diagnosis of knee OA, as identified from University of North Carolina electronic medical records, and current knee symptoms in at least one knee, having a minimum score of 6 out of 20 on the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) pain subscale.

Exclusion Criteria:

• individuals diagnosed with a cardiovascular condition restricting exercise
• individuals currently meeting Department of Health and Human Services Guidelines for physical activity (≥ 150 minutes 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 intra-articular injection in the knee during 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 3 months
• total joint replacement knee surgery, other knee surgery, meniscus tear, or anterior cruciate ligament (ACL) tear in the past 6 months
• on a waiting list for total joint replacement
• severely impaired hearing or speech
• pregnant or planning to become pregnant while enrolled in the study
• 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
• EKG results EKG suggesting the individual would not be able to safely participate in this 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: Intervention; Intervention consists of High Intensity Interval Training (HIIT) session which is af 3-5 minute warm up, followed by 10 repetitions of 1 minute bouts at individualized training intensity with 1 minute rest periods.	Behavioral: High intensity interval training (HIIT); Each training session for High Intensity Interval Training 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Potential Participants Screened for the Study Who Are Enrolled	Number of participants screened and enrolled divided by the total number of participants screened	Baseline
Percentage of Enrolled Participants Retained at the End of the Study	Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments	Study completion (12 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Number of Training Sessions Completed Per Week	Up to 2 training sessions were possible each week over the 12 week intervention	Weekly measures for 12 consecutive weeks
Total Number of Training Sessions Completed	Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)	12 weeks
Total Number of Training Weeks Completed	Total number of training weeks (up to 12 weeks possible)	12 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks	The WOMAC, a measure of lower extremity pain (5 items), stiffness (2 items), and function (17 items), will be used to measure overall symptomatic burden of knee osteoarthritis (OA). Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a total WOMAC score ranging from 0 (no problems) to 96 (extreme problems). A higher score means a worse outcome.	Baseline,12 weeks
Change in WOMAC Pain Subscale From Baseline to 12 Weeks	The WOMAC pain subscale contains 5 items about knee pain. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no pain) to 20 (extreme pain). A higher score means more severe pain.	Baseline,12 weeks
Change in WOMAC Function Subscale From Baseline to 12 Weeks	The WOMAC function subscale contains 17 items about knee function during daily activities. Each item is scored from 0-4 (none, slight, moderate, severe, and extreme). Items are added to calculate a WOMAC pain score ranging from 0 (no problems with function) to 68 (extreme problems with function). A higher score means worse function.	Baseline, 12 weeks
Change in 20m Fast Paced Walk Test	Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.	Baseline, 12 weeks
Change in Number of Chair Stand Repetitions Completed	Number of chair stand repetitions completed in 30 seconds	Baseline, 12 weeks
Change in Stair Climb Test	Time in seconds to ascend and descend a flight of stairs	Baseline, 12 weeks
Change in Timed Up and Go	Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down	Baseline, 12 weeks
Change in Feet Together Stand	Feet together stand for up to 10 seconds without assistive device	Baseline, 12 weeks
Change in Semi-tandem Stand	Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds	Baseline, 12 weeks
Change in Tandem Stand	One foot in front of the other, heel touching toe, for up to 10 seconds	Baseline, 12 weeks
Change in One Leg Stand	One leg stand for up to 30 seconds	Baseline, 12 weeks
Change in Cardiorespiratory Fitness	Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.	Baseline, 12 weeks
Change in Whole Body Fat Mass	fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)	Baseline, 12 weeks
Change in Lean Body Mass	lean body mass in kilograms, measured with DXA	Baseline, 12 weeks
Change in Visceral Fat	visceral fat in kilograms, measured with DXA	Baseline, 12 weeks
Change in Knee Strength	Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors	Baseline, 12 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)
• Investigators: Principal Investigator: Yvonne Golightly, PT, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): November 9, 2018
• Study Completion (Actual): November 9, 2018

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): November 22, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Knee osteoarthritis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 16-2996; 1R21HD088852-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No