High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

NCT03039452 | Completed

• 2 other identifiers: 16-08291P2CHD086851-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Feasibility - proportion of potential participants screened for the study who are enrolled

  baseline

• Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing

  6 weeks

Secondary Outcomes (13)

• Compliance: average number of training session completed per week

  6 weeks

• Adherence: total number of training session completed per week

  6 weeks

• Adherence: total number of training weeks completed

  6 weeks

• Whole body metabolism measured by insulin

  6 weeks

• Whole body metabolism measured by amino acids

  6 weeks

Study Arms (1)

High intensity interval training

EXPERIMENTAL

Behavioral: High intensity interval training

Interventions

High intensity interval training BEHAVIORAL

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.

Also known as: Stationary bike

High intensity interval training

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 (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

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)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Smith-Ryan AE, Blue MNM, Anderson KC, Hirsch KR, Allen KD, Huebner JL, Muehlbauer MJ, Ilkayeva OR, Kraus VB, Kraus WE, Golightly YM, Huffman KM. Metabolic and physiological effects of high intensity interval training in patients with knee osteoarthritis: A pilot and feasibility study. Osteoarthr Cartil Open. 2020 Jun 10;2(4):100083. doi: 10.1016/j.ocarto.2020.100083. eCollection 2020 Dec.

  PMID: 36474875 DERIVED

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

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 18, 2017
• First Posted: February 1, 2017
• Study Start: January 1, 2017
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

US (1)