Feasibility of High Intensity Interval Training in Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Feasibility of High Intensity Interval Training in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03281668
• Other study ID #: 16-2996
• Secondary ID: 1R21HD088852-01A
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: November 9, 2018

Study information

• Verified date: January 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: November 9, 2018
• Est. primary completion date: November 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina	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	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
Primary	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	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
Secondary	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
Secondary	Total Number of Training Weeks Completed	Total number of training weeks (up to 12 weeks possible)	12 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in Number of Chair Stand Repetitions Completed	Number of chair stand repetitions completed in 30 seconds	Baseline, 12 weeks
Secondary	Change in Stair Climb Test	Time in seconds to ascend and descend a flight of stairs	Baseline, 12 weeks
Secondary	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
Secondary	Change in Feet Together Stand	Feet together stand for up to 10 seconds without assistive device	Baseline, 12 weeks
Secondary	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
Secondary	Change in Tandem Stand	One foot in front of the other, heel touching toe, for up to 10 seconds	Baseline, 12 weeks
Secondary	Change in One Leg Stand	One leg stand for up to 30 seconds	Baseline, 12 weeks
Secondary	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
Secondary	Change in Whole Body Fat Mass	fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)	Baseline, 12 weeks
Secondary	Change in Lean Body Mass	lean body mass in kilograms, measured with DXA	Baseline, 12 weeks
Secondary	Change in Visceral Fat	visceral fat in kilograms, measured with DXA	Baseline, 12 weeks
Secondary	Change in Knee Strength	Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors	Baseline, 12 weeks