Feasibility of High Intensity Interval Training in Knee Osteoarthritis

NCT ID: NCT03281668

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-01
• Study Completion Date: 2018-11-09

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).

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High intensity interval training (HIIT)

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yvonne Golightly, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R21HD088852-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

16-2996

Identifier Type: -

Identifier Source: org_study_id