Feasibility of High Intensity Interval Training in Knee Osteoarthritis

NCT03281668 | Completed Results

• 2 other identifiers: 16-29961R21HD088852-01A1
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Knee Osteoarthritis

Keywords

Knee osteoarthritis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Average Number of Training Sessions Completed Per Week

  Weekly measures for 12 consecutive weeks

• Total Number of Training Sessions Completed

  12 weeks

• Total Number of Training Weeks Completed

  12 weeks

• Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks

  Baseline,12 weeks

• Change in WOMAC Pain Subscale From Baseline to 12 Weeks

  Baseline,12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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)

Interventions

High intensity interval training (HIIT) BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

This was a single arm study so it is not known how HIIT compares to other exercise approaches or interventions for the management of knee OA.

Results Point of Contact

• Title: Yvonne Golightly, PhD
• Organization: University of North Carolina at Chapel Hill/Thurston Arthritis Research Center

golight@email.unc.edu

919-966-0566

Study Officials

• Yvonne Golightly, PT, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group assignment

Study Record Dates

• First Submitted: August 31, 2017
• First Posted: September 13, 2017
• Study Start: November 1, 2017
• Primary Completion: November 9, 2018
• Study Completion: November 9, 2018
• Last Updated: November 22, 2019
• Results First Posted: November 22, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)