Knee OsteoarthritisNCT03039452
High Intensity Interval Training in Osteoarthritis, Effects on Metabolomics
A study testing High intensity interval training in people with Knee Osteoarthritis, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- High intensity interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
About this study
Official title: Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
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
- Being tested
- High intensity interval training
- 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 trainingBehavioural
Also called Stationary bike
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.
| Study group | Role | What they receive |
|---|---|---|
| High intensity interval training | Experimental | Not described Receives: Behavioral: High intensity interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - proportion of potential participants screened for the study who are enrolled
Measured: baseline
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
Measured: 6 weeks
Secondary outcomes (13)
Compliance: average number of training session completed per week
Measured: 6 weeks
Adherence: total number of training session completed per week
Measured: 6 weeks
Adherence: total number of training weeks completed
Measured: 6 weeks
Whole body metabolism measured by insulin
Measured: 6 weeks
Whole body metabolism measured by amino acids
Measured: 6 weeks
Whole body metabolism measured by free fatty acids
Measured: 6 weeks
Whole body metabolism measured by an oral glucose tolerance test
Measured: 6 weeks
Inflammation measured from interleukin-6 and tumor necrosis factor alpha
Measured: 6 weeks
Change in Pain score from baseline to 6 weeks
Determined from WOMAC pain subscale (range 0-20)
Measured: baseline, 6 weeks
Change in symptomatic burden score from baseline to 6 weeks
Determined from the total WOMAC (range 0-96)
Measured: baseline, 6 weeks
Cardiorespiratory Fitness from peak oxygen consumption test
Measured: 6 weeks
Knee Strength (extensors and flexors) from dynamometry
Measured: 6 weeks
Body Composition from dual energy x-ray absorptiometry
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2017 (estimated)
- Study startJan 2017
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Masking
- None (open label)
- Enrolment
- 15 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
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03039452
- Sponsor's protocol ID
- 16-0829
- Other IDs
- 1P2CHD086851-01
- Status last verified
- Oct 2017
- First submitted
- 18 Jan 2017
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 36474875
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Initial Effects of High Intensity Interval Training on Knee Osteoarthritis: an Exploratory Evaluation on Metabolomics
- ClinicalTrials.gov ID
- NCT03039452
- Acronym / sponsor ID
- 16-0829
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 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
- Jan 2017 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 1 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training | Experimental | Behavioral: High intensity interval training |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (22 listed)
- 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
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 trainingAlso: Stationary bikeEach 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. | Behavioural | High intensity interval training |
Primary outcome
Feasibility - proportion of potential participants screened for the study who are enrolled
Time frame: baseline
Feasibility - retention: proportion of enrolled participants retained at 6-weeks post testing
Time frame: 6 weeks
13 secondary outcomes
Compliance: average number of training session completed per week
Time frame: 6 weeks
Adherence: total number of training session completed per week
Time frame: 6 weeks
Adherence: total number of training weeks completed
Time frame: 6 weeks
Whole body metabolism measured by insulin
Time frame: 6 weeks
Whole body metabolism measured by amino acids
Time frame: 6 weeks
Whole body metabolism measured by free fatty acids
Time frame: 6 weeks
Whole body metabolism measured by an oral glucose tolerance test
Time frame: 6 weeks
Inflammation measured from interleukin-6 and tumor necrosis factor alpha
Time frame: 6 weeks
Change in Pain score from baseline to 6 weeks
Time frame: baseline, 6 weeks
Change in symptomatic burden score from baseline to 6 weeks
Time frame: baseline, 6 weeks
Cardiorespiratory Fitness from peak oxygen consumption test
Time frame: 6 weeks
Knee Strength (extensors and flexors) from dynamometry
Time frame: 6 weeks
Body Composition from dual energy x-ray absorptiometry
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2017.
- Derived from this study: PubMed 36474875Smith-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.
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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.
Abbie Smith-Ryan, 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 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 4 inclusion and 22 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 31 Oct 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility - proportion 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?
On the ClinicalTrials.gov record for NCT03039452, which also lists 1 linked publication.
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 31 Oct 2017.