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High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity interval training
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Severely impaired hearing or speech
  • Pregnant or planning to become pregnant in the next 8 weeks
  • 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.

Sites / Locations

  • Applied Physiology Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High intensity interval training

Arm Description

Outcomes

Primary Outcome Measures

Feasibility - proportion of potential participants screened for the study who are enrolled
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing

Secondary Outcome Measures

Compliance: average number of training session completed per week
Adherence: total number of training session completed per week
Adherence: total number of training weeks completed
Whole body metabolism measured by insulin
Whole body metabolism measured by amino acids
Whole body metabolism measured by free fatty acids
Whole body metabolism measured by an oral glucose tolerance test
Inflammation measured from interleukin-6 and tumor necrosis factor alpha
Change in Pain score from baseline to 6 weeks
Determined from WOMAC pain subscale (range 0-20)
Change in symptomatic burden score from baseline to 6 weeks
Determined from the total WOMAC (range 0-96)
Cardiorespiratory Fitness from peak oxygen consumption test
Knee Strength (extensors and flexors) from dynamometry
Body Composition from dual energy x-ray absorptiometry

Full Information

First Posted
January 18, 2017
Last Updated
October 27, 2017
Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03039452
Brief Title
High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics
Official Title
Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High intensity interval training
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training
Other Intervention Name(s)
Stationary bike
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - proportion of potential participants screened for the study who are enrolled
Time Frame
baseline
Title
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Compliance: average number of training session completed per week
Time Frame
6 weeks
Title
Adherence: total number of training session completed per week
Time Frame
6 weeks
Title
Adherence: total number of training weeks completed
Time Frame
6 weeks
Title
Whole body metabolism measured by insulin
Time Frame
6 weeks
Title
Whole body metabolism measured by amino acids
Time Frame
6 weeks
Title
Whole body metabolism measured by free fatty acids
Time Frame
6 weeks
Title
Whole body metabolism measured by an oral glucose tolerance test
Time Frame
6 weeks
Title
Inflammation measured from interleukin-6 and tumor necrosis factor alpha
Time Frame
6 weeks
Title
Change in Pain score from baseline to 6 weeks
Description
Determined from WOMAC pain subscale (range 0-20)
Time Frame
baseline, 6 weeks
Title
Change in symptomatic burden score from baseline to 6 weeks
Description
Determined from the total WOMAC (range 0-96)
Time Frame
baseline, 6 weeks
Title
Cardiorespiratory Fitness from peak oxygen consumption test
Time Frame
6 weeks
Title
Knee Strength (extensors and flexors) from dynamometry
Time Frame
6 weeks
Title
Body Composition from dual energy x-ray absorptiometry
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Severely impaired hearing or speech Pregnant or planning to become pregnant in the next 8 weeks 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abbie Smith-Ryan, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Physiology Laboratory
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

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High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics

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