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Feasibility of High Intensity Interval Training in Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High intensity interval training (HIIT)
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 focused on measuring Knee osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of North Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Average Number of Training Sessions Completed Per Week
Up to 2 training sessions were possible each week over the 12 week intervention
Total Number of Training Sessions Completed
Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
Total Number of Training Weeks Completed
Total number of training weeks (up to 12 weeks possible)
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.
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.
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.
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.
Change in Number of Chair Stand Repetitions Completed
Number of chair stand repetitions completed in 30 seconds
Change in Stair Climb Test
Time in seconds to ascend and descend a flight of stairs
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
Change in Feet Together Stand
Feet together stand for up to 10 seconds without assistive device
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
Change in Tandem Stand
One foot in front of the other, heel touching toe, for up to 10 seconds
Change in One Leg Stand
One leg stand for up to 30 seconds
Change in Cardiorespiratory Fitness
Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
Change in Whole Body Fat Mass
fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
Change in Lean Body Mass
lean body mass in kilograms, measured with DXA
Change in Visceral Fat
visceral fat in kilograms, measured with DXA
Change in Knee Strength
Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors

Full Information

First Posted
August 31, 2017
Last Updated
November 4, 2019
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
NCT03281668
Brief Title
Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Official Title
Feasibility of High Intensity Interval Training in Knee Osteoarthritis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
November 9, 2018 (Actual)
Study Completion Date
November 9, 2018 (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

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
High intensity interval training (HIIT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent of Potential Participants Screened for the Study Who Are Enrolled
Description
Number of participants screened and enrolled divided by the total number of participants screened
Time Frame
Baseline
Title
Percentage of Enrolled Participants Retained at the End of the Study
Description
Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments
Time Frame
Study completion (12 weeks)
Secondary Outcome Measure Information:
Title
Average Number of Training Sessions Completed Per Week
Description
Up to 2 training sessions were possible each week over the 12 week intervention
Time Frame
Weekly measures for 12 consecutive weeks
Title
Total Number of Training Sessions Completed
Description
Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
Time Frame
12 weeks
Title
Total Number of Training Weeks Completed
Description
Total number of training weeks (up to 12 weeks possible)
Time Frame
12 weeks
Title
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks
Description
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.
Time Frame
Baseline,12 weeks
Title
Change in WOMAC Pain Subscale From Baseline to 12 Weeks
Description
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.
Time Frame
Baseline,12 weeks
Title
Change in WOMAC Function Subscale From Baseline to 12 Weeks
Description
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.
Time Frame
Baseline, 12 weeks
Title
Change in 20m Fast Paced Walk Test
Description
Measure of the ability to walk quickly over short distances. Participants walk at fast pace that is timed over 2 x 10m.
Time Frame
Baseline, 12 weeks
Title
Change in Number of Chair Stand Repetitions Completed
Description
Number of chair stand repetitions completed in 30 seconds
Time Frame
Baseline, 12 weeks
Title
Change in Stair Climb Test
Description
Time in seconds to ascend and descend a flight of stairs
Time Frame
Baseline, 12 weeks
Title
Change in Timed Up and Go
Description
Time in seconds to rise from a chair, walk 3 m, turn, walk back to chair, and sit down
Time Frame
Baseline, 12 weeks
Title
Change in Feet Together Stand
Description
Feet together stand for up to 10 seconds without assistive device
Time Frame
Baseline, 12 weeks
Title
Change in Semi-tandem Stand
Description
Heel of one foot placed to the side of the big toe of the other foot, for up to 10 seconds
Time Frame
Baseline, 12 weeks
Title
Change in Tandem Stand
Description
One foot in front of the other, heel touching toe, for up to 10 seconds
Time Frame
Baseline, 12 weeks
Title
Change in One Leg Stand
Description
One leg stand for up to 30 seconds
Time Frame
Baseline, 12 weeks
Title
Change in Cardiorespiratory Fitness
Description
Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
Time Frame
Baseline, 12 weeks
Title
Change in Whole Body Fat Mass
Description
fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
Time Frame
Baseline, 12 weeks
Title
Change in Lean Body Mass
Description
lean body mass in kilograms, measured with DXA
Time Frame
Baseline, 12 weeks
Title
Change in Visceral Fat
Description
visceral fat in kilograms, measured with DXA
Time Frame
Baseline, 12 weeks
Title
Change in Knee Strength
Description
Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Golightly, PT, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of High Intensity Interval Training in Knee Osteoarthritis

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