Knee OsteoarthritisNCT03281668
Feasibility of High Intensity Interval Training in Knee Osteoarthritis
A study testing High intensity interval training (HIIT) in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High intensity interval training (HIIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 9 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 23Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
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).
Read the 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
- Being tested
- High intensity interval training (HIIT)
- Keywords
- Knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval training (HIIT)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: High intensity interval training (HIIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Study completion (12 weeks)
Secondary outcomes (19)
Average Number of Training Sessions Completed Per Week
Up to 2 training sessions were possible each week over the 12 week intervention
Measured: Weekly measures for 12 consecutive weeks
Total Number of Training Sessions Completed
Total number of training sessions completed out of up to 24 sessions (2 per week over 12 weeks)
Measured: 12 weeks
Total Number of Training Weeks Completed
Total number of training weeks (up to 12 weeks possible)
Measured: 12 weeks
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.
Measured: Baseline,12 weeks
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.
Measured: Baseline,12 weeks
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.
Measured: Baseline, 12 weeks
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.
Measured: Baseline, 12 weeks
Change in Number of Chair Stand Repetitions Completed
Number of chair stand repetitions completed in 30 seconds
Measured: Baseline, 12 weeks
Change in Stair Climb Test
Time in seconds to ascend and descend a flight of stairs
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
Change in Feet Together Stand
Feet together stand for up to 10 seconds without assistive device
Measured: Baseline, 12 weeks
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
Measured: Baseline, 12 weeks
Change in Tandem Stand
One foot in front of the other, heel touching toe, for up to 10 seconds
Measured: Baseline, 12 weeks
Change in One Leg Stand
One leg stand for up to 30 seconds
Measured: Baseline, 12 weeks
Change in Cardiorespiratory Fitness
Measure by peak oxygen consumption (VO2peak),to identify fitness level and evaluate cardiovascular effects. Test will establish individual training intensity.
Measured: Baseline, 12 weeks
Change in Whole Body Fat Mass
fat mass in kilograms, measured with dual energy x-ray absorptiometry (DXA)
Measured: Baseline, 12 weeks
Change in Lean Body Mass
lean body mass in kilograms, measured with DXA
Measured: Baseline, 12 weeks
Change in Visceral Fat
visceral fat in kilograms, measured with DXA
Measured: Baseline, 12 weeks
Change in Knee Strength
Humac isokinetic dynamometer to measure isokinetic power and isometric strength of knee flexors extensors
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2017
- Study start1 Nov 2017
- Primary completion9 Nov 2018
- Study completion9 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group assignment
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Yvonne Golightly, PT, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03281668
- Sponsor's protocol ID
- 16-2996
- Other IDs
- 1R21HD088852-01A1
- Status last verified
- Jan 2019
- First submitted
- 31 Aug 2017
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of High Intensity Interval Training in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03281668
- Acronym / sponsor ID
- 16-2996
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 9 Nov 2018 (actual)
- Study completion
- 9 Nov 2018 (actual)
- First posted
- 13 Sep 2017 (actual)
- Results
- Posted 22 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: High intensity interval training (HIIT)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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention |
Primary outcome
Percent of Potential Participants Screened for the Study Who Are Enrolled
Time frame: Baseline
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
Time frame: Study completion (12 weeks)
Number of participants who completed the study (baseline through 12 week assessments) divided by the total number of enrolled participants with baseline assessments
19 secondary outcomes
Average Number of Training Sessions Completed Per Week
Time frame: Weekly measures for 12 consecutive weeks
Total Number of Training Sessions Completed
Time frame: 12 weeks
Total Number of Training Weeks Completed
Time frame: 12 weeks
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Total Score From Baseline to 12 Weeks
Time frame: Baseline,12 weeks
Change in WOMAC Pain Subscale From Baseline to 12 Weeks
Time frame: Baseline,12 weeks
Change in WOMAC Function Subscale From Baseline to 12 Weeks
Time frame: Baseline, 12 weeks
Change in 20m Fast Paced Walk Test
Time frame: Baseline, 12 weeks
Change in Number of Chair Stand Repetitions Completed
Time frame: Baseline, 12 weeks
Change in Stair Climb Test
Time frame: Baseline, 12 weeks
Change in Timed Up and Go
Time frame: Baseline, 12 weeks
Change in Feet Together Stand
Time frame: Baseline, 12 weeks
Change in Semi-tandem Stand
Time frame: Baseline, 12 weeks
Change in Tandem Stand
Time frame: Baseline, 12 weeks
Change in One Leg Stand
Time frame: Baseline, 12 weeks
Change in Cardiorespiratory Fitness
Time frame: Baseline, 12 weeks
Change in Whole Body Fat Mass
Time frame: Baseline, 12 weeks
Change in Lean Body Mass
Time frame: Baseline, 12 weeks
Change in Visceral Fat
Time frame: Baseline, 12 weeks
Change in Knee Strength
Time frame: Baseline, 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Effect of Anti-inflammatory Diet in Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yvonne Golightly, PT, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval training (HIIT) in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of Potential Participants Screened for the Study Who Are Enrolled (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.